Published on 3 June 2025

ADHD

• Guanfacine ^G

ALL

• Blinatumomab

  • Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor 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).
• Obecabtagene autoleucel

• Ponatinib

  • 1L Philadelphia positieve ALL

ALS

• Gold Nanocrystals
• Lenzumestrocel

• Masitinib

  • Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.

• Pridopidine

  • Amyotrophic lateral sclerosis (ALS)
• Tofersen

AML / MDS

• Imetelstat
• Iodine (131I) apamistamab
• Olutasidenib
• Revumenib
• Tamibarotene
• 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).

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

• Crizotinib

  • Treatment of paediatric patients (age ≥1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)‑positive anaplastic large cell lymphoma (ALCL) and the treatment of paediatric patients (age ≥1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK)‑positive unresectable inflammatory myofibroblastic tumour (IMT).

• Epcoritamab

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

• Glofitamab

  • Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
  • Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

• Lisocabtagene maraleucel

  • Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

• Loncastuximab tesirine

  • Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
  • 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.

• Polatuzumab vedotin

  • Polivy in combinatie met rituximab, cyclofosfamide, doxorubicine en prednison (R-CHP) is geïndiceerd voor de behandeling van volwassen patiënten met niet eerder behandeld diffuus grootcellig B-cellymfoom (DLBCL).

• Tafasitamab

  • MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
  • 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 grootcellig B-cellymfoom (DLBCL).

Antithrombotic medications

• Apixaban

  • Extension to the existing indication to include treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children, associated with the addition of new pharmaceutical forms and new strengths (0.15mg granules in capsules for opening, as well as 0.5mg, 1.5mg and 2mg coated granules in sachet).
• Edaravone / dexborneol

Asthma

• Depemokimab

• Formoterol / glycopyronium / budesonide

  • Aanvullende onderhoudsbehandeling voor volwassenen met ongecontroleerde chronische obstructieve astma Budesonide/glycopyrronium/formoterol monotherapie voor de behandeling van onvoldoende gecontroleerde astma bij adolescenten, volwassenen en ouderen.

Bacterial infections

• Amikacine ^IND
• Ceftobiprole medocaril
• Contezolid

• Dalbavancine

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

• Eravacycline

  • Eravacycline monotherapy for treatment of Complicated intra-abdominal infection in children and adolescents.
• Faecal microbiota transplant
• Gepotidacin

• Imipenem / Cilastatin / Relebactam

  • Imipenem/cilastatin/relebactam monotherapy for treatment of gram-negative Bacterial infection in newborns, infants, toddlers, children and adolescents with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, complicated intra-abdominal infection, or complicated urinary tract infection.

• 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

  • Extension of indication to include in combination with bedaquiline, linezolid and moxifloxacin the treatment of adults with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to rifampicin, with or without resistance to isoniazid
• Ridinilazole
• Sulopenem
• Tebipenem

• Tedizolid

  • Extension of the indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) for adults, adolescents and children weighing at least 35 kg.

• Vonoprazan

  • Patients with Helicobacter pylori infection.
• Zoliflodacin

Bladder cancer

• Durvalumab

  • Durvalumab (Imfinzi) in combination with Bacillus Calmette-Guérin (BCG) therapy in patients with high-risk, BCG-naïve, non-muscle invasive bladder cancer (NMIBC). (POTOMAC)
  • 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).
  • 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.

• Erdafitinib

  • Erdafitinib voor de behandeling van volwassen patiënten met een lokaalgevorderd, niet-reseceerbaar of gemetastaseerd urotheelcelcarcinoom met specifieke genetische afwijkingen in FGFR3 en ziekteprogressie tijdens of na tenminste 1 PD-(L)1 remmer-bevattende behandellijn.
• Mitomycine extended release
• Nogapendekin alfa

• 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.

• Sacituzumab Govitecan

  • Latere lijnsbehandeling van gemetastaseerd urotheelcarcinoom.
• Sasanlimab

Bowel diseases

• Apraglutide

• Etrasimod

  • Velsipity is geïndiceerd voor de behandeling van patiënten van 16 jaar en ouder met matig tot ernstig actieve colitis ulcerosa (CU) die onvoldoende reageren of niet meer reageren op of intolerant zijn voor conventionele behandeling of een biologisch middel.
• Glepaglutide

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

• Hydrocortison

  • Hydrocortisone monotherapy for treatment of active rectum Ulcerative colitis in adults and elderly.
• Ivarmacitinib

• Mirikizumab

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

• Risankizumab

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

• Teduglutide

  • Treatment of Short Bowel Syndrome

• Ustekinumab

  • STELARA is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

Brain cancer

• Berubicin
• Dordaviprone
• Eflornithine ^IND
• Paclitaxel trevatide
• Temozolomide ^IND
• Vorasidenib

Breast cancer

• Abemaciclib

  • Verzenios is, in combinatie met endocriene therapie, geïndiceerd voor de adjuvante behandeling van volwassen patiënten met hormoonreceptor (HR)-positieve, humane epidermale groeifactorreceptor 2 (HER2)-negatieve, klierpositieve vroege borstkanker met een hoog risico op recidief.

• Camizestrant

  • Camizestrant in combination with CDK4/6 inhibitors for add-on treatment of locoregionally recurrent or metastatic ER-positive, HER2-negative, ESR1-positive Breast cancer in adults and elderly. (SERENA-6).
  • 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

  • Datopotamab deruxtecan as monotherapy is indicated for the treatment of adult patients with locally recurrent inoperable 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 iDatroway 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
• Db-1303/bnt323
• Elacestrant

• 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
• 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.

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.

• 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 or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

• 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.
  • Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DB05).
  • Trastuzumab deruxtecan (Enhertu) with or without pertuzumab compared to standard of care in patients with HER2-positive metastatic breast cancer (DB09).

• Tucatinib

  • Maintenance treatment of unresectable locally advanced or metastatic HER2 positive breast cancer.

CLL

• Acalabrutinib

  • Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

• 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.

• Zanubrutinib

  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL).
  • Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy

CML

• Asciminib

  • Asciminib monotherapy for first line treatment of Philadelphia chromosome-positive Chronic phase chronic myeloid leukemia in adults and elderly.
  • Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) harbouring the T315I mutation.

• 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.

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.
• Ensifentrine
• Itepekimab

• Mepolizumab

  • Extension of indication to include treatment of Chronic Obstructive Pulmonary Disease (COPD)

COVID-19

• Bio101

• Casirivimab / imdevimab

  • Extension of the indication to include the treatment of pediatric patients from 2 to less than 12 years of age, weighing at least 10 kg, who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19 for Ronapreve.

• Ensitrelvir

  • Ensitrelvir monotherapy for the treatment of mild and moderate COVID-19 in non-hospitalised adults and the elderly.
  • Ensitrelvir monotherapy for the preventive treatment of symptomatic SARS-CoV-2 infection in children, adolescents, adults and the elderly who are household contacts of a person with symptomatic COVID-19.
• 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)
• Sabizabulin
• Sipavibart
• Vilobelimab

Cardiovascular diseases

• Secukinumab

  • Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly.

Cervical cancer

• Cadonilimab
• Hexaminolevulinate hydrochloride

• Pembrolizumab

  • Keytruda, in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy), is indicated for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer in adults who have not received prior definitive therapy
• Tisotumab vedotin

Colon cancer

• Encorafenib

  • Encorafenib in combination with cetuximab and chemotherapy for first line treatment of stage IV metastatic BRAF V600E-mutant Colorectal cancer in adolescents over 16 years of age, adults and elderly.
• Fruquintinib

• 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.
• Pembrolizumab / favezelimab

• 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 ^IND
• Vanzacaftor / tezacaftor / deutivacaftor ^IND

Dementia

• Blarcamesine
• Donanemab
• Hydromethylthionine mesylaat
• Lecanemab
• Valiltramiprosate

Depression

• Zuranolone

Diabetes

• Canagliflozine

  • Extension of indication to include treatment of paediatric patients with type 2 diabetes mellitus aged 10 years old and older

• Dasiglucagon

  • Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.
• Empagliflozine / metformine ^IND
• Glibenclamide ^IND
• Insulin icodec / semaglutide
• Regulatoire T-cellen (TREGS)
• Teplizumab

Duchenne

• Delandistrogene moxeparvovec
• Deramiocel
• Fordadistrogene movaparvovec

• 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

Epilepsy

• Diazepam nasaal
• Midazolam ^IND
• Zonisamide ^IND

Eye disorders

• Acoltremon

• Aflibercept

  • Aflibercept monotherapy for first line treatment of Macular oedema in adults and elderly secondary to retinal vein occlusion.
• Atropine sulfate ^IND
• Bevacizumab-vikg ^BS
• Botaretigene sparoparvovec
• Brimonidine tartrate/carbachol

• Faricimab

  • Extension of indication to include treatment of adult patients with visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
• IBI311
• Laruparetigene zosaparvovec

• Mercaptamine

  • Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.
• Midazolam/ketamine
• OCU400
• Polihexanide

• Ranibizumab

  • Treatment of neovascular age-related macular degeneration (AMD).
• Ripasudil
• Tarcocimab tedromer
• Teprotumumab
• Timbetasine acetaat
• Varenicline
• Veligrotug

Fungal infections

• Isavuconazole

  • Cresemba hard capsules are indicated in adults and paediatric patients aged 6 years and older for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is not suitable.
• Miconazole
• Olorofim

Graft versus Host

• Belumosudil
• MaaT013

• Ruxolitinib

  • Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.

HIV

• Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide

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

• Darunavir / cobicistat

  • Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients (aged 6 years and older, weighing at least 25 kg).
• Emtricitabine/tenofovir alafenamide ^G

• Lenacapavir

  • Lenacapavir monotherapy for the prophylactic treatment of HIV infection in adolescents over 16 years of age, adults and the elderly.
• Pitavastatine

• Rilpivirine

  • Rekambys in combination with cabotegravir injection is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen with no current or previous evidence of viral resistance to, and no previous virologic failure with, non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase inhibitors (INIs) classes.

Head and neck cancer

• Buparlisib
• Cetuximab sarotalocan

• Leukocyte interleukin

  • Cancer of the oral cavity, neoadjuvant

• Pembrolizumab

  • Pembrolizumab in combination with standard of care radiotherapy for neoadjuvant, adjuvant treatment of newly diagnosed stage III/IVA, resectable, locoregionally advanced Squamous cell carcinoma of head and neck in adults and elderly.

• Tislelizumab

  • Extension of indication to include, in combination with gemcitabine and cisplatin, the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

Headache

• Atogepant

  • Acute Migraine in adults and elderly

• Eptinezumab

  • Eptinezumab monotherapy for preventive treatment of Chronic migraine in children over 6 years of age and adolescents with or without aura.

• Fremanezumab

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

Hemostasis promoting medication

• Damoctocog alfa pegol

  • Treatment and prophylaxis of bleeding in previously treated patients ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency)
• Etranacogene dezaparvovec
• Fidanacogene elaparvovec

• 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

  • Vonicog alfa monotherapy for prophylactic treatment of severe type 1, type 2 or type 3 Von Willebrand's disease in infants, toddlers, children and adolescents

Hodgkin's lymphoma

• Brentuximab vedotin

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

• Tislelizumab

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

Indolent non-Hodgkin’s lymphoma

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

• 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.

• 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.

• Mosunetuzumab

  • Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy.

• Tafasitamab

  • Toevoeging van tafasitamab aan lenalidomide en rituximab bij patiënten met recidiverend of refractair folliculair lymfoom (R/R FL)

• Zanubrutinib

  • Brukinsa in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Infectious diseases other

• Cefepime/taniborbactam

Kidney cancer

• Belzutifan

  • 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.

• Cabozantinib

  • Cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced or metastatic renal cell carcinoma.
• Nivolumab/hyaluronidase Ph20 ^IND

• 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

• Bempedoic acid / ezetimibe

  • Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk.
• Enlicitide decanoate

• Evinacumab

  • Extension of indication for EVKEEZA to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia aged 6 months to less than 5 years

• Inclisiran

  • Behandeling van pediatrische patiënten van 6 jaar en ouder met heterozygote familiaire hypercholesterolemie (HeFH) of homozygote familiaire hypercholesterolemie (HoFH).

• Lerodalcibep

  • Heterozygous Familial Hypercholesterolemia
  • 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
• Pelacarsen
• Pravastatine / ​fenofibraat ^IND

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 combination with tremelimumab 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.
• 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

• 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

• Elafibranor

• Maralixibat

  • Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older.

• Odevixibat

  • Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older.
• Resmetirom
• Seladelpar

• Semaglutide

  • Treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis with liver fibrosis

Lung cancer

• Alectinib

  • Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK‑positive NSCLC at high risk of recurrence.

• Amivantamab

  • Amivantamab in combination with carboplatin and pemetrexed for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations.
  • 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.

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
  • Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
  • In combinatie met lurbinectedine als onderhoudsbehandeling in de eerste lijn voor uitgebreid stadium kleincellig longkanker (ES-SCLC).
  • Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy.
• Aumolertinib (mesilate)
• Ceralasertib
• Cobolimab

• Datopotamab deruxtecan

  • Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer, who have received at least one systemic therapy.

• Domvanalimab

  • first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

• 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 (for selection criteria, see section 5.1).

• Encorafenib

  • Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
• Ensartinib
• Furmonertinib

• Ivonescimab

  • First line treatment of stage IIIB / C or IV locally advanced or metastatic PD-L1-positive nonsmall cell lung cancer in adults and elderly with no EGFR-sensitive mutations or ALK gene translocations.
• Lazertinib

• Lenvatinib

  • Advanced or Recurrent Non Small Cell Lung Cancer (1L, non squamous) in combination with pembrolizumab.

• Lurbinectedin

  • Small cell lung cancer (SCLC).
• 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).
• Ociperlimab

• Osimertinib

  • Extension of indication to include treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy.
  • Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
  • 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).
• Patritumab deruxtecan
• 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 / berahyaluronidase alfa ^IND
• Pembrolizumab / vibostolimab
• Repotrectinib

• Retifanlimab

  • Lokaal gevorderd of gemetastaseerd stage IV niet-kleincellige longkanker eerste lijn.

• Sacituzumab Govitecan

  • Latere lijns gemetastaseerde Non Small Cell Lung Cancer, voorbehandeld met immunotherapie en chemotherapie.
• Savolitinib

• Serplulimab

  • Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly.

• 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.
• Sunvozertinib
• Tarlatamab

• Tiragolumab

  • Tiragolumab in combination with Atezolizumab for first line treatment of locally advanced unresectable or metastatic high PD-L1, EGFR-negative, ALK-negative Non-small cell lung cancer in adults and elderly.
  • In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy.

• 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.
  • Extension of indication for Tevimbra in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable NSCLC.
  • 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.
• Zopapogene Imadenovec

Lung diseases other

• Benralizumab

  • Extension of indication to include treatment of eosinophilic granulomatosis.
  • Patiënten met ernstige bilaterale neuspoliepen die nog steeds symptomatisch zijn ondanks de standaardbehandeling, dat wil zeggen het huidige gebruik van intra-nasale corticosteroïden (INCS) en eerdere chirurgie en/of het gebruik van systemische corticosteroïden.
• Brensocatib

• Ciclosporine

  • Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndrome in adults and the elderly after lung transplantation.
• Efzofitimod ^G
• Exoflo Extracellular Vesicles
• Nerandomilast

• Nintedanib

  • Ofev is indicated in children and adolescents aged 6 to 17 years for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs)
• Pamrevlumab

• Riociguat

  • Adempas is indicated for the treatment of PAH in paediatric patients aged 6 to less than 18 years with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists (see section 5.1).

• Sotatercept

  • Treatment of pulmonary arterial hypertension.

• Tezepelumab

  • Chronic rhinosinusitis with nasal polyps (CRSwNP)

Metabolic diseases

• Aminozuren
• Atidarsagene autotemcel ^IND
• Avalglucosidase alfa
• Cipaglucosidase alfa
• Clemidsogene lanparvovec
• Coördinatiecomplex van ijzercitraat
• Crinecerfont

• Dasiglucagon

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

• Elamipretide

  • Elamipretide monotherapy for treatment of primary Mitochondrial myopathy in adults and elderly with pathogenic nuclear DNA mutations.
• Eliglustat ^IND
• Elinzanetant
• Encaleret
• Eneboparatide

• Govorestat

  • Patients with Classic Galactosaemia aged 2 to 65 years.
  • Sorbitol dehydrogenase deficiency
• Leriglitazon
• Leriglitazone

• 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.

• Migalastat

  • Migalastat monotherapy for treatment of Fabry's 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.
• N-Acetyl-L-Leucine
• Nedosiran

• Octreotide

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

• Olezarsen

  • Olezarsen monotherapy for add-on treatment of severe hypertriglyceridemia in adults and elderly.
• Paltusotine
• Pegunigalsidase alfa

• Pegvaliase

  • Pegvaliase monotherapy for treatment of Phenylketonuria in adolescents.
• Plozasiran
• Rebisufligene etisparvovec

• Relacorilant

  • Cushing's Syndrome
• Sepiapterin

• Somatrogon

  • Somatrogon monotherapy for treatment of growth hormone deficiency in adults.
• Tiomolibdate choline
• 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

  • Extension of indication for Darzalex in combination with bortezomib, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma, to include also adult patients who are not eligible for stem cell transplant (SCT).
  • Extension of indication to include daratumumab for the treatment of adult patients with smouldering multiple myeloma (SMM) at high risk of developing multiple myeloma.

• Elranatamab

  • Elrexfio is geïndiceerd voor volwassen patiënten met gerecidiveerd en refractair multipel myeloom, die ten minste drie eerdere behandelingen hebben gekregen, waaronder een immunomodulator, een proteasoomremmer en een anti-CD38-antilichaam, en die tijdens de laatste behandeling ziekteprogressie hebben vertoond.

• 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 in combination with pomalidomide and dexamethasone for second line or later treatment of relapsed and/or refractory multiple myeloma in adults and elderly who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
  • In combination with bortezomib, lenalidomide and dexamethasone (Isa VRd) in patients with newly diagnosed multiple myeloma (NDMM) eligible for transplant.
• Linvoseltamab

• Selinexor

  • In combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die tenminste één eerdere therapie hebben ondergaan.

• Talquetamab

  • Talquetamab is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom die minimaal 3 eerdere behandelingen hebben gekregen, waaronder een immunomodulerend middel een proteasoomremmer en een antiCD38antilichaam. En die tijdens de laatste therapie ziekteprogressie hebben vertoond.

Multiple sclerosis

• Tolebrutinib

• Ublituximab

  • Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features

Muscular diseases other

• ANX-005
• Baclofen / naltrexone / sorbitol
• Bidridistrogene xeboparvovec
• Doxecitine / doxiribtimine

• Inebilizumab

  • Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or anti-MuSK antibody.
• Mexiletine ^IND
• Nipocalimab
• Omaveloxolon
• Rozanolixizumab

• 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.
• Vatiquinone
• Zilucoplan

Myeloproliferative disorders

• Avapritinib

  • Advanced systemic mastocytosis (AdvSM). AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.
• Peginterferon alfa-2a ^IND
• Pelabresib

• Pemigatinib

  • Extension of indication to include treatment of adults with myeloid/lymphoid neoplasms (MLNs) with Fibroblast Growth Factor Receptor1 (FGFR1) rearrangement.

Neuroendocrine cancer

• Cabozantinib

  • Extension of indication to include the treatment of adult patients with progressive extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours after prior systemic therapy.
• Lutetium (177Lu) edotreotide

• Lutetium (177Lu) oxodotreotide

  • Extension of indication to include the treatment of newly diagnosed, unresectable or metastatic, well-differentiated (G2 and G3), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients.
  • 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

Neurological disorders other

• Deutetrabenazine (Extended release)
• Diflunisal
• Ecopipam
• Efgartigimod alfa / hyaluronidase-qvfc ^IND
• Eplontersen
• Nepla-tem-cel

• Pridopidine

  • Early stage Huntington Disease

• Tiratricol

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

• Vutrisiran

  • Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

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

  • Catequentinib monotherapy for first line, second line treatment of unresectable, locally advanced or metastatic Alveolar soft part sarcoma in adults and elderly.
• 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

  • Extension of indication for JEMPERLI to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
  • Extension of indication to include in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability high (MSI H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.

• Durvalumab

  • Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer​ who are candidates for systemic therapy, followed by maintenance treatment with: - combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). (DUO-E)
  • monotherapy in endometrial cancer that is mismatch repair deficient (dMMR).
• Efbemalenograstim alfa

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult and pediatric patients older than 1 month with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment option.
• Letetresgene autoleucel
• Melphalan hydrochloride
• Mirdametinib
• Nirogacestat

• 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.
• Onfekafusp Alfa
• Ozekibart

• Pembrolizumab

  • Keytruda, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.
• Pimicotinib

• Retifanlimab

  • Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal (squamous cell anal cancer (SCAC)), 1L (ODD) (+CT).

• Selinexor

  • Maintenance with selinexor after combination chemotherapy for patients with advanced or recurrent endometrial cancer.

• Selumetinib

  • Selumetinib monotherapy for first line treatment of symptomatic inoperable plexiform neurofibroma in adults and elderly with neurofibromatosis type 1.

• 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 pamirtecan
• Varegacestat
• 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
• Arachis hypogaea (pinda) allergenen ^IND
• Atrasentan
• Briquilimab

• 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).
• Coacillium topical
• Donidalorsen

• Dupilumab

  • Dupixent is geïndiceerd voor de behandeling van eosinofiele oesofagitis in volwassenen, adolescenten en kinderen van 1 jaar en ouder. Die ongecontroleerd zijn op, intolerant zijn voor, of die geen kandidaat zijn voor conventionele therapie.
  • 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.
• Epinephrine
• Garadacimab

• 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.
• Lanalumab

• Leniolisib

  • Behandeling van Geactiveerd PI3 Kinase Delta-Syndroom (APDS) bij volwassenen en adolescenten van 12 jaar en ouder.
• Lorecivivint
• Marnetegragene autotemcel

• Masitinib

  • Masitinib in combination with best supportive care for third line or later treatment of severe Indolent systemic mastocytosis and of for the treatment of severe smouldering Systemic mastocytosis i in adults and elderly who are unresponsive to optimal symptomatic treatment.
• Mavorixafor
• Mycofenolaatmofetil ^IND

• Obinutuzumab

  • Lupus Nephritis

• Pegcetacoplan

  • Adolescents aged 12 years or older and adults who have C3 glomerulonefritis glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN) or a recurrence of their disease in a transplant kidney.

• Ritlecitinib

  • Litfulo is geïndiceerd voor de behandeling van ernstige alopecia areata bij volwassenen en adolescenten van 12 jaar en ouder.

• 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-bthr ^BS
• Sibeprenlimab

• 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.
  • Severe Alopecia areata in adolescents and adults.

Other medication for cardiovascular diseases

• Acoramidis
• Baxdrostat
• Etripamil

• Finerenon

  • Extension of indication to include the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.
• Glutathione Sodium

• Mavacamten

  • Mavacamten for treatment of symptomatic (NYHA class II or III) non-obstructive hypertrophic cardiomyopathy in adults.
• Neoatricon (dopamine)

• Rilonacept

  • Treatment of idiopathic pericarditis.
• Seralutinib

• Tirzepatide

  • Extension of indication to include treatment of symptomatic chronic heart failure with preserved ejection fraction (HFpEF) in adults with obesity.

• Vutrisiran

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

Other metabolism and Endocrinology

• Alpelisib

  • PIK3CA-Related Overgrowth Spectrum (PROS). PROS omvat de onderstaande syndromen: - Goedaardige lichenoïde keratose (BLK) - Dysplastische megalencefalie (DMEG) - CLOVES (aangeboren lipomateuze overgroei, vasculaire malformatie, epidermal naevi-syndroom) - Epidermal naevi (EN) - Fibro-adipeuze overgroei (FAO) - Hemimegalencefalie (HMEG) - Hemihyperplasie - meervoudige lipomatose (HHML) geïsoleerde grote lymfatische malformatie (ILM) - Megaencefalie- capillaire malformatie (MCAP) - Muscular hemihyperplasia (mHH) - Seborrhoïsche keratose (SK)
• Autologous human chondrocytes in vitro expanded
• Estetrol

• Etelcalcetide

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

• Linzagolix

  • Extension of indication to include treatment of endometriosis-associated pain in adult women of reproductive age.
• Navepegritide
• Relugolix / estradiol / norethisterone acetaat ^IND

• Semaglutide

  • Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2.
  • Op dit moment heeft oraal semaglutide reeds een indicatie voor diabetes. De aan te vragen indicatieuitbreiding zal slaan op het behandelen van obesitas.

• Setmelanotide

  • Extension of indication to include the population of children aged 2 years and above for the treatment of pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin Type 1 (PCSK1) deficiency or biallelic leptin receptor (LEPR) deficiency and Bardet-Biedl Syndrome (BBS) for IMCIVREE.
  • Setmelanotide monotherapy for treatment of acquired hypothalamic obesity in children over 4 years of age, adolescents, adults and elderly.
• Setrusumab

• Tirzepatide

  • Uitbreiding van de indicatie: voor gewichtsbeheersing bij volwassenen met obesitas of overgewicht met gewicht gerelateerde co-morbide aandoeningen.
• Xylitol/l-carnitine/glucose

Other non-oncological hematological medications

• Apadamtase alfa
• Aprocitentan

• Benralizumab

  • Hypereosinofiel syndroom (HES)

• 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.
• Crovalimab
• Danicopan
• Efanesoctocog alfa ^IND

• Eltrombopag

  • Extension of indication to include second-line treatment of paediatric patients aged 2 years and above with acquired severe aplastic anaemia (SAA).
• Exagamglogene autotemcel
• Giroctocogene fitelparvovec
• Inclacumab

• Iptacopan

  • Treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) to treat haemolytic anaemia.

• Marstacimab

  • Routinematige profylactische behandeling van bloedingen bij patiënten 12 jaar en ouder met ernstige hemofilie A en B zonder remmers
• Mim 8

• Mitapivat

  • Treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassaemia
  • 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.
• Mozafancogene autotemcel

• Pegcetacoplan

  • Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemi.
• Pozelimab
• Rilzabrutinib
• Rusfertide

Ovarian cancer

• Catequentinib

  • Catequentinib in combination with background chemotherapy for third line or later treatment of recurrent or metastatic cervical cancer, endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinosarcoma in adults and elderly.

• 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).

• Pembrolizumab

  • Pembrolizumab in combination with paclitaxel with or without bevacizumab for second line or later treatment of platinum-resistant Ovarian cancer recurrent in adults and elderly.
  • Pembrolizumab in combination with carboplatin/paclitaxel chemotherapy with or without bevacizumab followed by pembrolizumab+olaparib maintenance for first line treatment of stage III or IV BRCA non-mutated Fallopian tube cancer, Ovarian epithelial cancer, Primary peritoneal carcinosarcoma in adults and elderly.

• Relacorilant

  • Relacorilant in combination with nab-paclitaxel for second line or later treatment of advanced platinum-resistant, high-grade serous fallopian tube cancer, ovarian epithelial cancer, primary peritoneal carcinosarcoma in adults and elderly.

Pain

• Adezunap
• Basimglurant
• Chloroprocaine ^IND

Pancreatic cancer

• Gemcitabine ^IND
• Glufosfamide
• Zenocutuzumab

Parkinson's

• Levodopa / carbidopa

  • Levodopa/carbidopa monotherapy for treatment of Parkinson's disease in adults over 30 years of age and elderly who are experiencing motor fluctuations

Prostate cancer

• 177Lu-PNT2002

• Atezolizumab

  • In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT).

• Capivasertib

  • Capivasertib is indicated in combination with abiraterone as treatment for patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency.

• Darolutamide

  • Nubeqa is indicated for the treatment of adult men with metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy.
  • 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

  • Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
• Mevrometostat

• Niraparib / abirateron

  • In combinatie met predniso(lo)n en ADT voor de behandeling van mannen met mHSPC en afwijkingen in genen betrokken bij het herstel van DNA via homologe recombinatie (HRR+ mHSPC).
  • Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer.
• Radium-223 ^IND
• Rosopatamab tetraxetan lutetium (177Lu)

• Rucaparib

  • Treatment of metastatic castration resistant prostate cancer (CRPC) associated with a deleterious alteration in either the BRCA1, BRCA2 or ATM genes.

• Talazoparib

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

Rheumatism

• Anifrolumab

  • Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (SubQ Tulip).

• Bimekizumab

  • Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
  • Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
• Dapansutrile

• Emapalumab

  • Emapalumab monotherapy for treatment of glucocorticoid-refractory Macrophage activation syndrome in infants, toddlers over 6 months of age, children, adolescents, adults and elderly with Still's Disease.

• Filgotinib

  • Axial spondyloarthritis
• Golimumab ^BS

• Inebilizumab

  • Uplizna is indicated for the treatment of adult patients with IgG4-RD.

• Ixekizumab

  • Ixekizumab monotherapy for treatment of active enthesitis-related or psoriatic juvenile idiopathic arthritis in children and adolescents.
• Lingolinurad
• Litifilimab

• Sarilumab

  • Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.

• Secukinumab

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

• Upadacitinib

  • Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.

SMA

• Apitegromab

• Onasemnogene abeparvovec

  • Patients up to 18 years of age with 5q spinal muscular atrophy (SMA) SMA type 1, 2 and 3 or with 1-4 copies of the SMN2-gene.

Schizophrenia, psychosis, bipolar disorder

• Brexpiprazol ^IND
• Cycloserine / lurasidon
• Olanzapine (long-acting injectable)
• Roluperidon
• Xanomeline / trospium

Skin cancer

• Cemiplimab

  • Cemiplimab monotherapy for adjuvant treatment of high-risk Cutaneous squamous cell carcinoma in adults and elderly who have completed surgery and post-operative RT radiation therapy.
• Cosibelimab
• Daromun

• 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.
• IO102-IO103

• Ipilimumab

  • Neo-adjuvant (off-label) treatment with ipilimumab plus nivolumab followed by adjuvant treatment in high-risk patients only.

• Lifileucel

  • Lifileucel in combination with pembrolizumab and follow-on IL-2 for first line or later treatment of metastatic stage IIIc, IIId, or IV unresectable melanoma in adults and elderly following lymphodepletion regimen.
  • Lifileucel in combination with follow-on IL-2 for second line treatment of stage IIIc/IV unresectable or metastatic Melanoma in adults and elderly.
• Nemvaleukin alfa ^IND
• Nivolumab/relatlimab/hyaluronidase Ph20
• Relatlimab / nivolumab
• Resminostat
• 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.

• Apremilast

  • Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap.
• Beremagene geperpavec

• Bimekizumab

  • Extension of indication to include treatment of moderate to severe hidradenitis suppurativa (HS) in adults.
• Clascoterone
• Dabocemagene autoficel
• Deuruxolitinib
• Dipalmitoyl Hydroxyproline

• Dupilumab

  • Dupilumab in combination with oral corticosteroids for treatment of Bullous pemphigoid in adults and elderly.

• Guselkumab

  • Extension of indication 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.
• 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.
  • Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40kg who are candidates for systemic therapy.
• Nemolizumab
• Piclidenoson
• Prademagene zamikeracel
• Remibrutinib

• Risankizumab

  • Voor de behandeling van adolescenten (12 en jonger dan 18 jaar) patiënten met matige tot ernstige psoriasis en een gewicht hoger dan 40kg. Voor de behandeling van pediatrische (6 en jonger dan 18 jaar) patiënten met matige tot ernstige psoriasis en gewicht lager dan 40kg.

• Roflumilast topicaal

  • Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age.

• Ruxolitinib (als fosfaat)

  • Volwassenen met matige atopische dermatitis die eerder zijn behandeld met topische corticosteroïden of topische calcineurine remmers of waarbij deze middelen zijn gecontra-indiceerd.

• Tildrakizumab

  • Tildrakizumab monotherapy for treatment of active psoriatic arthritis in adults and elderly who have prior exposure to anti-tumor necrosis factor agent.
  • Tildrakizumab monotherapy for treatment of active Psoriatic arthritis in adults and elderly who have no prior exposure to anti-tumor necrosis factor agent.
• Tirbanibulin
• Tirbanibuline ^IND

• Upadacitinib

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

Sleep disorders

• Melatonine

  • Extension of indication for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

• Tasimelteon

  • Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS).

• Tirzepatide

  • Extension of indication to include, as an adjunct to diet and exercise, the treatment of moderate to severe obstructive sleep apnoea (OSA) in adults with obesity.

Stem cell transplants

• Dorocubicel
• Nomacopan

Stomach cancer

• Bezuclastinib

• Durvalumab

  • Neoadjuvant-Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC). (Matterhorn)
  • Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma  (KUNLUN).
• Ripretinib

• 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.
• Zolbetuximab

Tumour agnostic medication

• MDM2-p53 antagonist

• Selpercatinib

  • Extension of indication for Retsevmo to include the treatment of adults with advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.

• Trastuzumab deruxtecan

  • Patients With HER2-Expressing Solid Tumors.

Unknown

• ARINA-1
• Atacicept
• Colistimethate Sodium ^IND
• Diazoxide choline (controlled-release tablet)

• 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.
• Lonapegsomatropine ^IND
• Mirabegron ^IND

• Olezarsen

  • Olezarsen monotherapy for add-on treatment of severe familial chylomicronemia syndrome in adults and elderly
• Tadekinig Alfa
• Tanimilast
• Vibegron

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.

• Bulevirtide

  • Extension of the indication for the treatment of chronic hepatitis delta virus (HDV) infection in pediatric patients aged 3 years and older weighing at least 10 kg with compensated liver disease for Hepcludex.
• Clesrovimab

• Letermovir

  • Letermovir monotherapy for the prophylactic treatment of reactivation of cytomegalovirus infection in neonates, infants, toddlers, children and adolescents at risk of developing CMV infection following allogeneic hematopoietic stem cell transplantation.

• Nirsevimab

  • Extension of the indication for the prevention of respiratory syncytial virus (RSV) in the lower respiratory tract for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• Pritelivir