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Published on
6 June 2023
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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
ALL
ARI-0001
Brexucabtagene autoleucel
IND
Crisantaspase
Obecabtagene autoleucel
Ponatinib
IND
ALS
Masitinib
Sodium phenylbutyrate / ursodoxicoltaurine
Tofersen
IND
AML / MDS
Decitabine / cedazuridine
Eprenetapopt
Gilteritinib
IND
Iomab-B
Ivosidenib
Magrolimab
Quizartinib
Aggressive non-Hodgkin?s lymphoma
Acalabrutinib
IND
Axicabtagene ciloleucel
IND
Crizotinib
IND
Epcoritamab
Glofitamab
Ibrutinib
IND
Lisocabtagene maraleucel
IND
Loncastuximab tesirine
Pirtobrutinib
Polatuzumab vedotin
IND
Tafasitamab
Zamtocabtagene autoleucel
Zanubrutinib
IND
Antithrombotic medications
Aprocitentan
Dabigatran
G
Proteïne C
IND
Asthma
Masitinib
Tezepelumab
Bacterial infections
Bezlotoxumab
Ceftobiprole
Citric acid / lactic acid / potassium bitartrate
IND
Clindamycin
Dalbavancine
IND
Durlobactam / sulbactam
Eravacycline
Gepotidacin
Oritavancin diphosphate
IND
Ridinilazole
SER 109
Tebipenem
Bladder cancer
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
IND
Erdafitinib
Inbakicept
Nivolumab
IND
Bowel diseases
Budesonide
Etrasimod
Etrolizumab
IND
Filgotinib
IND
Glepaglutide
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
G
Brain cancer
Dabrafenib / trametinib
Breast cancer
Abemaciclib
IND
Atezolizumab
IND
Balixafortide
Capivasertib
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
Extension of indication to include treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
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.
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
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 HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
IND
Trastuzumab duocarmazine
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
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
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 adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
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
Cadonilimab
Cemiplimab
IND
Lifileucel
Colon cancer
Eflornithine / sulindac
Fruquintinib
Trifluridine / tipiracil
Cystic fibrosis
Lumacaftor / ivacaftor
IND
Dementia
Blarcamesine
Donanemab
Hydromethylthionine mesylaat
Lecanemab
Depression
Agomelatine
IND
Bupropion / dextromethorphan
Diabetes
Bexagliflozine
Dasiglucagon
Dulaglutide
IND
Empagliflozine
IND
Finerenon
IND
Insulin Icodec
Insulin lispro
IND
Polyethylene glycol loxenatide
Regulatoire T-cellen (TREGS)
Teplizumab
Tirzepatide
Duchenne
Fordadistrogene movaparvovec
Givinostat
Golodirsen
Losmapimod
Vamorolone
Viltolarsen
Epilepsy
Cannabidiol
IND
Fenfluramine
IND
Ganaxolone
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
Bevacizumab-vikg
Bimatoprost
Botaretigene sparoparvovec
Faricimab
Treatment of neovascular (wet) age-related macular degeneration (nAMD).
Treatment of visual impairment due to diabetic macular oedema (DME).
Laruparetigene zosaparvovec
Lenadogene nolparvovec
Pegcetacoplan
IND
Perfluorohexyloctane
Phentolamine
Polihexanide
Ranibizumab
Treatment of neovascular age-related macular degeneration (AMD)
Wet age-related macular degeneration (AMD)
BS
Reproxalap
Sepofarsen
Varenicline
Fungal infections
Oteseconazole
Rezafungin
HIV
Raltegravir
BS
Semzuvolimab
Head and neck cancer
Atezolizumab
IND
Leukocyte interleukin
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 beta (activated)
Etranacogene dezaparvovec
Fidanacogene elaparvovec
Nonacog beta pegol
IND
Peboctocogene camaparvovec
Valoctocogene roxaparvovec
Vonicog alfa
IND
Hodgkin's lymphoma
Brentuximab vedotin
IND
Indolent non-Hodgkin?s lymphoma
Axicabtagene ciloleucel
IND
Epcoritamab
IND
Hypericin
Ibrutinib
IND
Lacutamab
Mosunetuzumab
Tisagenlecleucel-T
IND
Zanubrutinib
IND
Infectious diseases other
Baloxavir marboxil
IND
Cefepime / Enmetazobactam
Cefepime/taniborbactam
Fluticasone propionate
Kidney cancer
Atezolizumab
IND
Belzutifan
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
Lipid-lowering medications
Alirocumab
IND
Bempedoic acid
Evinacumab
Liver cancer
Atezolizumab
IND
Durvalumab
Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.
IND
Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
IND
Tremelimumab
Liver diseases
Arachidyl amido cholanoic acid
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 2 months of age and older
IND
Obeticholic acid
Odevixibat
IND
Resmetirom
Seladelpar
Lung cancer
Adagrasib
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 subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
IND
Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
IND
Aumolertinib (mesilate)
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
LIBTAYO in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of 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
Domvanalimab
Durvalumab
Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.
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
Nintedanib
G
Nivolumab
IND
OSE-2101
Osimertinib
Osimertinib with platinum plus pemetrexed chemotherapy as first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
IND
Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
IND
Pembrolizumab
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
Extension of indication to include in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant, treatment of resectable stage II, IIIA, or IIIB (T3 4N2) non-small cell lung carcinoma in adults.
IND
Selpercatinib
IND
Serplulimab
Sugemalimab
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
IND
Trastuzumab deruxtecan
IND
Tremelimumab
Lung diseases other
Benralizumab
IND
Gefapixant
Nintedanib
IND
Pamrevlumab
Pirfenidone
IND
Riociguat
IND
Sotatercept
Tadalafil
IND
Tocilizumab
IND
Metabolic diseases
ALXN1840
Afamelanotide
IND
Avalglucosidase alfa
Bardoxolone Methyl
Cipaglucosidase alfa
Empagliflozine
IND
Fezolinetant
Fosdenopterin
Leriglitazone
Liraglutide
IND
Lonafarnib
Octreotide
Olenasufligene relduparvovec
Olipudase alfa
Palopegteriparatide
Palovarotene
Pegunigalsidase alfa
RGX-121
Somapacitan
Somatrogon
Sparsentan
Multiple Myeloma
Belantamab mafodotin
IND
Ciltacabtagene autoleucel
Daratumumab
IND
Elranatamab
Idecabtagene vicleucel
IND
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
Pepaxti, in combinatie met dexamethason, is geïndiceerd voor de behandeling van volwassen patiënten met multipel myeloom die minstens drie eerdere therapielijnen hebben gekregen, bij wie de ziekte refractair is voor ten minste één proteasoomremmer, één immunomodulerend middel, één antiCD38-monoklonaal antilichaam, en die tijdens of na hun laatste therapie ziekteprogressie vertoonden. Bij patiënten die eerder een autologe stamceltransplantatie hebben ondergaan, moet er tussen die transplantatie en de progressie ten minste drie jaar zijn verstreken.
IND
Extension of indication to include treatment of patients with Multiple Myeloma who have received at least two prior lines of therapies for PEPAXTI.
IND
Pomalidomide
G
Selinexor
IND
Talquetamab
Teclistamab
Thalidomide
G
Venetoclax
IND
Zevorcabtagene autoleucel
Multiple sclerosis
Natalizumab
BS
Ublituximab
Muscular diseases other
Bidridistrogene xeboparvovec
Dantroleen
G
Daxibotulinumtoxine A
Deoxythymidine / deoxycytidine
Di-deuterated ethyl linoleate
Eculizumab
Extension of indication to include treatment of paediatric patients aged 6 to less than 18 years with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.
IND
Extension of indication to include treatment of paediatric patients with refractory generalised myasthenia gravis (gMG).
IND
Efgartigimod
Omaveloxolone
Ravulizumab
IND
Rozanolixizumab
Satralizumab
IND
Zilucoplan
Myeloproliferative disorders
Avapritinib
IND
Bomedemstat
Momelotinib
Navitoclax
Pelabresib
Pemigatinib
IND
Neurological disorders other
Cannabidiol
Clazosentan
Eladocagene exuparvovec
Human normal immunoglobulin
IND
Inebilizumab
Ravulizumab
IND
Tiratricol
Tominersen
Trofinetide
Troriluzole
Vutrisiran
Oncology other
AL102
Afamitresgene autoleucel
Durvalumab
IND
Efbemalenograstim alfa
Erdafitinib
Futibatinib
Glucarpidase
Ivosidenib
Jodium (131I) omburtamab
Lenvatinib
IND
Melphalan hydrochloride
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 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
Retifanlimab
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)
Toripalimab
Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)
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”)
Other chronic immune diseases
Avapritinib
IND
Baricitinib
IND
Budesonide modified released capsule
Coacillium topical
Dupilumab
IND
FCR 001
Leniolisib
Lorecivivint
Marnetegragene autotemcel
Mavorixafor
Ritlecitinib
Sizavaleucel
Sutimlimab
Voclosporin
Other hematology
Lenzilumab
Luspatercept
IND
Obinutuzumab
IND
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
Valsartan / sacubitril
IND
Vericiguat
Other metabolism and Endocrinology
Abaloparatide
Treatment of osteoporosis in postmenopausal women at increased risk of fracture
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Alpelisib
Copper histidine
Linzagolix
IND
Ospemifene
IND
Pegzilarginase
Semaglutide
For weight management in people with obesity or who are overweight and have other related conditions.
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.
IND
Tirzepatide
IND
Vosoritide
IND
Other non-oncological hematological medications
Bentracimab
Concizumab
Hemofilie A en B zonder inhibitors
IND
Hemofilie A met inhibitors en hemofilie B met inhibitors
Crizanlizumab
Crovalimab
Danicopan
Daprodustat
Eculizumab
BS
Efanesoctocog alfa
Efgartigimod
Exagamglogene autotemcel
Ferumoxytol
Hydroxycarbamide
IND
Iptacopan
Luspatercept
IND
Methoxy polyethylene glycol-epoetin beta
IND
Mitapivat
Mozafancogene autotemcel
Pegcetacoplan
Paroxysmal nocturnal haemoglobinuria (PNH)
Extension of indication to include treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously treated with a complement inhibitor
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
UM171
Vadadustat
Voxelotor
Other psychiatry
Dexmedetomidine
Ovarian cancer
Dostarlimab
Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer")
IND
Extension of indication to include in combination with platinum -containing chemotherapy 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
IND
Mirvetuximab soravtansine
Rucaparib
IND
Pain
Bupivacaine
IND
Buprenorfine
IND
Difluprednate
Fasinumab
Parasitic infections
Lotilaner
Parkinson's
Levodopa / carbidopa
Prostate cancer
Atezolizumab
IND
Darolutamide
IND
Degarelix
G
Enzalutamide
IND
Gozetotide
Lutetium (177lu) vipivotide tetraxetan
Masitinib
Niraparib / abirateron
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.
IND
treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone
IND
Talazoparib
IND
Rheumatism
Baricitinib
IND
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.
IND
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).
IND
Cyclobenzaprine hydrochloride
Sarilumab
IND
Tocilizumab
BS
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
Ulotaront
Skin cancer
Darleukin fibromun
Ipilimumab
IND
Lenvatinib
IND
Lifileucel
Nivolumab
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
Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
IND
Pembrolizumab
IND
Relatlimab / nivolumab
Tavokinogene telseplasmid
Skin diseases
Baricitinib
IND
Beremagene geperpavec
Berkenschorsextract
Concentrate of proteolytic enzymes enriched in bromelain
IND
Dabocemagene autoficel
Delgocitinib
Deucravacitinib
Difelikefalin
Dupilumab
Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
IND
Extension of indication to include treatment of severe atopic dermatitis in paediatric patients from 6 months to <6 years of age.
IND
Methotrexaat
Piclidenoson
Regenerative Skin Tissue
Roflumilast topicaal
Ruxolitinib phosphate
Secukinumab
IND
Sirolimus
Spesolimab
Tralokinumab
IND
Sleep disorders
Daridorexant
Natriumoxybaat controlled release
Pitolisant
IND
Stem cell transplants
Abatacept
IND
ECT-001-CB
Narsoplimab
Omidubicel
Plerixafor
G
Tabelecleucel
Treosulfan
IND
Stomach cancer
Catumaxomab
Domvanalimab
Nivolumab
IND
Pembrolizumab
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
IND
Extension of indication to include in combination with chemotherapy the first -line treatment of locally advanced unresectable or metastatic HER2 -negative gastric or gastrooesophageal junction adenocarcinoma in adults.
IND
Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
IND
Tislelizumab
IND
Trastuzumab deruxtecan
IND
Zolbetuximab
Thyroid cancer
Selpercatinib
Extension of indication to include the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer in the first-line setting for Retsevmo.
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
Dasatinib
IND
Diazoxide choline (controlled-release tablet)
Eplontersen
Ibrutinib
IND
Levonorgestrel
G
Linzagolix
Lonapegsomatropin
Lumasiran
Mirabegron
IND
Pirfenidone
G
Relugolix / estradiol / norethisterone acetaat
IND
Relugolix / estradiol / norethisteronen
Sofpironium bromide
Tagraxofusp
Vibegron
Viral infections other
Bizalimogene ralaplasmid
Bulevirtide
Letermovir
Extension of indication to include treatment of prophylaxis of cytomegalovirus in kidney transplant recipients (KTR) for PREVYMIS.
IND
Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant
IND
Lonafarnib
IND
Maribavir
Nirsevimab
Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
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
IND
Posoleucel
Tenofovir alafenamide
IND
Naar boven
National Health Care Institute
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