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Published on
7 December 2022
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Mechanism of action
Any mechanism of action
Unknown
Alkylating agent
Allergen
Allogeneic modified cell therapy
Amino acid
Anesthetic
Angiogenesis inhibitor
Antiandrogen
Antibiotic
Antibody-drug conjugate
Anticoagulant
Antifungals
Antihistamine
Antioxidant
Antisense oligonucleotide
Autologous modified cell therapy
Bcl-2 inhibitor
BET inhibitor
Calcineurin inhibitor
Cancer vaccine
Cannabinoid
CAR-T therapy
CDK4 / 6 tyrosine kinase inhibitor
CFS1R inhibitor
CGRP-directed antibody
Chelating agent
Coagulant
Combination therapy
Complement inhibitor
Corticosteroid
CTLA-4 antibody
Cytostatic
Disinfectant
Enzyme
Enzyme inhibitor
Enzyme replacement therapy
Gene therapy
GLP-1 receptor agonist
Glucagon analogue
Growth factor
HIV inhibitor
Hormonal therapy
Immunostimulation
Immunosuppression
Insulin preparation
Interferon inhibitor
Interleukin inhibitor
Ion channel blocker
JAK tyrosine kinase inhibitor
LABA / ICS
LABA / LAMA
LABA / LAMA / ICS
LAMA
MEK kinase inhibitor
Neurotoxin
Neurotransmitter
Oncolytic adenovirus
Other
Other, see general comments
PARP inhibitor
PD-1 / PD-L1 inhibitor
Proteasome inhibitor
Protein chaperone
Receptor agonist
Receptor antagonist
Serine / threonine kinase inhibitor
SGLT inhibitor
Small interfering RNA (siRNA)
Sodium channel blocker
Thrombin inhibitor
TNF-alpha inhibitor
Tyrosine kinase inhibitor
Vasodilator
Virus inhibitor
Budgetting framework
Any budgetting framework
Unknown
Extramural (GVS)
Intermural (MSZ)
Particularity
Any particularity
Unknown
New medicine with Priority Medicines (PRIME)
New therapeutical formulation
Reason of inclusion
New medicines
Indication extensions
IND
Biosimilars / generics
BS
G
Download
ADHD
Lisdexamfetamine
IND
Melatonine
Molindone
ALL
ARI-0001
Brexucabtagene autoleucel
IND
Crisantaspase
Obecabtagene autoleucel
Ponatinib
IND
ALS
Arimoclomol
Masitinib
Sodium phenylbutyrate / tauroursodeoxycholic acid
AML / MDS
Cytarabine / daunorubicin (liposomaal)
IND
Decitabine / cedazuridine
Eprenetapopt
Glasdegib
Imetelstat
Ivosidenib
Quizartinib
Aggressive non-Hodgkin’s lymphoma
Acalabrutinib
IND
Axicabtagene ciloleucel
IND
Brexucabtagene autoleucel
Crizotinib
IND
Epcoritamab
Glofitamab
Ibrutinib
Mantle cell lymphoma (MCL), 1L.
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
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
Pirtobrutinib
Polatuzumab vedotin
IND
Tafasitamab
Zamtocabtagene autoleucel
Zanubrutinib
IND
Antithrombotic medications
Dabigatran
G
Proteïne C
IND
Asthma
Dupilumab
IND
Masitinib
Tezepelumab
Bacterial infections
Ceftobiprole
Ceftolozane / tazobactam
IND
Citric acid / lactic acid / potassium bitartrate
IND
Clindamycin
Dalbavancine
IND
Durlobactam / sulbactam
Eravacycline
Oritavancin diphosphate
IND
SER 109
Tebipenem
Bladder cancer
Avelumab
IND
Durvalumab
Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker.
IND
Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy
IND
Enfortumab vedotin
Erdafitinib
Inbakicept
Nivolumab
IND
Bowel diseases
Etrasimod
Etrolizumab
IND
Filgotinib
IND
Mirikizumab
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
Teduglutide
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
Vedolizumab
IND
Brain cancer
Dabrafenib / trametinib
Breast cancer
Abemaciclib
IND
Balixafortide
Elacestrant
Neratinib
IND
Olaparib
IND
Paclitaxel
Palbociclib
IND
Pembrolizumab
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
Tesetaxel
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.
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
Trastuzumab duocarmazine
Tucatinib
CLL
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
Ibrutinib
IND
Ublituximab
Zanubrutinib
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
CML
Asciminib
COPD
Ensifentrine
COVID-19
APN01
Anakinra
IND
Baricitinib
IND
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
Molnupiravir
PF-07321332 / ritonavir
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
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
Cervical cancer
Cemiplimab
IND
Lifileucel
Colon cancer
Eflornithine / sulindac
Cystic fibrosis
Lumacaftor / ivacaftor
IND
Dementia
Donanemab
Gantenerumab
Depression
Agomelatine
IND
Bupropion / dextromethorphan
Esketamine
IND
Diabetes
Bexagliflozine
Dulaglutide
IND
Exenatide
IND
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
Insulin lispro
IND
Insuline Icodec
Polyethylene glycol loxenatide
Regulatoire T-cellen (TREGS)
Sotagliflozine
IND
Teplizumab
Tirzepatide
Duchenne
Fordadistrogene movaparvovec
Givinostat
Golodirsen
Vamorolone
Viltolarsen
Epilepsy
Cannabidiol
IND
Fenfluramine
IND
Ganaxolone
Lacosamide
IND
Eye 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
Avacincaptad pegol
Faricimab
Treatment of neovascular (wet) age-related macular degeneration (nAMD).
Treatment of visual impairment due to diabetic macular oedema (DME).
Lenadogene nolparvovec
Pegcetacoplan
Perfluorohexyloctane
Phentolamine
Polihexanide
Ranibizumab
Wet age-related macular degeneration (AMD).
BS
Treatment of neovascular age-related macular degeneration (AMD)
Wet age-related macular degeneration (AMD)
BS
Reproxalap
Sepofarsen
Fungal infections
Ibrexafungerp
Oteseconazole
Rezafungin
HIV
Doravirine / lamivudine / tenofovirdisoproxil
IND
Lenacapavir
Raltegravir
BS
UB 421
Head and neck cancer
Pembrolizumab
IND
Tislelizumab
IND
Headache
Atogepant
Dihydroergotamine
Eptinezumab
Lasmiditan
Meloxicam / rizatriptan
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
Hemostasis promoting medication
Emicizumab
IND
Eptacog alfa (activated)
BS
Eptacog beta (activated)
Etranacogene dezaparvovec
Fidanacogene elaparvovec
Valoctocogene roxaparvovec
Indolent non-Hodgkin’s lymphoma
Axicabtagene ciloleucel
IND
Hypericin
Lacutamab
Mosunetuzumab
Parsaclisib
Tisagenlecleucel-T
IND
Infectious diseases other
Baloxavir marboxil
IND
Cefepime / Enmetazobactam
Fluticasone propionate
Kidney cancer
Cabozantinib
IND
Ilixadencel
Lenvatinib
IND
Pembrolizumab
Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC).
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
Tivozanib
IND
Lipid-lowering medications
Bempedoic acid
Evinacumab
Liver cancer
Atezolizumab
IND
Durvalumab
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
Lenvatinib
IND
Pembrolizumab
IND
Tremelimumab
IND
Liver diseases
Arachidyl amido cholanoic acid
Maralixibat
Seladelpar
Lung cancer
Adagrasib
Amivantamab
Atezolizumab
IND
Avelumab
IND
Cabozantinib
IND
Capmatinib
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
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
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
Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
IND
Ensartinib
Lenvatinib
IND
Lurbinectedin
Mobocertinib
Nivolumab
IND
OSE-2101
Pembrolizumab
IND
Pralsetinib
Selpercatinib
IND
Sintilimab
Sotorasib
Tepotinib
Tislelizumab
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 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 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
Toripalimab
Trastuzumab deruxtecan
IND
Tremelimumab
Trilaciclib
Lung diseases other
Benralizumab
IND
Gefapixant
Nintedanib
IND
Pamrevlumab
Pirfenidone
IND
Riociguat
IND
tocilizumab
IND
Metabolic diseases
ALXN1840
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
Cipaglucosidase alfa / miglustat
Empagliflozine
IND
Fexapotide
Fezolinetant
Fosdenopterin
Leriglitazone
Liraglutide
IND
Lixivaptan
Lonafarnib
Octreotide
Olenasufligene relduparvovec
Olipudase alfa
Palovarotene
Pariglasgene brecaparvovec
Pegunigalsidase alfa
RGX-121
Reloxaliase
Somapacitan
Somatrogon
Sparsentan
TransCon PTH (palopegteriparatide)
Multiple Myeloma
Belantamab mafodotin
IND
Carfilzomib
IND
Ciltacabtagene autoleucel
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
Elranatamab
Idecabtagene vicleucel
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
Ixazomib
IND
Melphalan flufenamide
IND
Pomalidomide
IND
Selinexor
IND
Teclistamab
Thalidomide
G
Venetoclax
IND
Zevorcabtagene autoleucel
Multiple sclerosis
Dimethyl fumarate
IND
Natalizumab
BS
Teriflunomide
Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
G
Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
G
Ublituximab
Muscular diseases other
Bidridistrogene xeboparvovec
Dantroleen
G
Daxibotulinumtoxine A
Deoxythymidine / deoxycytidine
Di-deuterated ethyl linoleate
Efgartigimod
Omaveloxolone
Ravulizumab
IND
Rozanolixizumab
Satralizumab
IND
Zilucoplan
Myeloproliferative disorders
Bomedemstat
Momelotinib
Navitoclax
Neuroendocrine cancer
Selumetinib
Surufatinib
Neurological disorders other
Cannabidiol
Clazosentan
Eladocagene exuparvovec
Inebilizumab
Ravulizumab
IND
Satralizumab
Tiratricol
Tominersen
Trofinetide
Vutrisiran
Oncology other
Afamitresgene autoleucel
Dostarlimab
Durvalumab
IND
Efbemalenograstim alfa
Erdafitinib
Futibatinib
Glucarpidase
Infigratinib
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
Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab.
IND
Lipegfilgrastim
IND
NY-ESO-1 autologous engineered TCR-T cells
Nirogacestat
Pembrolizumab
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, 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
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
indication for treatment with pembrolizumab plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma
IND
Selinexor
IND
Sodium thiosulfate
Tebentafusp
Tislelizumab
2L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
Other chronic immune diseases
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
Berotralstat
Budesonide modified released capsule
Canakinumab
IND
Coacillium topical
Dupilumab
IND
FCR 001
Leniolisib
Marnetegragene autotemcel
Mavorixafor
Ritlecitinib
Sizavaleucel
Sutimlimab
Voclosporin
Vonoprazan
Other hematology
Lenzilumab
Other medication for cardiovascular diseases
Angiotensin II
Dapagliflozine
IND
Etripamil
Icosapent ethyl
Macitentan
IND
Macitentan / tadalafil
Mavacamten
Neoatricon (dopamine)
Omecamtiv mecarbil
Rexlemestrocel-L
Rilonacept
Sotagliflozine
IND
Sotatercept
Tadalafil
IND
Treprostinil
G
Valsartan / sacubutril
IND
Other metabolism and Endocrinology
Abaloparatide
Treatment of osteoporosis in postmenopausal women at increased risk of fracture
Treatment of osteoporosis.
Alpelisib
Burosumab
IND
Corifollitropin alfa
IND
Ganirelix
G
Linzagolix
IND
Ospemifene
IND
Pegzilarginase
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
Vosoritide
Other non-oncological hematological medications
Crizanlizumab
Danicopan
Daprodustat
Eculizumab
BS
Efgartigimod
Eltrombopag
IND
Eptacog alfa
IND
Exagamglogene autotemcel
Ferumoxytol
Horse anti-human T lymphocyte immunoglobulin
Iptacopan
Luspatercept
IND
Methoxy polyethylene glycol-epoetin beta
IND
Mitapivat
Mozafancogene autotemcel
Pegcetacoplan
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
UM171
Vadadustat
Voxelotor
Other psychiatry
Dexmedetomidine
Ovarian cancer
Dostarlimab
IND
Mirvetuximab soravtansine
Rucaparib
IND
Pain
Bupivacaine
Buprenorfine
IND
Fasinumab
SDN037
Parasitic infections
Lotilaner
Parkinson's
Levodopa / carbidopa
Prostate cancer
Darolutamide
IND
Degarelix
G
Enzalutamide
IND
Gozetotide
Leuprolide mesylate
Lutetium (177lu) vipivotide tetraxetan
Masitinib
Niraparib / abiraterone
Olaparib
IND
Pembrolizumab
IND
Relugolix
Talazoparib
IND
Rheumatism
Anifrolumab
Baricitinib
IND
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
Cyclobenzaprine hydrochloride
Sarilumab
IND
Secukinumab
IND
Tocilizumab
BS
Upadacitinib
IND
SMA
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
Schizophrenia, psychosis, bipolar disorder
Roluperidon
Skin cancer
Darleukin fibromun
Ipilimumab
IND
Lenvatinib
IND
Lifileucel
Nivolumab
IND
Pembrolizumab
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
Relatlimab / nivolumab
Tavokinogene telseplasmid
Skin diseases
Baricitinib
IND
Beremagene geperpavec
Berkenschorsextract
Concentrate of proteolytic enzymes enriched in bromelain
IND
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 indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
IND
Lebrikizumab
Regenerative Skin Tissue
Roflumilast topicaal
Ruxolitinib phosphate
Secukinumab
IND
Sirolimus
G
Spesolimab
Tralokinumab
IND
Sleep disorders
Daridorexant
JZP-258
Natriumoxybaat controlled release
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
Stem cell transplants
Narsoplimab
Omidubicel
Plerixafor
G
Ruxolitinib
IND
Tabelecleucel
Treosulfan
IND
UM171
Stomach cancer
Catumaxomab
Pembrolizumab
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 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
Ripretinib
Tislelizumab
IND
Trastuzumab deruxtecan
IND
Zolbetuximab
Thyroid cancer
Cabozantinib
IND
Pralsetinib
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
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
Tumour agnostic medication
Selpercatinib
IND
Unknown
Diazoxide choline (controlled-release tablet)
Levonorgestrel
G
Linzagolix
Lonapegsomatropin
Lumasiran
Mirabegron
IND
Olopatadine / mometasone
Pirfenidone
G
Relugolix
IND
Relugolix / estradiol / norethisteronen
Sofpironium bromide
Vibegron
Viral infections other
Bizalimogene ralaplasmid
Bulevirtide
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
Maribavir
Nirsevimab
Posoleucel
Tenofovir alafenamide
IND
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