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Metabolism and Endocrinology
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Allogeneic modified cell therapy
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Other, see general comments
PARP inhibitor
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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
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IND
Biosimilars / generics
BS
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Diabetes
Dasiglucagon
Deudomperidone
Empagliflozine
IND
Insulin Icodec
Insulin oral
Regulatoire T-cellen (TREGS)
Teplizumab
Liver diseases
Arachidyl amido cholanoic acid
Elafibranor
Maralixibat
Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older
IND
Obeticholic acid
Odevixibat
IND
Resmetirom
Seladelpar
Metabolic diseases
Afamelanotide
IND
Avalglucosidase alfa
Cipaglucosidase alfa
Dasiglucagon
IND
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
Palopegteriparatide
Paltusotine
Pegunigalsidase alfa
RGX-121
Sepiapterin
Somapacitan
Sparsentan
Tiomolibdate choline
Other metabolism and Endocrinology
Alpelisib
Autologous human chondrocytes in vitro expanded
C-type natriuretic peptide prodrug
Copper histidine
Linzagolix
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
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.
IND
Op dit moment heeft oraal semaglutide reeds een indicatie voor diabetes. De aan te vragen indicatie uitbreiding zal slaan op het behandelen van obesitas.
IND
Setmelanotide
IND
Setrusumab
Tirzepatide
IND
Vosoritide
IND
Unknown
Mirabegron
IND
Olezarsen
Relugolix / estradiol / norethisterone acetaat
IND
Vibegron
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