Published on 7 December 2022 Oncology Abemaciclib IND Adagrasib Afamitresgene autoleucel Amivantamab Atezolizumab Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK‑positive NSCLC IND Atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation IND Avelumab First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer. IND Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. IND Balixafortide Cabozantinib Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. IND Cabozantinib monotherapy in adults and adolescent patients (aged 12 years and older) with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not candidates to radioactive iodine (RAI) who have progressed during or after prior systemic therapy IND Cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with only 1 anti-PD-L1/PD-1 checkpoint-inhibitor and platinum-containing chemotherapy, either sequentially or concurrently (without a targetable oncogenic driver) for 2L or 3L (line depending on previous treatment regime) IND Capmatinib Catumaxomab Cemiplimab Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. IND Extension of indication to include LIBTAYO in combination with platinum‐based chemotherapy for the first-line treatment of adult patients with locally advanced NSCLC who are not candidates for definitive chemoradiation or metastatic NSCLC with no EGFR, ALK or ROS1 aberrations, independen of PD-L1 expression. IND LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. IND Dabrafenib / trametinib Darleukin fibromun Darolutamide IND Degarelix G Dostarlimab Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen. Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer") IND Durvalumab Extension of indication to include first-line treatment, with Imfinzi in combination with tremelimumab and platinum-based chemotherapy, of adults with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. IND Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker. IND Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L. IND 1L advanced NSCLC IND Completely resected NSCLC IND Lokaal gevorderd, niet-resectabel NSCLC (stadium III) IND Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC. IND Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). IND Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). IND Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab. IND Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy IND Efbemalenograstim alfa Eflornithine / sulindac Elacestrant Enfortumab vedotin Ensartinib Enzalutamide IND Erdafitinib Adults and paediatric patients with unresectable locally advanced or metastatic solid tumours harbouring susceptible FGFR mutations or fusions, who have progressed on or after at least 1 line of systemic therapy and have no satisfactory alternative treatments (tumor-agnostisch) Patients with locally advanced and unresectable or metastatic urothelial carcinoma who have progressed on or after 1 or 2 prior treatments with prespecified (FGFR) gene aberrations (FGFR+ blaaskanker) Futibatinib Glucarpidase Gozetotide Ilixadencel Inbakicept Infigratinib Ipilimumab IND Ivosidenib Jodium (131I) omburtamab Lenvatinib Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation IND KISPLYX is indicated for the treatment of adults with advanced renal cell carcinoma (RCC) in combination with pembrolizumab, as first-line treatment. IND Advanced Hepatocellular Carcinoma (1L) in combination with pembrolizumab IND Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab. IND Advanced or Recurrent Non Small Cell Lung Cancer (1L, non squamous) in combination with pembrolizumab. IND Unresectable Advanced Melanoma (1L) in combination with pembrolizumab. IND Leuprolide mesylate Lifileucel Malignant melanoma, advanced melanoma. Treatment of Patients With Cervical Carcinoma (2L) Lipegfilgrastim IND Lurbinectedin Lutetium (177lu) vipivotide tetraxetan Masitinib Mirvetuximab soravtansine Mobocertinib NY-ESO-1 autologous engineered TCR-T cells Neratinib IND Niraparib / abiraterone Nirogacestat Nivolumab Extension of indication for Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC IND Extension of indication to include OPDIVO in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC). IND Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy). IND OSE-2101 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. IND Treatment in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. IND Paclitaxel Palbociclib IND Pembrolizumab KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence. IND Advanced Hepatocellular Carcinoma in combination with lenvatinib (1L). IND Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC). IND Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. IND Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. IND Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1. IND Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 10. IND Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation. IND 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib. IND KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection IND Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. IND Treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). IND Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with Stage IB (T2a ≥ 4 cm), II or IIIA non-small cell lung carcinoma (NSCLC) who have undergone complete resection. IND indication for treatment with pembrolizumab in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) in the treatment of HER2 negative advanced gastric or GEJ adenocarcinoma in adult participants. IND indication for treatment with pembrolizumab plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma IND 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 IND Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. IND Pralsetinib Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. Gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with Tyrosine Kinase inhibitors and not previously treated with a RET inhibitor. IND Gavreto is indicated for the treatment of adults and pediatric patients 12 years of age and older with locally advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with Tyrosine kinase inhibitors and not previously treated with a RET inhibitor. IND Relatlimab / nivolumab Relugolix Ripretinib Rucaparib IND Sacituzumab govitecan For adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease Eerder behandelde HR+/HER2- gemetastaseerde borstkanker IND Selinexor IND Selpercatinib 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC) IND Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC) IND Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. IND 2L+tumour agnostic–RET positive, no other satisfactory options IND Selumetinib Sintilimab Sodium thiosulfate Sotorasib Surufatinib Talazoparib IND Tavokinogene telseplasmid Tebentafusp Tepotinib Tesetaxel Tislelizumab 2L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma) 2L NSCLC (mono): As monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults 1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma) 1L locally advanced or metastatic gastric carcinoma IND 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations 1L recurrent/metastatic nasopharyngeal cancer (NPC). IND 1L squamous NSCLC (combi): In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults Tivozanib IND Toripalimab Trastuzumab deruxtecan 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. 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. IND 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. IND Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or withing 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer must additionally have received or be ineligible for endocrine therapy. IND Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC). IND Trastuzumab duocarmazine Tremelimumab Extension of indication in combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). IND Treatment of adults with metastatic NSCLC with no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Trilaciclib Tucatinib Zolbetuximab Hematology ARI-0001 Acalabrutinib Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Extension of the existing CLL indication to include combination treatment with venetoclax for previously untreated patients. IND Mantle cell lymphoma (MCL), 1L. IND Asciminib 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. IND Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. IND Belantamab mafodotin IND Bomedemstat Brexucabtagene autoleucel Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. 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). IND Carfilzomib IND Ciltacabtagene autoleucel Crisantaspase Crizotinib IND Cytarabine / daunorubicin (liposomaal) IND Daratumumab Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT. IND Smouldering multipel myeloom. IND Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT. IND Decitabine / cedazuridine Elranatamab Epcoritamab Eprenetapopt Glasdegib Glofitamab Hypericin Ibrutinib Mantle cell lymphoma (MCL), 1L. IND Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) IND Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation IND Idecabtagene vicleucel Imetelstat Isatuximab Sarclisa is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. IND In Combination With Bortezomib, Lenalidomide and Dexamethasone (Isa VRd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant. IND Ivosidenib Ixazomib IND Lacutamab Lenzilumab Lisocabtagene maraleucel Treatment of large B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after at least two previous lines of treatments. Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi. IND Loncastuximab tesirine Melphalan flufenamide IND Momelotinib Mosunetuzumab Narsoplimab Navitoclax Obecabtagene autoleucel Omidubicel Parsaclisib Pirtobrutinib Plerixafor G Polatuzumab vedotin IND Pomalidomide IND Ponatinib IND Quizartinib Ruxolitinib IND Selinexor IND Tabelecleucel Tafasitamab Teclistamab Thalidomide G Tisagenlecleucel-T IND Treosulfan IND UM171 Ublituximab Venetoclax IND Zamtocabtagene autoleucel Zanubrutinib Mantle-cell lymphoma (1L) + Rituximab. IND Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL). IND 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 IND Zevorcabtagene autoleucel Metabolism and Endocrinology ALXN1840 Abaloparatide Treatment of osteoporosis in postmenopausal women at increased risk of fracture Treatment of osteoporosis. Alpelisib Arachidyl amido cholanoic acid Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene Avalglucosidase alfa Bardoxolone Methyl Bexagliflozine Burosumab IND Cipaglucosidase alfa / miglustat Corifollitropin alfa IND Diazoxide choline (controlled-release tablet) Dulaglutide IND Empagliflozine IND Exenatide IND Fexapotide Fezolinetant Finerenon Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. Extension of indication to include the treatment of chronic kidney disease (CKD) and for the prevention of cardiovascular (CV) events in adults with CKD (regardless of the stage of albuminuria) associated with type 2 diabetes IND Fosdenopterin Ganirelix G Insulin lispro IND Insuline Icodec Leriglitazone Levonorgestrel G Linzagolix Yselty is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Moderate to Severe Endometriosis Associated Pain IND Liraglutide IND Lixivaptan Lonafarnib Lonapegsomatropin Lumasiran Maralixibat Mirabegron IND Octreotide Olenasufligene relduparvovec Olipudase alfa Ospemifene IND Palovarotene Pariglasgene brecaparvovec Pegunigalsidase alfa Pegzilarginase Polyethylene glycol loxenatide RGX-121 Regulatoire T-cellen (TREGS) Reloxaliase Relugolix IND Relugolix / estradiol / norethisteronen Seladelpar Semaglutide For weight management in people with obesity or who are overweight and have other related conditions. Extension of indication to include treatment of adolescents for weight management for Wegovy. IND Setmelanotide Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above. IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet‑Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above. IND Sofpironium bromide Somapacitan Somatrogon Sotagliflozine IND Sparsentan Teplizumab Tirzepatide TransCon PTH (palopegteriparatide) Vibegron Vosoritide Chronic immune diseases Anifrolumab 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. IND Non-advanced systemic mastocytosis IND Baricitinib Systemic lupus erythematosus IND Extension of indication to include treatment of severe alopecia areata in adult patients for Olumiant. IND Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs. IND Pediatric atopic dermatitis IND Beremagene geperpavec Berkenschorsextract Berotralstat Bimekizumab Extension of indication to include Bimzelx, alone or in combination with conventional disease-modifying antirheumatic drugs (cDMARDs), 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 DMARDs. IND Extension of indication to include treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS, radiographic axial spondyloarthritis) IND Budesonide modified released capsule Canakinumab IND Coacillium topical Concentrate of proteolytic enzymes enriched in bromelain IND Cyclobenzaprine hydrochloride Dabocemagene autoficel Deucravacitinib Difelikefalin Dupilumab Dupixent is geïndiceerd bij kinderen van 6 maanden tot 6 jaar met ernstige atopische dermatitis die in aanmerking komen voor systemische behandeling. IND Dupixent is geïndiceerd bij volwassenen en adolescenten van 12 jaar en ouder voor de behandeling van eosinofiele oesofagitis die onvoldoende onder controle zijn door, of die intolerant zijn voor, of die geen kandidaat zijn voor conventionele medicamenteuze therapie. IND Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. IND Etrasimod Etrolizumab IND FCR 001 Filgotinib IND Lebrikizumab Leniolisib Marnetegragene autotemcel Mavorixafor Mirikizumab Olopatadine / mometasone Regenerative Skin Tissue Risankizumab Skyrizi 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. IND Indicated for UC (collitis ulcerosa) with demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies. IND Ritlecitinib Roflumilast topicaal Ruxolitinib phosphate Sarilumab IND Secukinumab Extension of indication to include treatment of Hidradenitis Suppurativa (HS) for Cosentyx. IND Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. IND Sirolimus G Sizavaleucel Spesolimab Sutimlimab Teduglutide IND Tocilizumab BS Tralokinumab IND Upadacitinib Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. IND Extension of indication to include treatment of moderately to severely active Crohn's disease in adult patients. IND RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). IND Vedolizumab IND Voclosporin Vonoprazan Infectious diseases APN01 Anakinra IND Baloxavir marboxil IND Baricitinib IND Bizalimogene ralaplasmid Bulevirtide Casirivimab / imdevimab Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg . Extension of indication to include treatment of COVID-19 in hospitalised patients in adults and adolescents aged 12 years and older weighing at least 40 kg for Ronapreve IND Cefepime / Enmetazobactam Ceftobiprole Ceftolozane / tazobactam IND Citric acid / lactic acid / potassium bitartrate IND Clindamycin Dalbavancine IND Doravirine / lamivudine / tenofovirdisoproxil IND Durlobactam / sulbactam Eravacycline Fluticasone propionate Ibrexafungerp Lenacapavir Letermovir Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant IND Letermovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients IND Lonafarnib IND Lotilaner Maribavir Molnupiravir Nirsevimab Oritavancin diphosphate IND Oteseconazole PF-07321332 / ritonavir Posoleucel Raltegravir BS Remdesivir Treatment of paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) or other non-invasive ventilation at start of treatment IND Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 IND Rezafungin SER 109 Tebipenem Tenofovir alafenamide IND Tixagevimab / cilgavimab Pre-expositie profylaxe van COVID-19 bij volwassenen en adolescenten van 12 jaar en ouder met een lichaamsgewicht van tenminste 40 kilo Evusheld is indicated for the treatment of adults and adolescents (aged 12 years and older weighing at least 40kg) with COVID‑19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19. IND UB 421 Lung diseases Benralizumab IND Dupilumab IND Ensifentrine Gefapixant Lumacaftor / ivacaftor IND Masitinib Nintedanib IND Pamrevlumab Pirfenidone Pirfenidone Axunio is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). G Extension of indication to include the treatment of advanced Idiopathic Pulmonary Fibrosis (IPF) for Esbriet. IND Riociguat IND Tezepelumab tocilizumab IND Neurological disorders Aflibercept Diabetic macular edema BS Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease. IND Agomelatine IND Arimoclomol Atogepant Avacincaptad pegol Bidridistrogene xeboparvovec Bupivacaine Buprenorfine IND Bupropion / dextromethorphan Cannabidiol Epidyolex is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older. IND Children and Adolescents With Fragile X Syndrome aged 3 to < 18 years. Clazosentan Dantroleen G Daridorexant Daxibotulinumtoxine A Deoxythymidine / deoxycytidine Dexmedetomidine Di-deuterated ethyl linoleate Dihydroergotamine Dimethyl fumarate IND Donanemab Efgartigimod Eladocagene exuparvovec Eptinezumab Esketamine IND Faricimab Treatment of neovascular (wet) age-related macular degeneration (nAMD). Treatment of visual impairment due to diabetic macular oedema (DME). Fasinumab Fenfluramine IND Fordadistrogene movaparvovec Ganaxolone Gantenerumab Givinostat Golodirsen Inebilizumab JZP-258 Lacosamide IND Lasmiditan Lenadogene nolparvovec Levodopa / carbidopa Lisdexamfetamine IND Masitinib Melatonine Meloxicam / rizatriptan Molindone Natalizumab BS Natriumoxybaat controlled release Omaveloxolone Pegcetacoplan Perfluorohexyloctane Phentolamine Pitolisant Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP). Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years. IND Polihexanide Ranibizumab Wet age-related macular degeneration (AMD). BS Treatment of neovascular age-related macular degeneration (AMD) Wet age-related macular degeneration (AMD) BS Ravulizumab Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive. IND Extension of indication to include the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive. IND Reproxalap Rimegepant Acute treatment of migraine with or without aura in adults Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month Risdiplam 5q SMA in patients 2 months of age and older, with a clinical diagnosis of Type 1, Type 2 or Type 3 SMA or with one to four SMN2 copies. Extension of indication to include treatment of patients below 2 months of age. IND Roluperidon Rozanolixizumab SDN037 Satralizumab Patiënten met neuromyelitis optica‑spectrumstoornissen (NMOSD), die seropositief zijn voor anti-aquaporine-4-IgG (AQP4-IgG) (vanaf 12 jaar). Generalized Myasthenia IND Sepofarsen Sodium phenylbutyrate / tauroursodeoxycholic acid Teriflunomide Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G Tiratricol Tominersen Trofinetide Ublituximab Vamorolone Viltolarsen Vutrisiran Zilucoplan Cardiovascular diseases Angiotensin II Bempedoic acid Crizanlizumab Dabigatran G Danicopan Dapagliflozine IND Daprodustat Eculizumab BS Efgartigimod Eltrombopag IND Emicizumab IND Eptacog alfa IND Eptacog alfa (activated) BS Eptacog beta (activated) Etranacogene dezaparvovec Etripamil Evinacumab Exagamglogene autotemcel Ferumoxytol Fidanacogene elaparvovec Horse anti-human T lymphocyte immunoglobulin Icosapent ethyl Iptacopan Luspatercept IND Macitentan IND Macitentan / tadalafil Mavacamten Methoxy polyethylene glycol-epoetin beta IND Mitapivat Mozafancogene autotemcel Neoatricon (dopamine) Omecamtiv mecarbil Pegcetacoplan Proteïne C IND Ravulizumab Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Uitbreiding van de behandeling naar pediatrische patiënten met een lichaamsgewicht van 10kg of meer met paroxismale nachtelijke hemoglobinurie (PNH):- bij patiënten met hemolyse met klinische symptomen die wijzen op een hoge ziekteactiviteit.- bij patiënten die klinisch stabiel zijn nadat ze ten minste de afgelopen 6 maanden behandeld zijn met eculizumab. IND Rexlemestrocel-L Rilonacept Sotagliflozine IND Sotatercept Tadalafil IND Treprostinil G UM171 Vadadustat Valoctocogene roxaparvovec Valsartan / sacubutril IND Voxelotor Older publications Published on 7 June 2022 Published on 7 December 2021 Published on 8 June 2021 Published on 8 December 2020 Published on 10 June 2020 Published on 10 December 2019 Published on 12 June 2019 Published on 13 December 2018 Published on 12 June 2018 Published on 9 January 2018