Gepubliceerd op 4 juni 2024

ADHD

• Guanfacine ^G

ALL

• ARI-0001

• Blinatumomab

  • Extension of indication to include treatment as part of consolidation therapy for the treatment of patients with 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).
• Crisantaspase
• Obecabtagene autoleucel

• Ponatinib

  • Extension of indication to include treatment of newly diagnosed adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), either with Iclusig (ponatinib) in combination with chemotherapy, or with Iclusig (ponatinib) monotherapy after corticosteroid induction in patients not eligible to receive chemotherapybased regimens.

ALS

• Ibudilast

• Masitinib

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

• Pridopidine

  • Amyotrophic lateral sclerosis (ALS)
• Reldesemtiv
• Tofersen

AML/MDS

• Decitabine / cedazuridine

  • Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy
• Imetelstat

• Ivosidenib

  • Tibsovo in combinatie met azacitidine is geïndiceerd voor de behandeling van volwassen patiënten met nieuw gediagnosticeerde acute myeloïde leukemie (AML) met een R132-mutatie in isocitraatdehydrogenase-1 (IDH1), die niet in aanmerking komen voor standaard inductiechemotherapie.

• 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

• Quizartinib

  • Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

Alvleesklierkanker

• Gemcitabine
• Irinotecan in gepegyleerde liposomen ^IND

Antitrombotische medicatie

• 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 (0.15 mg granules in capsules for opening, as well as 0.5, 1.5 and 2 mg coated granules in sachet).
• Dabigatran ^G
• Tenecteplase ^IND

Astma

• Depemokimab

• Tezepelumab

  • Add-on treatment in adult and adolescent patients with severe asthma

Baarmoederhalskanker

• Cadonilimab

• Dostarlimab

  • 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

• Olaparib

  • Extension of indication for Lynparza in combination with Imfinzi for the maintenance treatment of adult patients with newly diagnosed advanced or recurrent endometrial cancer following treatment with Imfinzi and platinum-based chemotherapy
• Tisotumab vedotin

Bacteriele infecties

• Aztreonam / avibactam
• Bezlotoxumab ^IND

• 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.
• Durlobactam / sulbactam
• Faecal microbiota transplant
• Gepotidacin
• Peginterferon alfa-2a ^IND
• Ridinilazole

• Vonoprazan

  • Patients With Helicobacter Pylori Infection

Blaaskanker

• Enfortumab vedotin

  • Enfortumab vedotin and pembrolizumab in untreated locally advanced or metastatic urothelial cancer.

• 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.
• Inbakicept

• 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

Borstkanker

• 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.

• 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
• Inavolisib ^IND

• 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

  • Histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist.

• 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
  • Extension of indication for Enhertu to include treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
  • 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 the existing CLL indication to include combination treatment with venetoclax for previously untreated patients.

• 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 of indication 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

  • Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), 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
  • Extension of indication to include treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
• Sabizabulin
• Vilobelimab

Chronische immuunziekten, overig

• 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
• 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.

• Budesonide

  • Kinpeygo is indicated for the treatment of adults with a urine protein excretion-to-creatinine ratio (UPCR) ≥1.0 g/dayg (or urine protein-to-creatinine ratio ≥0.8 g/g).
• Coacillium topical

• Dupilumab

  • Dupixent is geindiceerd 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, who are symptomatic despite treatment with H1 antihistamines and who are intolerant to or inadequately controlled by anti-IgE therapy for Dupixent.

• Iptacopan

  • C3 glomerulopathy (C3G)

• Leniolisib

  • Treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adolescents and adults 12 years or older.
• Lorecivivint
• Marnetegragene autotemcel

• Obinutuzumab

  • Lupus Nephritis

• Ritlecitinib

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

• Sarilumab

  • Volwassen patienten met polymyalgia rheumatica (PMR)
• Sebetralstat
• Teprotumumab

Darmkanker

• Fruquintinib

• Nivolumab

  • Extension of indication to include OPDIVO in combination with ipilimumab in the first-line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer
• Pembrolizumab / favezelimab

• Trifluridine / tipiracil

  • Lonsurf is geïndiceerd in combinatie met bevacizumab voor de behandeling van volwassen patiënten met gemetastaseerd colorectaal carcinoom (CRC) die eerder twee kankerbehandelschema’s hebben gekregen, waaronder chemotherapie op basis van fluorpyrimidine, oxaliplatine en irinotecan, antiVEGF-middelen en/of anti-EFGR-middelen.

Darmziekten

• 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
  • Crohn's disease
• 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.

• 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’).

Dementie

• Blarcamesine
• Donanemab
• Lecanemab
• NE3107

Depressie

• Agomelatine ^IND
• Zuranolone

Diabetes

• 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

  • Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes.
• Insulin Icodec
• Regulatoire T-cellen (TREGS)
• Teplizumab

Duchenne

• Fordadistrogene movaparvovec

• Givinostat

  • Ambulant Patients With Duchenne Muscular Dystrophy
• Losmapimod

• Vamorolone

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

Eierstokkanker

• 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).

• Rucaparib

  • Extension of indication as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Epilepsie

• Diazepam nasaal
• Ganaxolone

Fungale infecties

• Olorofim
• Rezafungin

HIV

• Dolutegravir/ abacavir /lamivudine ^IND
• Semzuvolimab

Hematologie, overig

• Lenzilumab

• Obinutuzumab

  • Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.

Hemostase bevorderende medicatie

• 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

• Vonicog alfa

  • Extension of indication for the prevention and treatment of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.

Hersenkanker

• Dabrafenib / trametinib

  • Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
• Paclitaxel trevatide
• Vorasidenib

Hodgkin lymfoom

• 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)

Hoofd- en halskanker

• Atezolizumab

  • Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

• Leukocyte interleukin

  • Cancer of the oral cavity, neoadjuvant

• Tislelizumab

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

Hoofdpijn

• Atogepant

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

Huidkanker

• Daromun

• Ipilimumab

  • Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma.
  • Neoadjuvant Ipilimumab Plus Nivolumab in Macroscopic Stage III Melanoma.

• 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
• Nivolumab/relatlimab/hyaluronidase Ph20
• Relatlimab / nivolumab
• Tucidinostat

Huidziekten

• Abrocitinib

  • Abrocitinib is geïndiceerd voor de behandeling van matige tot ernstige atopische dermatitis bij adolescenten vanaf 12 jaar tot en met 17 jaar welke in aanmerking komen voor systemische therapie.
• 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
• Delgocitinib

• Deucravacitinib

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

• 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 40 kg who are candidates for systemic therapy.
• Methotrexaat ^IND
• Nemolizumab
• Piclidenoson
• Prademagene zamikeracel
• Remibrutinib

• Roflumilast topicaal

  • Chronic plaque psoriasis

• Secukinumab

  • Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy

• Spesolimab

  • Spevigo is indicated for the prevention of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

Infectieziekten, overig

• Cefepime / Enmetazobactam
• Cefepime/taniborbactam

Leverkanker

• Atezolizumab

  • Extension of indication to include, in combination with bevacizumab, adjuvant treatment of adult patients with hepatocellular carcinoma at high risk of recurrence after surgical resection or ablation.

• 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.
• Namodenoson

• Tremelimumab

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

Leverziekten

• 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

  • Extension of indication to include treatment of cholestasis and pruritus in Alagille syndrome (ALGS) in patients from birth and older for BYLVAY.
• Resmetirom
• Seladelpar

Lipidenverlagende medicatie

• Alirocumab

  • Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies.

• Evinacumab

  • Extension of indication to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia (HoFH) aged 5 years and older
  • Extension of indication for EVKEEZA to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia aged 6 months to less than 5 years
• Lomitapide ^IND
• Pravastatine/​fenofibraat ^IND

Longkanker

• Adagrasib

• 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).
  • Amivantamab in combination with chemotherapy 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) after osimertinib failure.

• Atezolizumab

  • Subcutaneous formulation of atezolizumab for treatment of PD-(L)-1 Cancer Immunotherapy in multiple tumor types.
  • Extension of indication to include first-line treatment of adult patients with non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy and who do not have EGFR mutant or ALK-positive disease, who have: locally advanced unresectable NSCLC not amenable for definitive chemoradiotherapy, or metastatic NSCLC.
• 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

  • 1L advanced NSCLC
  • 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)

• Encorafenib

  • Extension of indication to include binimetinib in combination with encorafenib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

• Ipilimumab

  • Extension of indication to include in combination with nivolumab the treatment of adult patients with unresectable stage III NSCLC
• Lazertinib

• Lenvatinib

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

• 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.

• Nivolumab

  • Extension of indication to include OPDIVO for the treatment of patients with resectable stage II-IIIB non-small cell lung cancer
  • OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%
• Ociperlimab

• Osimertinib

  • Extension of indication to include treatment of adult patients with locally advanced, unresectable (stage III) 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.
  • Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
  • 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.
• Pembroliuzmab ^IND

• Pembrolizumab

  • Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence in adults
  • KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.

• 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

  • Treatment of extensive-stage small cell lung cancer (ES-SCLC)

• 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.

• 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
  • Extension of indication to include treatment of adult patients with non-small cell lung cancer (NSCLC) in combination and as monotherapy
  • 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
  • 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

• Toripalimab

  • Patients with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion in combiantion With Chemotherapy.

• 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.

Longziekten, overig

• Benralizumab

  • Extension of indication to include treatment of eosinophilic granulomatosis.
• Brensocatib
• Gefapixant

• Nintedanib

  • Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years.
• Pamrevlumab

• Sotatercept

  • Treatment of Pulmonary Arterial Hypertension
• Zinpentraxin alfa

Maagkanker

• Catumaxomab

• Domvanalimab

  • previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma

• Pembrolizumab

  • Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
  • Extension of indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• 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

Multipel Myeloom

• 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

  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT.

• 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

  • In Combination With Bortezomib, Lenalidomide and Dexamethasone (Isa VRd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant.
  • In combination with bortezomib, lenalidomide and dexamethasone (Isa VRd) in patients with newly diagnosed multiple myeloma (NDMM) eligible for transplant.

• Pomalidomide

  • Treatment of adult patients with relapsed and refractory multiple myeloma in combination with dexamethasone

• 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 sclerose

• 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

Myeloproliferatieve aandoeningen

• 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
• Pelabresib

• Pemigatinib

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

Neurologie, overig

• Clazosentan
• Deutetrabenazine (Extended release)
• Eplontersen

• Human normal immunoglobulin

  • Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg for adults, children and adolescents (0 to 18 years).
• Nepla-tem-cel

• Ravulizumab

  • voor de behandeling van volwassen patiënten met NMOSD die positief zijn voor antilichamen tegen aquaporine-4 (AQP4)

• Satralizumab

  • Patiënten met neuromyelitis optica‑spectrumstoornissen (NMOSD), die seropositief zijn voor anti-aquaporine-4-IgG (AQP4-IgG) (vanaf 12 jaar).

• Tiratricol

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

Nierkanker

• Belzutifan

  • Advanced renal cell carcinoma

• Cabozantinib

  • Cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced or metastatic renal cell carcinoma.

Non-hodgkin lymfoom agressief

• Acalabrutinib

  • Mantle cell lymphoma (MCL), 1L.

• 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.

• Brentuximab vedotin

  • Extension of indication for ADCETRIS to include treatment 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.
  • Extension of indication to include in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

• Epcoritamab

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

• Glofitamab

  • 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 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

• Pirtobrutinib

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.

• 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)

Non-hodgkin lymfoom indolent

• Epcoritamab

  • Extension of indication to include treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy

• Tafasitamab

  • MINJUVI is indicated in relapsed/ refractory follicular and marginal zone 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.

Onbekend

• ARINA-1

• Apremilast

  • Treatment of psoriatic arthritis, psoriasis, Behçet’s disease

• 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.

• 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 10 kg with compensated liver disease for Hepcludex.
• Colistimethate Sodium ^IND

• 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).
• Mirabegron ^IND
• Molgramostim ^IND
• Mycofenolaatmofetil ^IND

• Olezarsen

  • Familial chylomicronemia syndrome

• Pegcetacoplan

  • adolescents aged 12 years or older and adults who have C3 glomerulonefritis glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN).

• Pembrolizumab

  • Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive therapy.
• Pitavastatine
• Relugolix / estradiol / norethisterone acetaat ^IND
• Vibegron

Oncologie, overig

• AL102
• Afamitresgene autoleucel

• Catequentinib

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

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric 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.
• Futibatinib
• Melphalan hydrochloride
• NY-ESO-1 autologous engineered TCR-T cells
• Nirogacestat

• Nivolumab

  • Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO.

• Pembrolizumab

  • Indication for treatment in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
  • Extension of indication to include in combination with pemetrexed and platinum chemotherapy the first -line treatment of adults and adolescents aged 12 years and older with unresectable advanced or metastatic malignant pleural mesothelioma.
• Repotrectinib

• Retifanlimab

  • Patiënten met inoperabele, lokaal gevorderd of gemetastaseerd plaveiselcarcinoom van het anale kanaal.
  • Zynyz is indicated as monotherapy for the first‑line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy

• 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)
  • Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

• Toripalimab

  • Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”)
  • Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)

Oogaandoeningen

• Avacincaptad pegol
• Bevacizumab-vikg
• Bimatoprost
• 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)
• Laruparetigene zosaparvovec

• Pegcetacoplan

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

• Ranibizumab

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

Overige medicatie hart-en vaatziekten

• 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
• Ferric carboxymaltose

• Macitentan

  • Extension of indication to include, as monotherapy or in combination, the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 1 month to less than 18 years of age of WHO Functional Class (FC) I to III.
• Macitentan / tadalafil

• Mavacamten

  • Camzyos is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
• Neoatricon (dopamine)
• Omecamtiv mecarbil

• Sotagliflozine

  • Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure
• Zalunfiban

Overige niet-oncologische hematologische medicatie

• Apadamtase alfa
• Aprocitentan

• Concizumab

  • Hemofilie A met inhibitors en hemofilie B met inhibitors, met een leeftijd van 12 jaar en ouder.
  • Hemofilie A en B zonder inhibitors en een leeftijd van 12 jaar en ouder.
• Crovalimab
• Danicopan
• Efanesoctocog alfa ^IND
• Exagamglogene autotemcel
• Giroctocogene fitelparvovec

• Hydroxycarbamide

  • Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age

• Iptacopan

  • Treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

• Marstacimab

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

• Pegcetacoplan

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

Parasitaire infecties

• Lotilaner

Prostaatkanker

• Atezolizumab

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

• Degarelix

  • Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer, for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy and as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

• Enzalutamide

  • Extension of indication to include treatment as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy

• 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

  • Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

• 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.

Reuma

• 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

• Sarilumab

  • Patients aged 2-17 years with Polyarticular Juvenile Idiopathic Arthritis (pJIA)

SMA

• Apitegromab

• Risdiplam

  • Extension of indication to include treatment of patients below 2 months of age.

Schildklierkanker

• 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).

Schizofrenie, psychose, bipolaire stoornis

• Roluperidon
• Xanomeline/ trospium

Spierziekten, overig

• Baclofen / naltrexone / sorbitol
• Dantroleen ^G
• Daxibotulinumtoxine A
• Deoxythymidine / deoxycytidine
• Di-deuterated ethyl linoleate

• Eculizumab

  • Extension of indication to include treatment of paediatric patients aged 6 years and above with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.

• 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).
• Omaveloxolone
• Rozanolixizumab

• Satralizumab

  • Generalized Myasthenia
• Zilucoplan

Stamceltransplantaties

• Abatacept

  • Extension of indication to include the prophylaxis of acute Graft versus Host Disease (aGvHD) in the adult and paediatric population for Orencia.
• ECT-001-CB
• Nomacopan

• Treosulfan

  • Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients, and in paediatric patients older than one month with malignant and non‑malignant diseases.

Stofwisseling en Endocrinologie, overig

• 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
• C-type natriuretic peptide prodrug
• Copper histidine

• Linzagolix

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

• 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.

• 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.

• Vosoritide

  • Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Stofwisselingsziekten

• Afamelanotide

  • Extension of indication for the prevention of phototoxicity in adolescent patients (12 to under 18 years of age) with erythropoietic protoporphyria (EPP).
• 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
• N-Acetyl-L-Leucine
• Nedosiran

• Olezarsen

  • Severe Hypertriglyceridaemia
• Palopegteriparatide
• Paltusotine
• Pegunigalsidase alfa
• RGX-121
• 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)

• 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

Taaislijmziekte

• Ivacaftor / Tezacaftor / Elexacaftor ^IND

• Lumacaftor / ivacaftor

  • Extension of indication to include treatment of cystic fibrosis for children aged 1 to less than 2 years old of age who are homozygous for the F508del mutation in the CFTR gene.
• Vanzacaftor

Tumoragnostische geneesmiddelen

• 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.

Virale infecties, overig

• Bulevirtide

  • Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.
• 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.

• Nirsevimab

  • Extension of indication to include treatment of children up to 24 months of age who remain vulnerable to severe Respiratory Syncytial Virus (RSV) disease through their second RSV season.