The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
Name
Signifor
Active Substance
pasireotid
Prescription
Medicinal product subject to medical prescription
Type of prescription
Medicinal product subject to restricted medical prescription (otopina za injekciju, prašak i otapalo za suspenziju za injekciju)
Distribution
Supply through pharmacies (community)
ATC Code
H01CB05
Marketing status
Marketed
Shortage status
No shortage
Summary of product characteristics (SmPC), labelling and package leaflet (PL)
Signifor 20 mg prašak i otapalo za suspenziju za injekciju, 1 bočica s praškom i 1 napunjena štrcaljka s 2 ml otapala + 1 adapter za bočicu + 1 igla, u kutiji
EU/1/12/753/013
Never marketed
-
Signifor 40 mg prašak i otapalo za suspenziju za injekciju, 1 bočica s praškom i 1 napunjena štrcaljka s 2 ml otapala + 1 adapter za bočicu + 1 igla, u kutiji
EU/1/12/753/014
Marketed
No shortage
Signifor 60 mg prašak i otapalo za suspenziju za injekciju, 1 bočica s praškom i 1 napunjena štrcaljka s 2 ml otapala + 1 adapter za bočicu + 1 igla, u kutiji
EU/1/12/753/016
Marketed
No shortage
Signifor 10 mg prašak i otapalo za suspenziju za injekciju, 1 bočica s praškom i 1 napunjena štrcaljka s 2 ml otapala + 1 adapter za bočicu + 1 igla, u kutiji
EU/1/12/753/018
Marketed
No shortage
Signifor 30 mg prašak i otapalo za suspenziju za injekciju, 1 bočica s praškom i 1 napunjena štrcaljka s 2 ml otapala + 1 adapter za bočicu + 1 igla, u kutiji