Published on 3 December 2024

ADHD

• Guanfacine ^G

ALL

• Blinatumomab

  • Indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD-19 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

ALS

• Lenzumestrocel

• Masitinib

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

• Pridopidine

  • Amyotrophic lateral sclerosis (ALS)
• Tofersen

AML / MDS

• Decitabine / cedazuridine

  • Extension of indication to include treatment of adult patients with myelodysplastic syndromes (MDS) and treatment of adult patients with chronic myelomonocytic leukaemia (CMML).
• Imetelstat
• Iodine (131I) apamistamab

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS)
• Magrolimab
• Olutasidenib
• Revumenib
• Tamibarotene

Aggressive non-Hodgkin’s lymphoma

• Acalabrutinib

  • Acalabrutinib monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly
  • Mantle cell lymphoma (MCL), 1L. Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated MCL

• 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

  • Glofitamab in combinatie met gemcitabine en oxaliplatine voor de behandeling van volwassen patiënten met recidiverende of refractaire diffuus groot B-cellymfoom (DLBCL), na één of meerdere lijnen systemische therapie.
  • 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.

• Ibrutinib

  • Imbruvica in combination with R-CHOP or R-DHAP for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplantation (ASCT).

• Lisocabtagene maraleucel

  • Breyanzi voor de behandeling van recidief of refractair grootcellig B-cellymfoom (R/R DLBCL), primair mediastinaal B-cellymfoom (PMBCL), en folliculair lymfoom graad 3B (FL3B), na twee of meer lijnen systemische therapie
  • 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.
• Odronextamab

• 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)
• Dabigatran ^G
• Edaravone / dexborneol
• Tenecteplase ^IND

Asthma

• Depemokimab

Bacterial infections

• Aztreonam / avibactam

• Ceftazidime / avibactam

  • Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) and in the treatment of infections due to aerobic Gram-negative organisms in patients with limited treatment options.

• Dalbavancine

  • Extension of indication to include the treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients from birth, including paediatric patients aged less than 3 months with suspected or confirmed sepsis associated with skin and subcutaneous tissue infections
• Faecal microbiota transplant
• Gepotidacin

• Minocycline

  • Minocycline in combination with standard of care antibiotics for adjunctive treatment of catheter related infection, central line sepsis in adolescents, adults and elderly
• Ridinilazole
• Sulopenem

• Tedizolid

  • Extension of indication to include treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients aged from birth to less than 12 years

• Vonoprazan

  • Patients With Helicobacter Pylori Infection
• Zoliflodacin

Bladder cancer

• Durvalumab

  • Extension of indication to include IMFINZI in combination with cisplatin-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for the treatment of adults with 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-resecteerbaar 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

• 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.
  • OPDIVO in combination with cisplatin-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

• 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 geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstige colitis ulcerosa die onvoldoende hebben gereageerd op, niet meer reageren op of intolerant waren voor conventionele behandeling of een biologische behandeling.
  • Tremfya is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstig actieve ziekte van Crohn die onvoldoende hebben gereageerd op, niet meer reageren op of intolerant waren voor conventionele behandeling of een biologische behandeling.

• Mirikizumab

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

• Upadacitinib

  • RINVOQ is geïndiceerd voor de behandeling van volwassen patiënten met matige tot ernstige actieve ziekte van Crohn die onvoldoende reageerden op, niet meer reageerden op of intolerant waren voor een conventionele behandeling of een biologisch geneesmiddel (‘biological’).

• Ustekinumab

  • Extension of indication to include treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy or have medical contraindications to such therapies for STELARA

Brain cancer

• Berubicin
• Dordaviprone
• Paclitaxel trevatide
• 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

• Atezolizumab

  • Atezolizumab plus chemotherapy for patients with early relapsing recurrent triple-negative breast cancer

• 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 inoperable or metastatic HR-Positive, HER2-negative Breast Cancer who have been treated with one or two prior lines of systemic chemotherapy.
• Elacestrant

• Gedatolisib

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

• 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

  • Extension of indication to include treatment of HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
  • 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
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens.

CLL

• Acalabrutinib

  • Extension of indication to include CALQUENCE in combination with venetoclax with or without obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

• Pirtobrutinib

  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukemia (CLL) who have been previously treated with a Bruton’s tyrosine kinase (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

• Bosutinib

  • Extension application to include treatment of paediatric patients greater than or equal to 1 year of age with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML)

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

COVID-19

• Casirivimab / imdevimab

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

• Remdesivir

  • Extension of indication to include treatment of COVID-19 for paediatric patients weighing at least 1.5 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

• 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: - as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

• 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.

• 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

• Fruquintinib

• Nivolumab

  • Extension of indication to include opdivo in combination with ipilimumab for the treatment of adults patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer and treatment of metastatic colorectal cancer after prior fluoropyrimidine‑based combination chemotherapy.
• 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
• Lecanemab

Depression

• Agomelatine ^IND
• 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.
• Deudomperidone
• Empagliflozine / metformine ^IND
• Insulin icodec
• Insulin icodec / semaglutide
• Regulatoire T-cellen (TREGS)
• Teplizumab

Duchenne

• Ataluren ^G
• Delandistrogene moxeparvovec
• Fordadistrogene movaparvovec

• Givinostat

  • Ambulant Patients With Duchenne Muscular Dystrophy

• Vamorolone

  • Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older
• Viltolarsen

Epilepsy

• Diazepam nasaal
• Midazolam ^IND

Eye disorders

• Acoltremon
• Avacincaptad pegol
• Bevacizumab-vikg
• Bimatoprost
• Botaretigene sparoparvovec
• Brimonidine tartrate/carbachol

• Ciclosporine

  • Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.

• 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

  • Extension of indication to include treatment of children from 6 months of age with paediatric cystinosis
• OCU400

• Pegcetacoplan

  • Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
• Polihexanide

• Ranibizumab

  • Treatment of neovascular age-related macular degeneration (AMD)
• Tarcocimab tedromer
• Timrepigene emparvovec
• Varenicline
• Veligrotug

Fungal infections

• Isavuconazole

  • Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is inappropriate
• Olorofim
• Rezafungin

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

  • Darunavir/cobicistat monotherapy for treatment of HIV-1 infection in children over 6 years of age weighing at least 25 kg.
• Dolutegravir/ abacavir /lamivudine ^IND

• Lenacapavir

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

• Rilpivirine

  • Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml
  • Extension of indication to include in combination with cabotegravir injection, the treatment of adolescents (at least 12 years of age and weighing at least 35 kg) for Rekambys
• Semzuvolimab

Head and neck cancer

• Buparlisib
• Cetuximab sarotalocan

• Leukocyte interleukin

  • Cancer of the oral cavity, neoadjuvant

• Tislelizumab

  • 1L recurrent/metastatic nasopharyngeal cancer (NPC).
• Xevinapant

Headache

• Atogepant

  • Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Hemostasis promoting medication

• Damoctocog alfa pegol

  • Extension of indication to include treatment and prophylaxis of bleeding in previously treated patients ≥7 years of age with haemophilia A

• Emicizumab

  • Hemlibra is indicated for Routine prophylaxis of bleeding episodes in patients with haemophilia A without factor VIII inhibitors who have moderate disease with severe bleeding phenotype.
• 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

Hodgkin's lymphoma

• Brentuximab vedotin

  • ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with large mediastinal mass and/or extranodal lesions or Stage III or IV Hodgkin lymphoma (HL) in combination with Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine (BrECADD)

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.

• Lisocabtagene maraleucel

  • Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory follicular lymphoma in adults and elderly who have received 2 or more prior 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

  • MINJUVI is indicated in relapsed/ refractory follicular lymphoma in combination with rituximab and lenalidomide.

• 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 / enmetazobactam
• Cefepime/taniborbactam

Kidney cancer

• Belzutifan

  • Advanced renal cell carcinoma

• 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

• 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

• 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
• Pravastatine / ​fenofibraat ^IND

Liver cancer

• Atezolizumab

  • Tecentriq in combination with bevacizumab for the treatment of adults with hepatocellular carcinoma (a cancer that starts in the liver), when the cancer has been removed by surgery or other techniques and is at high risk of coming back
• Camrelizumab

• Durvalumab

  • 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.

• Lenvatinib

  • Advanced Hepatocellular Carcinoma (1L) in combination with pembrolizumab
• 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

  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Liver diseases

• Arachidyl amido cholanoic acid
• Elafibranor

• Maralixibat

  • Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
  • Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

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

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

  • Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
  • 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)
• 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.
  • Extension of indication to include IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for the treatment of adults with resectable (tumours ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements.
  • Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
  • Completely resected NSCLC

• 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.
• 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)
• 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
• Patritumab deruxtecan ^IND

• Pembrolizumab

  • Pembrolizumab (MK-3475) Subcutaneous (SC) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
• Pembrolizumab / vibostolimab
• Pembrolizumab/hyaluronidase ^IND

• 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

• 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.
• 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.
  • Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab
  • Extension of indication to include first-line treatment of adult patients with extensive-stage Small Cell Lung Cancer (SCLC) for Tevimbra in combination with etoposide and platinum chemotherapy
  • Tizveni in combination with pemetrexed and platinum‑containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC

• 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.

• 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.

Lung diseases other

• Benralizumab

  • Extension of indication to include treatment of eosinophilic granulomatosis.
  • Patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids.
• Brensocatib
• Efzofitimod ^BS
• Gefapixant

• Nintedanib

  • Nintedanib Accord is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs; systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs; other chronic fibrosing interstitial lung diseases which are progressive.
  • Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years.
• Pamrevlumab

• Sotatercept

  • Treatment of Pulmonary Arterial Hypertension

• Tezepelumab

  • chronische rinosinusitis met neuspoliepen (CRSwNP)
• Zinpentraxin alfa

Metabolic diseases

• Avalglucosidase alfa
• Cipaglucosidase alfa

• Dasiglucagon

  • Infants and children aged 7 days to 12 years with congenital hyperinsulinism (CHI).
• Eliglustat ^IND
• Elinzanetant
• Encaleret
• Fezolinetant

• Govorestat

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

• Liraglutide

  • Extension of indication to include the use of SAXENDA for weight management in children from the age of 6 years to less than 12 years
• N-Acetyl-L-Leucine
• Nedosiran

• Olezarsen

  • Olezarsen monotherapy for add-on treatment of severe hypertriglyceridemia in adults and elderly
• Paltusotine
• Pegunigalsidase alfa
• Plozasiran
• RGX-121
• Rebisufligene etisparvovec

• Relacorilant

  • Cushing's Syndrome
• Sepiapterin

• Somapacitan

  • Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD)

• Somatrogon

  • Somatrogon monotherapy for treatment of growth hormone deficiency in adults

• Sparsentan

  • Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).
• Tiomolibdate choline

Multiple Myeloma

• Belantamab mafodotin

  • Multiple Myeloma 3L
  • 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)
  • In combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant

• Elranatamab

  • Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• 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.

• Selinexor

  • In combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die ten minste 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.

• Teclistamab

  • Tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• Venetoclax

  • Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

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
• Dantroleen ^G
• Doxecitine / doxiribtimine

• Efgartigimod

  • Vyvgart is geïndiceerd als een aanvulling op de standaardtherapie voor de behandeling van volwassen patiënten met gegeneraliseerde myasthenia gravis (gMG) die positief testen op antilichamen tegen acetylcholinereceptoren (AChR).

• Inebilizumab

  • Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or anti-MuSK antibody
• Losmapimod
• Nipocalimab
• Omaveloxolone
• Rozanolixizumab

• Satralizumab

  • Generalized Myasthenia

• Sugammadex

  • Extension of indication to include treatment of paediatric patients from birth to less than 2 years of age for Bridion based on final results from paediatric study PN169 (MK-8616-P169); this is a Phase 4 double-blinded, randomized, active comparator-controlled clinical trial to study the efficacy, safety, and pharmacokinetics of sugammadex (MK-8616) for reversal of neuromuscular blockade in paediatric participants aged birth to <2 years
• 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.
• Momelotinib
• Navitoclax
• 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

  • Als behandeling van volwassen patiënten met gemetastaseerd NET (neuro endocriene tumoren) na falen op ten minste één eerdere systemische therapie (everolimus en/of PRRT en/of sunitinib; afhankelijk van de exacte NET indicatie)
• Lutetium (177Lu) edotreotide

• Lutetium (177Lu) oxodotreotide

  • Lutetium (177lu) oxodotreotide in combination with long-acting octreotide for first line treatment of metastasized or locally advanced, inoperable, well differentiated Grade 2 or Grade 3 somatostatin receptor-expressing gastroenteropancreatic neuroendocrine tumour disease in adolescents over 15 years of age, adults and elderly
• Mirdametinib

Neurological disorders other

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

• Pridopidine

  • Early stage Huntington Disease

• Tiratricol

  • Treatment of children and adults with MCT8 deficiency (also called the Allan-Herndon-Dudley syndrome (AHDS))
• Trofinetide
• Troriluzole

• Vutrisiran

  • treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
  • Extension of indication to include treatment of wild-type or hereditary transthyretin-mediated amyloidosis in adult patients with cardiomyopathy (ATTR-CM)

Oncology other

• Afamitresgene autoleucel

• Belzutifan

  • The treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable or undesirable.
• Bezuclastinib

• Catequentinib

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

• Dostarlimab

  • MMRp EC
  • 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

  • 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.

• Ivosidenib

  • Monotherapie met Tibsovo is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderd of gemetastaseerd cholangiocarcinoom met een R132-mutatie in IDH1 die eerder zijn behandeld met minstens één eerdere lijn van systemische therapie.
• Letetresgene autoleucel
• Melphalan hydrochloride
• Nirogacestat
• 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
  • Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
• Pimicotinib
• Repotrectinib

• Retifanlimab

  • Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal.
  • ZYNYZ is geïndiceerd als monotherapie voor de eerstelijnsbehandeling bij volwassen patiënten met gemetastaseerd of recidiverend lokaal gevorderd merkelcelcarcinoom (MCC) dat niet vatbaar is voor curatieve chirurgie of bestraling.

• Selinexor

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

• Sugemalimab

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

• Tebentafusp

  • Kimmtrak is geïndiceerd als monotherapie voor de behandeling van humaan leukocytenantigeen (HLA)-A*02:01-positieve volwassen patiënten met een niet-resectabel of gemetastaseerd uveamelanoom.

• 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)

• 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.
• Varegacestat
• Vimseltinib

• Zanidatamab

  • Second line treatment of locally advanced unresectable HER2-positive biliary cancer metastatic in adults and elderly, monotherapy

Other chronic immune diseases

• Allergeenextract huisstofmijt ^IND
• Arachis hypogaea (pinda) allergenen ^IND
• Atrasentan

• Avapritinib

  • Extension of indication to include treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment.

• Belimumab

  • Extension of indication to include treatment of paediatric patients from 5 years of age with active, autoantibody-positive systemic lupus erythematosus (SLE) for BENLYSTA, based on final results from study 200908; this is a worldwide population pharmacokinetic analysis of subcutaneous administered belimumab plus standard therapy to pediatric patients aged 5-17 years with systematic lupus erythematous (SLE), which was aimed to describe the pharmacokinetic (PK) analysis of belimumab to support an appropriate weight-based dosing regimen for subcutaneous administration in paediatric patients aged 5-17 years with SLE

• Benralizumab

  • Bulleus pemfigoïd

• 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).
• 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.
  • Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, who are symptomatic despite treatment with H1 antihistamines and who are intolerant to or inadequately controlled by anti-IgE therapy.
• Epinephrine

• Iptacopan

  • Extension of indication to include, in combination with a renin-angiotensin system (RAS) inhibitor, the treatment of adult patients with complement 3 glomerulopathy (C3G)

• Leniolisib

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

• 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
• Teprotumumab

Other hematology

• Lenzilumab

Other medication for cardiovascular diseases

• Acoramidis
• Aficamten

• 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.
• Etripamil

• Finerenon

  • Treatment of patients with symptomatic chronic heart failure and ejection fraction ≥40%

• Macitentan

  • Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥ 40 kg with WHO Functional Class (FC) II to III.
• Macitentan / tadalafil
• Neoatricon (dopamine)

• Rilonacept

  • Treatment of idiopathic pericarditis
• 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
• Copper histidine

• Linzagolix

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

• Pegzilarginase

  • Loargys is indicated for the treatment of arginase 1 deficiency (ARG1‑D), also known as hyperargininemia, in adults, adolescents and children aged 2 years and older.
• Relugolix / estradiol / norethisterone acetaat ^IND

• Semaglutide

  • Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
  • For weight management in people with obesity or who are overweight and have other related conditions.
  • 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 indicatie uitbreiding 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.
• Setrusumab

• Tirzepatide

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

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

• 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

  • Mitapivat monotherapy for treatment of alpha or beta thalassaemia in adults and elderly
• 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
• Vadadustat

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).

Pancreatic cancer

• Gemcitabine ^IND
• Glufosfamide

Prostate cancer

• 177Lu-PNT2002

• Apalutamide

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

• 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.

• Niraparib

  • Niraparib in combination with abiraterone acetate and prednisone for treatment of patients with metastatic prostate cancer
• Niraparib-abirateron fixed dose combinatie ^IND

• Olaparib

  • Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.
• Radium-223 ^IND

• Relugolix

  • Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

• 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

• 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

• Filgotinib

  • Axial spondyloarthritis
• Golimumab ^BS

• Inebilizumab

  • Inebilizumab monotherapy for preventive treatment of immunoglobulin G4 related disease in adults and elderly at high risk of flare

• Ixekizumab

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

• 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.

• Upadacitinib

  • Extension of indication to include treatment of giant cell arteritis (GCA) in adult patients

SMA

• Apitegromab

Schizophrenia, psychosis, bipolar disorder

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

Skin cancer

• Daromun
• 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 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
• Tucidinostat

Skin diseases

• 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
• Concentrate of proteolytic enzymes enriched in bromelain ^IND
• Dabocemagene autoficel
• Delgocitinib

• Deucravacitinib

  • Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

• Guselkumab

  • Tremfya is geïndiceerd voor matige tot ernstige plaque psoriasis bij pediatrische patiënten (jonger dan18 jaar) die in aanmerking komen voor systemische therapie.

• Lebrikizumab

  • 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

• Roflumilast topicaal

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

• Ruxolitinib (als fosfaat)

  • Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
  • Opzelura is geïndiceerd voor de behandeling van volwassenen met matige atopische dermatitis die eerder zijn behandeld met topische corticosteroïden of topische calcineurineremmers of waarbij deze middelen zijn gecontra-indiceerd.

• Spesolimab

  • Spevigo is indicated for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age.

Sleep disorders

• Melatonine

  • Extension of indication for the treatment of insomnia in children and adolescents aged 2 till 18 to include neurogenetic disorders (e.g., Angelman syndrome, Rett syndrome, Tuberous sclerosis complex and Williams syndrome)

• 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

• Ripretinib

• Tislelizumab

  • 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

  • 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

Thyroid cancer

• Selpercatinib

  • Extension of indication to include the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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.

Unknown

• ARINA-1

• Apremilast

  • Treatment of psoriatic arthritis, psoriasis, Behçet’s disease
• Atacicept
• Colistimethate Sodium ^IND
• Exoflo Extracellular Vesicles
• Mirabegron ^IND

• Olezarsen

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

Viral infections other

• Baloxavir marboxil

  • Extension of indication to include treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 3 weeks and above

• Bulevirtide

  • Extension of indication to include treatment of chronic hepatitis delta virus (HDV) infection in paediatric patients 3 years of age and older weighing at least 10kg with compensated liver disease for Hepcludex.
• Clesrovimab ^IND

• Letermovir

  • Extension of indication to include treatment of prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].
  • Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant.
  • Letermovir monotherapy for prophylactic treatment of cytomegalovirus infection reactivation in newborns, infants and toddlers, children and adolescents who are at risk of developing CMV infection following an allogeneic haematopoietic stem cell transplantation

• Nirsevimab

  • Extention of indication for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• Posoleucel