Published on 4 June 2026

ADHD

• Dexmethylphenidate

ALL

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
• Inotuzumab ozogamicine ^IND
• Obecabtagene autoleucel

• Ponatinib

  • Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).

ALS

• Cnm-au8
• Lenzumestrocel

AML / MDS

• Decitabine / cedazuridine

  • Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
• Galinpepimut-S

• Gemtuzumab ozogamicin

  • In combination with mitoxantrone and cytarabine (AraC), the treatment of paediatric patients aged 1 year to less than 18 years with newly diagnosed CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
• Imetelstat
• Revumenib

• Venetoclax

  • Newly diagnosed high-risk myelodysplastic syndrome in adults and elderly.
• Ziftomenib

Aggressive non-Hodgkin’s lymphoma

• Acalabrutinib

  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.
  • Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).
  • diffuse large B-cell lymphoma (based on study ESCALADE- ACE-LY-312)); Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL.

• Brentuximab vedotin

  • Brentuximab vedotin in combination with lenalidomide and rituximab for third line or later treatment of relapsed or refractory Diffuse large B-cell lymphoma in adults and elderly ineligible for haematopoietic stem cell transplantation or CAR-T therapy.

• Epcoritamab

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • 1L Diffuse Large B-Cell Lymphoma (E + R-CHOP)
  • 2L Diffuse Large B-Cell Lymphoma`(E + len)

• Ibrutinib

  • Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (Imbruvica + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).

• Loncastuximab tesirine

  • Loncastuximab tesirine in combination with rituximab for second line or later treatment of relapsed or refractory Diffuse large B-cell lymphoma in adults and elderly who are ineligible for stem cell transplantation.

• Pirtobrutinib

  • Pirtobrutinib monotherapie voor de tweedelijns of latere behandeling van mantelcellymfoom bij volwassenen en ouderen die nog geen BTK-remmer hebben gebruikt.
• Sonrotoclax

• Tafasitamab

  • Tafasitamab in combinatie met lenalidomide is geïndiceerd in combinatie met rituximab, cyclofosfamide, doxorubicine, vincristine en prednison (R-CHOP) voor de behandeling van volwassen patiënten met onbehandeld diffuus groot cellig B-cellymfoom (DLBCL).

• Zamtocabtagene autoleucel

  • Treatment of adults with large B-cell lymphoma
  • Zamtocabtagene autoleucel monotherapy for third line or later treatment of relapsed/refractory Diffuse large B-cell lymphoma in adults and elderly who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

Antithrombotic medications

• Apixaban oraal oplosbare film
• Asundexian
• Edaravone / dexborneol

Asthma

• Beclometason / formoterol / glycopyrroniumbromide ^IND
• Depemokimab

• Formoterol / glycopyronium / budesonide

  • Budesonide/glycopyrronium/formoterol monotherapy for treatment of severe inadequately controlled Asthma in adolescents, adults and elderly.

Bacterial infections

• Amikacine ^IND
• Cefepime / zidebactam

• Cefiderocol

  • Extension of indication to include treatment of infections due to aerobic Gram-negative organisms in paediatric (birth to less than 18 years old) patients with limited treatment options.
• Ceftozolaan / tazobactam ^IND
• Contezolid

• Dalbavancine

  • Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth.
• Doxycycline

• Eravacycline

  • Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI).
• Imipenem / cilastatin / funobactam

• Imipenem / cilastatin / relebactam

  • Recarbrio is indicated in adult and paediatric patients from birth for: - Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) (see sections 4.4 and 5.1). - Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP. - Treatment of infections due to aerobic Gram-negative organisms with limited treatment options (see sections 4.2, 4.4, and 5.1).

• Minocycline

  • Minocycline in combination with standard antibiotics for adjunctive treatment of catheter-related infections and central line sepsis in adolescents, adults and the elderly.
• Nacubactam

• Pretomanid

  • Dovprela is indicated in combination with bedaquiline, linezolid and moxifloxacin for the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid. Dovprela is indicated in combination with bedaquiline and linezolid for the treatment of adults with pulmonary TB due to M. tuberculosis resistant to rifampicin and a fluoroquinolone, with or without resistance to isoniazid (see sections 4.2, 4.4 and 5.1).
• Zoliflodacin ^BS

Bladder cancer

• Cretostimogene grenadenorepvec
• Detalimogene voraplasmid
• Disitamab Vedotin

• Durvalumab

  • Extension of indication for IMFINZI in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).
  • Durvalumab in combination with enfortumab vedotin for neoadjuvant and durvalumab monotherapy for adjuvant treatment of muscle-invasive urothelial carcinoma bladder in adults and elderly who are cisplatin-ineligible or refused cisplatin and are undergoing radical cystectomy (VOLGA).
  • Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy.
  • Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).

• Enfortumab vedotin

  • Enfortumab vedotin in combination with pembrolizumab indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults who are eligible for platinum-containing chemotherapy.
  • Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy
• Mitomycine (UGN-103)
• Mitomycine extended release
• Nadofaragene firadenovec

• Nivolumab

  • Extension of indication to include in combination with cisplatin-based chemotherapy the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

• Nogapendekin alfa inbakicept

  • Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
  • Nogapendekin alfa inbakicept in combination with bacillus calmette-guerin for second line treatment of BCG-unresponsive, high-grade Ta/T1 disease non-muscle invasive bladder cancer in adults and elderly.
• Paclitaxel/hyaluronzuur

• Padeliporfin

  • Padeliporfin monotherapy for first line treatment of low grade non-invasive Renal pelvis and ureter transitional cell cancer localized in adults and elderly.

• Pembrolizumab

  • Pembrolizumab in combination with gemcitabine and cisplatin followed by surgery and postoperative pembrolizumab for neoadjuvant treatment of non-metastatic muscle invasive Bladder cancer in adults and elderly who are eligible for radical cystectomy and pelvic lymph node dissection.
  • Pembrolizumab in combination with Bacillus Calmette-Guerin for adjuvant treatment of high risk non-muscle invasive bladder cancer in adults and elderly who have undergone cystoscopy/TURBT and are BCG-naive.
  • Keytruda, in combination with chemoradiotherapy, is indicated for the treatment of adults with muscle-invasive bladder cancer (MIBC) who choose bladder preservation.
  • Extension of indication to include KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with muscle invasive bladder cancer (MIBC) who are eligible for cisplatin containing chemotherapy.
• Sasanlimab
• TAR-200

Bowel diseases

• Apraglutide

• Budesonide

  • Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

• Etrasimod

  • For the treatment of patients aged 16 years and older with moderately to severely active ulcerative colitis (UC) who have an inadequate response, no longer respond to, or are intolerant of conventional treatment or a biological agent.
• Glepaglutide

• Golimumab

  • Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

• Guselkumab

  • Tremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.

• Mirikizumab

  • Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
• Obefazimod

• Teduglutide

  • Treatment of Short Bowel Syndrome.
• Tegoprazan

• Ustekinumab

  • Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
  • Extension of indication to include treatment of ulcerative colitis in paediatric patients from the age of 2 years and older.

• Vedolizumab

  • Ulcerative colitis (UC) and of Crohn’s disease (CD) in the paediatric population from 2 to less than 18 years for Entyvio 300 mg powder for concentrate for solution for infusion.

Brain cancer

• Berubicin
• Dordaviprone
• Idroxioleenzuur
• Naxitamab

• Tovorafenib

  • Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
  • Tovorafenib monotherapy for first line treatment of patients 6 months of age and olders with non-resectable or subtotally resected pediatric low grade glioma harbouring a BRAF fusion or rearrangement or BRAF V600 mutation. Indicatiestelling is inschatting obv lopende fase III studie FIREFLY 2/LOGGIC:
• Vorasidenib

Breast cancer

• Alpelisib

  • Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/​6 Inhibitor and an Aromatase Inhibitor.

• Camizestrant

  • Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1‑mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor
  • Camizestrant in combination with palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.

• Capivasertib

  • Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

• Datopotamab deruxtecan

  • Extension of indication to include, as monotherapy, the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
• Eftilagimod alfa
• GLSI-100

• Gedatolisib

  • Gedatolisib in combination with palbociclib and fulvestrant for second line or later treatment of advanced or metastatic PIK3CA mutated Hormone receptor positive HER2 negative breast cancer in adults and elderly previously treated with CDK4/6 and aromatase inhibitor therapy.

• Giredestrant

  • Giredestrant in combination with palbociclib for first line treatment of locally advanced or metastatic ER-positive HER2-negative breast cancer in adults and elderly.
  • Giredestrant in combinatie met everolimus voor de tweedelijnsbehandeling van lokaal gevorderde of gemetastaseerde, niet-reseceerbare, HR-positieve, HER2-negatieve borstkanker, na voorgaande behandeling met een CDK4/6-remmer plus endocriene therapie.
  • Giredestrant monotherapie als adjuvante behandeling van medium/high risk stadium I-III HR-positieve, HER2-negatieve borstkanker.
• Imlunestrant
• Inavolisib

• Olaparib

  • Monotherapie of in combinatie met endocriene therapie voor de adjuvante behandeling van volwassen patiënten met kiembaan-BRCA1/2-mutaties die HER2-negatieve, hoog-risico borstkanker in een vroeg stadium hebben en eerder behandeld zijn met neoadjuvante of adjuvante chemotherapie.

• Paclitaxel

  • Paclitaxel monotherapy for first line treatment of recurrent or metastatic HER2 negative breast cancer in adults over 19 years of age and elderly.
• Palazestrant

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.
  • Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.

• Pembrolizumab

  • Pembrolizumab in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy for treatment of high risk early-stage, grade 3 ER-positive, HER2-negative Breast cancer in adults and elderly

• Pertuzumab

  • Indicated for use in combination with trastuzumab and chemotherapy in: • The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. • The adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. It is also indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

• Ribociclib

  • Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali.

• Sacituzumab govitecan

  • Trodelvy is indicated as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy
• Sacituzumab tirumotecan

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
  • Treatment of adult patients with HER2-positive breast cancer (IHC3+ or ISH+) who have residual invasive disease after neoadjuvant HER2 targeted treatment.
  • Extension of indication to include the indication first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab.

• Trastuzumab pamirtecan

  • Trastuzumab pamirtecan (Db-1303/bnt323) monotherapy for third line or later treatment of advanced or metastatic HER2-low, HR-positive Breast cancer in adults and elderly whose disease has progressed on endocrine therapy and/or cyclin-dependent kinase 4/6 (CDK4/6) therapy and who are chemotherapy-naïve.

• Tucatinib

  • In combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
• Vepdegestrant

CLL

• Bgb-16673

  • Second line treatment of relapsed or refractory Chronic lymphocytic leukaemia in adults and elderly previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
• Nemtabrutinib

• Pirtobrutinib

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor.
  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL).

• Venetoclax

  • Extension of indication to include, in combination with ibrutinib, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Extension of indication to include, in combination with acalabrutinib with or without obinutuzumab, the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

CML

• Asciminib

  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP).
  • Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.

• Bosutinib

  • Paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). Paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

• Ponatinib

  • Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
  • Treatment of chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults.

COPD

• Dupilumab

  • Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
• Itepekimab

• Mepolizumab

  • Nucala is indicated in adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) (see section 5.1).

• Tozorakimab

  • Tozorakimab monotherapy for treatment of symptomatic Chronic obstructive pulmonary disease in adults and elderly with history of COPD exacerbations.

COVID-19

• Ensitrelvir

  • Treatment of coronavirus disease 2019 (COVID-19).
• Ibramvibart
• Ibuzatrelvir
• Nirmatrelvir / ritonavir ^IND
• Pemivibart

• Remdesivir

  • Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg).
• Sipavibart
• Vilobelimab

Cervical cancer

• Hexaminolevulinaathydrochloride
• Tisotumab vedotin

Colon cancer

• Atezolizumab

  • Tecentriq in combination with chemotherapy for the treatment of patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
• Cetuximab ^IND

• Encorafenib

  • Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation

• Nivolumab

  • Extension of indication to include OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or metastatic mismatch repair deficient or microsatellite instability-high colorectal cancer.

• Sotorasib

  • Sotorasib in combination with panitumumab for first-line treatment of KRAS p.G12C mutated metastatic colorectal cancer .

• Tucatinib

  • Treatment of patients with unresectable locally advanced or metastatic HER2 positive colorectal cancer.

• Zanzalintinib

  • Zanzalintinib in combination with atezolizumab for third line treatment of microsatellite stable or microsatellite instability low metastatic colorectal cancer in adults and elderly who have progressed after or are intolerant to standard-of-care therapy.

Cystic fibrosis

• Ivacaftor / Tezacaftor / Elexacaftor

  • Extension of the indication for Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor) in a combination regimen to include the treatment of patients with cystic fibrosis (CF) aged 2 years and older who do not carry any F508del mutations and have at least one ivacaftor/tezacaftor/elexacaftor-responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
  • Treatment of cystic fibrosis (CF) in paediatric patients aged 1 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene).
• Vanzacaftor / tezacaftor / deutivacaftor

Dementia

• Blarcamesine
• Donanemab
• Lecanemab
• Masupirdine

Depression

• Psilocybine
• Seltorexant
• Zuranolone

Diabetes

• Cagrilintide / semaglutide

• Ertugliflozin

  • Ertugliflozin in combination with metformin with or without insulin for treatment of Type 2 diabetes mellitus in children over 10 years of age and adolescents.
• Glibenclamide ^IND
• Insulin efsitora alfa

• Insulin icodec / semaglutide

  • Treatment of adults with type 2 diabetes mellitus insufficiently controlled on basal insulin or glucagon-like peptide 1 (GLP-1) receptor agonists.
  • Extension of indication to include treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
• Insulin oral
• Orforglipron

• Tarcocimab tedromer

  • Moderately severe to severe non-proliferative diabetic retinopathy in adults and elderly with type 1 or 2 diabetes mellitus.
• Teplizumab

• Tirzepatide

  • Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes.

Duchenne

• Casimersen
• Delpacibart zotadirsen
• Deramiocel

• Givinostat

  • Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
• Golodirsen

• Vamorolone

  • Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 2 years and older.

Epilepsy

• Bexicaserin
• Cannabis Extract Ycj-01

• Cenobamaat

  • Cenobamate monotherapy for adjunctive treatment of primary generalised tonic-clonic seizure in adolescents, adults and elderly with idiopathic generalised epilepsy

• Fenfluramine

  • CDKL5 syndroom
  • Dravet Syndroom < 2 jaar
• Opakalim
• Zonisamide ^IND

Eye disorders

• AVD-104
• Aceclidine
• Acoltremon
• Atropinesulfaat ^IND
• Brimonidine tartrate/carbachol
• Citicoline
• IBI311
• Midazolam/ketamine
• OCU400

• Ranibizumab

  • Treatment of neovascular age-related macular degeneration (AMD).
  • Treatment of diabetic macular edema (DME).
• Revakinagene Taroretcel
• Ripasudil
• Sonpiretigene Isteparvovec

• Tarcocimab tedromer

  • Macular edema due to retinal vein occlusion (RVO).
• Teprotumumab
• Tinlarebant ^G
• Vamikibart
• Veligrotug

Fungal infections

• Olorofim

• Posaconazol

  • Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104.

Graft versus Host

• Belumosudil
• Cyp-001
• MaaT013

HIV

• Darunavir / cobicistat

  • Darunavir/cobicistat for add-on treatment of HIV-1 infection in children over 3 years of age weighing at least 15kg.

• Darunavir / cobicistat / emtricitabine / tenofovir alafenamide

  • Darunavir/cobicistat/emtricitabine/tenofovir alafenamide combination therapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25kg.

• Dolutegravir / Lamivudine

  • Extension application to include treatment of children weighing at least 20 kg for Dovato.
• Doravirine / islatravir
• Emtricitabine/tenofovir alafenamide ^G

• Lenacapavir

  • The full indication for Yeytuo solution for injection is:  Yeytuo injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). The full indication for Yeytuo film-coated tablets is: Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV1 acquisition risk, weighing at least 35 kg for: oral loading, oral bridging.

Head and neck cancer

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.

• Tislelizumab

  • Extension of indication to include, Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC).

Headache

• Atogepant

  • Acute treatment of migraine with or without aura in adults

• Botulinetoxine-A

  • Btx-a monotherapy for preventive treatment of episodic Migraine in adults and elderly
  • Btx-a monotherapy for preventive treatment of chronic Migraine in adults and elderl

• Eptinezumab

  • Eptinezumab monotherapy for preventive treatment of with or without aura chronic Migraine in adolescents.

• Fremanezumab

  • Fremanezumab monotherapy for preventive treatment of Chronic migraine, Episodic migraine in children over 6 years of age and adolescents.

Hemostasis promoting medication

• Fibrinogen

• Turoctocog alfa pegol

  • Extension of indication to include children below 12 years of age for treatment and prophylaxis of bleeding with haemophilia A for Esperoct, including previously untreated patients (PUPs).
• Valoctocogene roxaparvovec

• Vonicog alfa

  • Treatment of haemorrhage in children (aged less than 18 years) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Hodgkin's lymphoma

• Brentuximab vedotin

  • Adcetris is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage 3 or Stage 4 HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1)

• Nivolumab

  • Opdivo in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.
  • Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

• Tislelizumab

  • Tislelizumab monotherapy for third line, salvage treatment of relapsed or refractory classical Hodgkin lymphoma in adults and elderly.

Indolent non-Hodgkin’s lymphoma

• Epcoritamab

  • Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

• Lisocabtagene maraleucel

  • Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory Marginal zone lymphoma in adults and elderly previously treated with systemic therapies including anti-CD20 and alkylating agent or relapsed after haematopoietic stem cell transplant.
  • Lisocabtagene maraleucel is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
  • Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
• Orelabrutinib

• Tafasitamab

  • Tafasitamab in combinatie met lenalidomide en rituximab voor de behandeling van volwassen patiënten met een gerecidiveerd of refractair folliculair lymfoom (FL) (graad 1-3a) na tenminste één eerdere systemische behandeling.

• Tisagenlecleucel-T

  • Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Kidney cancer

• Abexinostat

• Belzutifan

  • In combination with lenvatinib for treatment of advanced or metastatic clear cell renal cell carcinoma.
  • WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
  • Belzutifan in combination with lenvatinib for advanced renal cell carcinoma.
  • Belzutifan In combination with pembrolizumab, for the adjuvant treatment of adult patients with clear cell renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

• Pembrolizumab

  • Pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma.

• Zanzalintinib

  • Zanzalintinib in combination with nivolumab for first line treatment of unresectable, locally advanced or metastatic non-clear cell renal cell carcinoma in adults and elderly.

Lipid-lowering medications

• Enlicitide decanoate

• Evolocumab

  • Extension of indication to extend the indication for REPATHA to include adults at high risk for a first cardiovascular event.

• Inclisiran

  • Extension of indication to include the treatment of paediatric patients aged 12 to less than 18 years with homozygous or heterozygous familial hypercholesterolaemia (HoFH/HeFH).

• Lerodalcibep

  • Is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet.
  • Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy with history of CVD, monotherapy for add-on treatment.
• Lomitapide ^IND
• Obicetrapib
• Obicetrapib / ezetimibe

• Olezarsen

  • Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
  • Olezarsen monotherapy for add-on treatment of severe hypertriglyceridemia in adults and elderly.
• Pegozafermine
• Pelacarsen
• Plozasiran

Liver cancer

• Atezolizumab

  • Atezolizumab in combination with lenvatinib for second line treatment of locally advanced or metastatic and/or unresectable hepatocellular carcinoma in adults and elderly who have progressed on prior systemic treatment with atezolizumab plus bevacizumab.
• Camrelizumab

• Durvalumab

  • IMFINZI in combinatie met tremelimumab is geïndiceerd voor de eerstelijnsbehandeling van volwassenen met gevorderd of irresectabel hepatocellulair carcinoom (HCC).
  • Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.
  • Durvalumab monotherapy for adjuvant treatment of newly diagnosed Hepatocellular carcinoma in adults and elderly who are at high risk of recurrence after curative hepatic resection or ablation
• Namodenoson

• Nivolumab

  • Extension of indication to include a new indication for OPDIVO in combination with ipilimumab as first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) based on study CA2099DW.
• Nofazinlimab
• Tinengotinib

• Tremelimumab

  • Tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC) (EMERALD-3).
  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Liver diseases

• Linerixibat
• Norucholzuur

• Odevixibat

  • Odevixibat behandeling van galgangatresie (biliary atresia) bij kinderen die een Kasai-operatie hebben gehad. Indicatiestelling is inschatting op basis van lopende fase 3 studie BOLD:
• Resmetirom
• Saroglitazar
• Seladelpar

• Semaglutide

  • Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).

Lung cancer

• Amivantamab

  • Amivantamab in combination with lazertinib is indicated for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor.
  • Amivantamab monotherapy for treatment of locally advanced or metastatic EGFR-mutated Non-small cell lung cancer in adults and elderly who are not amenable to curative therapy including surgical resection or chemoradiation.

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
• Aumolertinib (mesilate)
• Ceralasertib
• Cobolimab

• Datopotamab deruxtecan

  • Datopotamab deruxtecan with or without osimertinib is indicated for patients with advanced or metastatic EGFRm NSCLC whose disease has progressed on prior Osimertinib.

• Durvalumab

  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.
  • A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy. PACIFIC-9.
• Ensartinib
• Furmonertinib

• Ivonescimab

  • Ivonescimab in combination with pemetrexed and carboplatin for second line treatment of locally advanced or metastatic EGFR-mutant Non-squamous non-small cell lung cancer in adults and elderly who have progressed on or following EGFR-TKI treatment.
  • Ivonescimab in combination with chemotherapy for first line treatment of metastatic without actionable genomic mutations, squamous non-small cell lung cancer in adults and elderly.
• Lazertinib

• Lifileucel

  • Lifileucel monotherapy for second line or later treatment of metastatic stage iv non-ALK, non-EGFR, non-ROS mutated Non-small cell lung cancer in adults and elderly who have progressed on or after chemotherapy and anti-PD-1 therapy.

• Lurbinectedin

  • Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
  • Lurbinectedin monotherapy for second line treatment of relapsed Small cell lung cancer in adults and elderly who failed one prior platinum-containing chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.
• Neladalkib
• Nibrozeton

• Nivolumab

  • Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).

• Nogapendekin Alfa Inbakicept

  • Nogapendekin alfa inbakicept in combination with pembrolizumab, carboplatin and nab-paclitaxel for first line treatment of advanced or metastatic, stage 3 or 4 Non-small cell lung cancer in adults and elderly.
• Olomorasib

• Osimertinib

  • Extension of indication to include TAGRISSO in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
  • Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA).
• Pegargiminase

• Pembrolizumab

  • Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
  • Pembrolizumab in combination with sacituzumab govitecan for first line treatment of metastatic Non-small cell lung cancer in adults and elderly with PD-L1 proportion score greater than or equal to 50%.
  • Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC).
• Pembrolizumab / berahyaluronidase alfa ^IND
• Repotrectinib

• Savolitinib

  • Savolitinib in combination with osimertinib for second line or later treatment of locally advanced or metastatic epidermal growth factor receptor mutated, MET-overexpressed and/or amplified non-small cell lung cancer in adults and elderly who have progressed on treatment with osimertinib.

• Selpercatinib

  • Selpercatinib monotherapy for adjuvant treatment of early stage (IB-IIIA) RET fusion-positive Non-small cell lung cancer in adults and elderly following definitive locoregional treatment with curative intent.

• Serplulimab

  • Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma
  • Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.
  • Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC
• Sigvotatug vedotin
• Sintilimab

• Sugemalimab

  • Cejemly in combination with platinum-based chemotherapy is indicated for the first‑line treatment of adults with metastatic non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
  • Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
• Sunvozertinib
• Taletrectinib
• Tarlatamab

• Tislelizumab

  • Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
  • Locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
  • Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1)
  • Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
  • first-line treatment in patients with unresectable, locally advanced, or metastatic non–small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DL04).

• Tremelimumab

  • Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
• Trilaciclib
• Zidesamtinib
• Zipalertinib
• Zopapogene imadenovec

Lung diseases other

• Alpha-1 antitrypsin
• Brensocatib
• Nerandomilast
• Ralinepag

• Riociguat

  • Riociguat monotherapy for treatment of Chronic thromboembolic pulmonary hypertension in children over 6 years of age and adults.

• Sotatercept

  • Treatment of pulmonary arterial hypertension.
  • Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV (see section 5.1).

• Tezepelumab

  • Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.

• Treprostinil

  • Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly.

Metabolic diseases

• Arimoclomol

  • Treatment of Niemann-Pick disease type C (NPC) in patients aged 6 months and older in combination with miglustat.
• Atidarsagene autotemcel ^IND
• BCAA-vrije aminozuren

• Burosumab

  • Crysvita is indicated for the treatment of X-linked hypophosphataemia in infants from 1 month to 1 year of age with hypophosphataemia (see section 5.1)
• Clemidsogene lanparvovec
• Coördinatieverbinding van ijzercitraat

• Dasiglucagon

  • Infants and children aged 7 days to 12 years with congenital hyperinsulinism (CHI).
• Dersimelagon
• Efzimfotase alfa

• Elamipretide

  • Elamipretide monotherapy for treatment of Barth syndrome in male adolescents, adults and elderly.
• Elinzanetant
• Encaleret
• Eneboparatide
• Garetosmab

• Govorestat

  • Sorbitol dehydrogenase deficiency.
• Hydrocortison slow-release ^IND

• L-acetylleucine

  • Aqneursa is indicated for the treatment of neurological manifestations of Niemann-Pick type C (NPC) disease, in combination with miglustat, or as a monotherapy in patients where miglustat is not tolerated, in adults and children aged 6 years and older and weighing at least 20 kg.
• Leriglitazon

• Liraglutide

  • Children (6 to <12 years): Saxenda is indicated as an adjunct to healthy nutrition and increased physical activity for weight management in children from the age of 6 to <12 years with obesity (BMI ≥95th percentile)* and body weight ≥45 kg Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. *CDC BMI cut-off points for obesity (≥95th percentile) by sex between 6 to <12 years (see table 2), in accordance with study design of the Trial 4392, see section 5.1.
• Lonapegsomatropine ^IND

• Migalastat

  • Migalastat monotherapy for treatment of Fabryʼs disease in adolescents, adults and elderly with amenable GLA variants and severe renal impairment not receiving any type of dialysis treatment.
  • Migalastat monotherapy for treatment of Fabry’s disease in adults and elderly with amenable GLA variants and end-stage renal disease who are receiving either standard hemodialysis or hemodiafiltration.

• Octreotide

  • Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

• Osilodrostat

  • Treatment of endogenous Cushing’s syndrome in adolescents and children aged 6 years and older.
• Paltusotine

• Pegvaliase

  • Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 12 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
• RGX-111
• Rebisufligene etisparvovec

• Relacorilant

  • Cushingʼs Syndrome.
• Sepiapterine

• Somapacitan

  • Sogroya is indicated for treatment of growth failure in children and adolescents in the following indications: - Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later, - Noonan syndrome (NS).

• Triheptanoin

  • Treatment of patients with Long chain fatty acid oxidation disorder (LC-FAOD).
• Venglustat

Multiple Myeloma

• Belantamab mafodotin

  • Second line treatment of r/r multiple myeloma in adults and elderly, in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone.

• Ciltacabtagene autoleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 1 prior therapy, including an IMiD and a PI, have demonstrated disease progression on or after the last therapy and are refractory to lenalidomide.

• Daratumumab

  • Daratumumab in combination with lenalidomide for maintenance treatment of newly diagnosed Multiple myeloma in adults and elderly who are minimal residual disease positive after frontline autologous stem cell transplant.

• Elranatamab

  • Voor volwassen patiënten met gerecidiveerd en refractair multipel myeloom, die tenminste drie eerdere behandelingen hebben gekregen, waaronder een immuno modulator, een proteasoom remmer en een anti CD38 antilichaam en die tijdens de laatste behandeling ziekteprogressie hebben vertoond.
  • Monotherapy for relapsed/refractory multiple myeloma patients who have received anti CD38 directed therapy and lenalidomide.
  • Monotherapy for the treatment of patients with relapsed and refractory multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor, and an immunomodulatory agent.
• Iberdomide

• Idecabtagene vicleucel

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.

• Isatuximab

  • Extension of indication to include in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
  • Isatuximab subcutaan in combinatie met pomalidomide en dexamethason voor de behandeling van volwassen patiënten met gerecidiveerd en refractair multipel myeloom (MM) die minstens twee eerdere therapieën hebben gekregen, waaronder lenalidomide en een proteasoomremmer (maar niet refractair zijn op daratumumab) en bij wie ziekteprogressie is aangetoond tijdens de laatste behandeling.
  • In combination with bortezomib, lenalidomide and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
• Linvoseltamab

• Mezigdomide

  • Mezigdomide in combination with carfilzomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have received prior treatments with lenalidomide and an anti-CD38 monoclonal antibody.
  • Mezigdomide in combination with bortezomib and dexamethasone for second line or later treatment of relapsed/refractory multiple myeloma in adults and elderly who have had prior lenalidomide exposure.

• Talquetamab

  • Talquetamab is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom die minimaal drie eerdere behandelingen hebben gekregen, waaronder een immuno-modulerend middel een proteasoomremmer en een antiCD38antilichaam. En die tijdens de laatste therapie ziekteprogressie hebben vertoond.
  • Talquetamab in combination with pomalidomide and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.
  • Talquetamab in combination with teclistamab and dexamethasone for second line or later treatment of Relapsed/refractory multiple myeloma in adults and elderly who have received an anti-CD38 antibody and lenalidomide.
  • Talquetamab in combination with daratumumab, pomalidomide and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.
  • Talquetamab in combination with daratumumab and dexamethasone for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor and lenalidomide.

• Teclistamab

  • Teclistamab monotherapy for second line or later treatment of progressive, relapsed or refractory Multiple myeloma in adults and elderly who have received an anti-CD38 monoclonal antibody and lenalidomide in any previous line.
  • Teclistamab in combination with daratumumab for second line or later treatment of relapsed or refractory Multiple myeloma in adults and elderly who have previously received a proteasome inhibitor and lenalidomide.

Multiple sclerosis

• Fenebrutinib

  • Relapsing MS
  • Primair progressieve MS (PPMS)

• Ocrelizumab

  • Pediatrische patiënten van tien jaar en ouder met relapsing remitting MS (RRMS)
• Tolebrutinib

Muscular diseases other

• Baclofen / naltrexone / sorbitol
• Condoliase
• Doxecitine / doxiribtimine
• Empasiprubart
• Iltamiocel
• Incobotulinumtoxina

• Inebilizumab

  • Uplizna is indicated as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive (see section 5.1).
• Kyv-101
• Mexiletine ^IND
• Nipocalimab
• Nomlabofusp
• Sevasemten

• Sugammadex

  • Extension of indication to include treatment the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.
• Tanruprubart
• Vatiquinone

Myeloproliferative disorders

• Bomedemstat

• Givinostat

  • Givinostat monotherapy for treatment of high-risk JAK2V617F-positive polycythaemia vera in adults and elderly.
• Pacritinib
• Pelabresib
• Pivekimab Sunirine

Neuroendocrine cancer

• Cabozantinib

  • Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.
• Lutetium (177Lu) edotreotide

• Lutetium (177Lu) oxodotreotide

  • Extension of indication to include the treatment of unresectable or metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adolescents aged 12 years and older.

• Octreotide

  • Octreotide monotherapy for first line treatment of unresectable and/or metastatic, well-differentiated gastroenteropancreatic neuroendocrine tumour disease in adults and elderly.

Neurological disorders other

• Corabotase
• Deutetrabenazine (extended release)
• Diflunisal
• Ecopipam
• Efgartigimod alfa ^IND
• Gefurulimab

• L-acetylleucine

  • Levacetylleucine monotherapy for treatment of Ataxia telangiectasia in children over 4 years of age, adolescents, adults and elderly
• Nepla-tem-cel

• Tiratricol

  • Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
• TrenibotulinumtoxinE
• Trofinetide
• Ulixacaltamide
• Zilganersen

Oncology other

• Afamitresgene autoleucel

• Belzutifan

  • WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.

• Catequentinib

  • Treatment of synovial sarcoma or leiomyosarcoma.
• Catumaxomab
• Darovasertib

• Denosumab

  • Preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen van solide tumoren. Behandeling van volwassenen en adolescenten met een volgroeid skelet met reusceltumor van het bot (‘giant cell tumour of bone’) die niet-reseceerbaar is of waarbij chirurgische resectie waarschijnlijk leidt tot ernstige morbiditeit.

• Dostarlimab

  • Dostarlimab in combination with carboplatin-paclitaxel followed by maintenance dostarlimab plus niraparib for treatment of recurrent or primary advanced Endometrial cancer in adults and elderly.
  • Dostarlimab monotherapy for first line treatment of stage ii/iii, locally advanced mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) Rectal cancer in adults and elderly.

• Durvalumab

  • Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma  (KUNLUN).
• Letetresgene autoleucel

• Methotrexaat

  • Methotrexate monotherapy for induction, consolidation, maintenance treatment of primary vitreoretinal Lymphoma in adults over 21 years of age and elderly.
• Mirdametinib
• Nirogacestat
• OST31-164

• Olaparib

  • Extension of indication for Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.
• Ozekibart

• Pembrolizumab

  • Pembrolizumab in combination with definitive chemoradiotherapy for first line treatment of oesophageal carcinoma in adults and elderly who are ineligible for curative surgery.
  • Extension of indication to include, in combination with chemotherapy with or without radiation, the adjuvant treatment of mismatch repair deficient (dMMR) endometrial cancer in adults who are at high risk of recurrence.
• Pimicotinib

• Retifanlimab

  • Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

• Selumetinib

  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).
  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.

• Serplulimab

  • Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.

• Tebentafusp

  • Tebentafusp in combination with pembrolizumab for second line or later treatment of stage III or IV unresectable HLA-A*02:01 positive non-ocular Melanoma in adults and elderly who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor.

• Toripalimab

  • Loqtorzi, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
  • Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.

• Trastuzumab

  • Extension application to introduce a new pharmaceutical form (solution for injection), a new strength (600 mg) and a new route of administration (subcutaneous use).

• Trastuzumab pamirtecan

  • Trastuzumab pamirtecan monotherapy for second line or later treatment of recurrent HER2-expressing endometrial cancer in adults and elderly previously treated with platinum-based therapy and ICI treatment.
• Vimseltinib

• Zanidatamab

  • Zanidatamab in combination with chemotherapy for first line treatment of unresectable locally advanced, recurrent or metastatic HER2-positive gastric, gastro-oesophageal junction and oesophageal adenocarcinoma in adults and elderly.
  • Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).

Other chronic immune diseases

• 13-grass pollen extract
• Allergeenextract huisstofmijt ^IND
• Atacicept
• Atrasentan

• Berotralstat

  • Berotralstat monotherapy for prophylactic treatment of hereditary angioedema in children aged 2 to 12.

• Bezuclastinib

  • Bezuclastinib in combination with best supportive care for treatment of moderate to severe nonadvanced systemic mastocytosis in adults and elderly whose symptoms are not adequately controlled.
  • Bezuclastinib monotherapy for treatment of advanced systemic mastocytosis in adults and elderly.

• Budesonide

  • Kinpeygo is indicated for the treatment of adults with a urine protein excretion-to-creatinine ratio (UPCR) ≥1,0g/dayg (or urine protein-to-creatinine ratio ≥0,8g/g).

• Crovalimab

  • Crovalimab is Indicated for Adult and Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS).
• Deucrictibant
• Donidalorsen

• Dupilumab

  • Dupixent is geïndiceerd voor de behandeling van eosinofiele oesofagitis in volwassenen, adolescenten en kinderen van een jaar en ouder. Die ongecontroleerd zijn op, intolerant zijn voor, of die geen kandidaat zijn voor conventionele therapie.

• Emapalumab

  • Treatment of acute or recurrent secondary haemophagocytic lymphohistiocytosis (sHLH) in adult and paediatric patients (6 months and older).
• Epinefrine ^IND
• Ianalumab

• Imlifidase

  • Imlifidase in combination with standard of care for treatment of severe anti-glomerular basement membrane disease in adults and elderly.

• Iptacopan

  • Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated.

• Leniolisib

  • Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.
  • Leniolisib monotherapy for treatment of Activated PI3 kinase delta syndrome in infants, toddlers and children between 1 to 12 years of age.
• Lonvoguran ziclumeran
• Marnetegragene autotemcel
• Mavorixafor

• Obinutuzumab

  • Gazyvaro in combinatie met mycofenolaatmofetil (MMF) is geïndiceerd voor de behandeling van volwassen patiënten met actieve lupus nefritis (LN) van klasse 3 of 4, met of zonder gelijktijdige klasse 5.
  • Childhood onset Idiopathic Nephrotic Syndrome (INS).

• Pegcetacoplan

  • Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

• Sarilumab

  • Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.
• Sebetralstat

• Secukinumab

  • Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents 12 years and older with an inadequate response to conventional systemic HS therapy for COSENTYX
• Sibeprenlimab
• Tadekinig alfa

• Tezepelumab

  • Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care treatment.

• Upadacitinib

  • Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
  • Treatment of severe alopecia areata (AA) in adult and adolescents 12 years and older.

Other hematology

• BGB-16673

  • Treatment of Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor

• Iopofosine I 131

  • Iopofosine i 131 monotherapy for third line or later treatment of relapsed or refractory Waldenstromʼs macroglobulinaemia in adults and elderly.
• Sargramostim

Other medication for cardiovascular diseases

• Acoramidis
• Aficamten
• Baxdrostat

• Eplontersen

  • Transthyretin amyloid cardiomyopathy (ATTR-CM).
• Etripamil

• Finerenon

  • Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.
• Fondaparinux Sodium ^BS
• Glutathione Sodium
• Lorundrostat
• Selatogrel
• Seralutinib

• Tafamidis

  • Tafamidis monotherapy for treatment of hereditary Transthyretin amyloid cardiomyopathy in adults.

• Vericiguat

  • Extension of indication for treatment of symptomatic chronic Heart failure with reduced ejection fraction in adults and elderly who have not had a recent hospitalization for heart failure or need for outpatient intravenous diuretics.

• Vutrisiran

  • Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
• Zalunfiban
• Ziltivekimab

Other metabolism and Endocrinology

• Alpelisib

  • Vijoice is indicated for the treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.
• Carbetocine
• Denatonium Acetate Monohydrate
• Diazoxide choline (controlled-release tablet)
• Ersodetug ^IND
• Estetrol

• Infigratinib

  • Infigratinib monotherapy for treatment of Achondroplasia in children over 3 years of age and adolescents.

• Linzagolix

  • Extension of indication to include treatment of endometriosis-associated pain in adult women of reproductive age.
• Navepegritide

• Pegzilarginase

  • Pegzilarginase monotherapy for treatment of Arginase 1 deficiency in newborns, infants and toddlers.

• Semaglutide

  • Extension application to introduce a new pharmaceutical form (tablet), associated with four new strengths (1,5 mg, 4 mg, 9mg and 25 mg) and a new route of administration (oral use).

• Setmelanotide

  • Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment.
• Setrusumab

• Sparsentan

  • Sparsentan monotherapy for treatment of primary and genetic Focal segmental glomerulosclerosis in children over 8 years of age, adolescents, adults and elderly.
• Tradipitant
• Xylitol/l-carnitine/glucose

Other non-oncological hematological medications

• Anselamimab

• Benralizumab

  • Fasenra is indicated as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause

• Concizumab

  • Routine prophylaxis of bleeding in patients with; haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more; haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
  • Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without FVIII inhibitors and moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤2%) without FIX inhibitors.

• Crovalimab

  • Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): - In patients with haemolysis with clinical symptom(s) indicative of high disease activity. - In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.
• Danicopan
• Denecimig
• Etavopivat
• Ferrimaltol ^IND
• Giroctocogene fitelparvovec

• Marstacimab

  • Routine prophylactic treatment of bleeding in patients twelve years and older with malignant hemophilia A and B without inhibitors.
  • Hympavzi is geïndiceerd voor routineprofylaxe van bloedingen bij patiënten van 12 jaar en ouder, met een gewicht van ten minste 35 kg, met: ernstige hemofilie A (congenitale factor VIII-deficiëntie, FVIII <1%) zonder factor VIII remmers, of ernstige hemofilie B (congenitale factor IX-deficiëntie, FIX <1%) zonder factor IX-remmers.

• Mitapivat

  • Mitapivat monotherapy for treatment of pyruvate kinase deficiency anaemia in infants and toddlers over 1 year of age, children and adolescents who are not regularly receiving blood transfusion.

• Pegcetacoplan

  • Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria who have haemolytic anaemi.
• Rilzabrutinib
• Ristoglogene Autogetemcel
• Rusfertide

Other psychiatry

• Soclenicant

Ovarian cancer

• Azenosertib

• Dostarlimab

  • Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer").
• Mirvetuximab soravtansine

• Olaparib

  • In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
• Olvimulogene nanivacirepvec

• Pembrolizumab

  • Keytruda, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PDL1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.

• Relacorilant

  • Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Senaparib

Pain

• Adezunap
• Basimglurant
• Chloroprocaine ^IND
• Cipepofol
• Sufentanil / ketamine

Pancreatic cancer

• Glufosfamide
• Zenocutuzumab

• Zolbetuximab

  • Zolbetuximab in combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma.

Parasitic infections

• Ganaplacide / lumefantrine

Parkinson's

• Levodopa / carbidopa

  • Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinsonʼs disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.

Prostate cancer

• Aglatimagene besadenovec

• Apalutamide

  • Als neo-adjuvante en adjuvante behandeling in combinatie met ADT bij mannen met hoog-risico lokaal/lokaalgevorderde prostaatkanker die een radicale prostatectomie ondergaan.

• Capivasertib

  • Extension of indication to include include Truqap in combination with abiraterone for the treatment of metastatic castration-sensitive prostate cancer characterized by PTEN deficient tumours.

• Darolutamide

  • Extension of indication to include in combination with androgen deprivation therapy (ADT) the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).

• Lutetium (177lu) vipivotide tetraxetan

  • Extension of indication to include treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after having progressed on androgen receptor pathway inhibitor (ARPI) and for whom chemotherapy is not yet clinically indicated.
• Mevrometostat
• Niraparib / abirateronacetaat ^IND
• Radium-223 ^IND

• Talazoparib

  • In combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
  • In combinatie met enzalutamide voor de eerstelijnsbehandeling van patiënten met een gemetastaseerd, hormoonsensitief HRR+ prostaatcarcinoom.

Rheumatism

• Anifrolumab

  • Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (SubQ Tulip).
  • Active Proliferative Lupus Nephritis (IRIS)
• Brepocitinib
• Dapansutrile

• Deucravacitinib

  • Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy (see section 5.1).
  • Extension of indication to include treatment of adult patients with moderate-to-severe SLE (exact indication text to be confirmed).

• Filgotinib

  • Treatment of axial spondyloarthritis in adult patients with active radiographic axial spondyloarthritis (r-axSpA) and with active non-radiographic axial spondyloarthritis (nr-axSpA).

• Golimumab

  • Golimumab-lvtc in combination with methotrexate for treatment of moderate to severe active rheumatoid arthritis in adults and elderly.

• Inebilizumab

  • Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).
• Litifilimab
• Obexelimab

• Obinutuzumab

  • Treatment of adult patients with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

• Secukinumab

  • Extension of indication to include polymyalgia rheumatica in adults whose disease has responded inadequately to, or cannot tolerate conventional therapy.

• Tofacitinib

  • Tofacitinib monotherapy for treatment of Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis, Juvenile idiopathic arthritis in children from 2 years of age and adults.

• Upadacitinib

  • Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.
  • Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
  • Upadacitinib monotherapy for treatment of moderately to severely active Systemic lupus erythematosus in adults.

SMA

• Apitegromab

• Nusinersen

  • Nusinersen monotherapy for treatment of 5q Spinal muscular atrophy in newborns, infants, toddlers, children, adolescents and adults administered at a higher dose.

• Onasemnogene abeparvovec

  • Itvisma is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older

Schizophrenia, psychosis, bipolar disorder

• BHV-7000
• Brexpiprazol ^IND
• Evenamide
• Iloperidon
• Olanzapine (long-acting injectable)

Skin cancer

• Autologous Melanoma-derived Tumor Infiltrating Lymphocytes

• Cemiplimab

  • Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

• Dabrafenib / trametinib

  • Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

• Encorafenib

  • Encorafenib in combination with binimetinib and pembrolizumab for first line treatment of metastatic or unresectable locally advanced BRAF V600E/K mutation-positive cutaneous melanoma in adults and elderly.
• Fianlimab
• Imsamotide

• Ipilimumab

  • Neo-adjuvant (off-label) treatment with ipilimumab plus nivolumab followed by adjuvant treatment in high-risk patients only.
• Nemvaleukin alfa
• Nivolumab/relatlimab/hyaluronidase Ph20
• Patidegib

• Pembrolizumab

  • Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection.
• Tucidinostat

Skin diseases

• Afamelanotide

  • Afamelanotide in combination with Narrow-Band Ultraviolet B (NB-UVB) light for treatment of stable or active generalized Vitiligo in adolescents, adults and elderly.
• Amlitelimab

• Baricitinib

  • Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older (see section 5.1).
• Beremagene geperpavec
• Clascoterone

• Delgocitinib

  • Extension of indication to include treatment of adolescents 12 years and older with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.
• Deuruxolitinib

• Dupilumab

  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.
  • Treatment of adults with bullous pemphigoid (BP).
  • Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents, and children (2 years and above) with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

• Guselkumab

  • Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy
• Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen
• Icotrokinra
• Imsidolimab

• Lebrikizumab

  • Lebrikizumab in combination with topical corticosteroid for treatment of moderate to severe atopic dermatitis in infants, toddlers over 6 months, children and adolescents.
• Nemolizumab

• Povorcitinib

  • Voor de behandeling van actieve matige tot ernstige hidradenitis suppurativa (HS) bij volwassenen met een ontoereikende respons op conventionele systemische hidradenitis suppurativa therapie.
  • Vitiligo
  • Prurigo nodularis (PN)
• Prademagene zamikeracel
• Remibrutinib

• Risankizumab

  • Extension application to include treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

• Ritlecitinib

  • Treatment of patients with non-segmental vitiligo.

• Ruxolitinib (als fosfaat)

  • Prurigo nodularis (PN).
  • Extension of indication to include treatment of moderate atopic dermatitis in adult patients who are inadequately controlled with, have a contraindication to, or are intolerant to topical corticosteroids and topical calcineurin inhibitors.
• Ruxolitinib als fosfaat ^IND
• Tirbanibuline ^IND

• Upadacitinib

  • Non-segmental Vitiligo in adolescents, adults and elderly who are eligible for systemic therapy.
• Zasocitinib

Sleep disorders

• Lemborexant
• Oveporexton

Stem cell transplants

• Dorocubicel
• Etuvetidigene autotemcel
• Narsoplimab

Stomach cancer

• Bezuclastinib

  • Tweedelijnsbehandeling van lokaal gevorderde, gemetastaseerde en/of niet-reseceerbare PDGFR-negatieve gastro-intestinale stromale tumor bij volwassenen en ouderen zonder succinaat dehydrogenasedeficiëntie en die eerder alleen met imatinib zijn behandeld, behandeling in combinatie met sunitinib.

• Durvalumab

  • Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC). Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

• Sugemalimab

  • Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma.

• Tislelizumab

  • Extension of indication to include in combination with platinum-based chemotherapy the first-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC).
  • Extension of indication to include in combination with platinum and fluoropyrimidine-based chemotherapy the first-line treatment of adult patients with human epidermal growth factor receptor-2 (HER-2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

• Trastuzumab deruxtecan

  • Trastuzumab deruxtecan (T-DXd) in patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DG04).
  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Thyroid cancer

• Dabrafenib / trametinib

  • Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).

• Selpercatinib

  • Retsevmo as monotherapy is indicated for the treatment of paediatric patients 12 years of age and older with: advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate); advanced RET-mutant medullary thyroid cancer (MTC); advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted. For biomarker-based patient selection.

Tumour agnostic medication

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options

Viral infections other

• Baloxavir marboxil

  • Extension of the indication to include the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 3 weeks and older.
• Bepirovirsen
• Cantharidin
• Clesrovimab

• Glecaprevir / pibrentasvir

  • Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older
• Pritelivir

Unknown

• Amisulpride ^G
• Colistimethaatnatrium ^IND
• Emactuzumab

• Etelcalcetide

  • Etelcalcetide in combination with standard of care for treatment of Hyperparathyroidism secondary in infants and toddlers, children and adolescents with chronic kidney disease receiving maintenance hemodialysis.

• Human normal immunoglobulin

  • Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or not advised. Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.
• Ivospemin
• Mirabegron ^IND
• Molgramostim

• Pembrolizumab

  • Pembrolizumab monotherapy in dMMR advanced or recurrent endometrial carcinoma.