Copaxone 40 mg/ml otopina za injekciju u napunjenoj štrcaljki

Name	Copaxone 40 mg/ml otopina za injekciju u napunjenoj štrcaljki
Marketing Authorisation Number	HR-H-304476486
Active Substance	glatirameracetat
Composition	jedan ml otopine za injekciju u napunjenoj štrcaljki sadrži 40 mg glatirameracetata, što odgovara 36 mg glatiramera
Pharmaceutical Form	otopina za injekciju u napunjenoj štrcaljki
Manufacturer	Norton Healthcare Limited T/A Ivax Pharmaceuticals UK, Runcorn, Cheshire, Ujedinjeno Kraljevstvo Merckle GmbH, Ulm, Njemačka Actavis Group PTC ehf., Hafnarfjoerdur, Island
Marketing Authorisation Holder	Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date	21.10.2019
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/19-02/60
Registration Number	381-12-01/38-19-04
Prescription	Medicinal product subject to medical prescription
Type of prescription	ograničeni recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	L03AX13
Marketing status	stavljeno u promet
Shortage status	nema nestašice
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
3 napunjene štrcaljke s 1 ml otopine , u kutij	HR-H-304476486-01	nije stavljeno u promet	-
12 napunjenih štrcaljki s 1 ml otopine , u kutiji	HR-H-304476486-02	stavljeno u promet	nema nestašice
12 napunjenih štrcaljki s 1 ml otopine u kutiji, 3 pakiranja, u kutiji	HR-H-304476486-03	nije stavljeno u promet	-
36 napunjenih štrcaljki s 1 ml otopine, u kutiji	HR-H-304476486-04	-	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o anafilaktičkim reakcijama koje mogu nastupiti mjesecima do godinama nakon početka primjene lijekova koji sadrže glatirameracetat	20.08.2024	Pliva Hrvatska d.o.o., Zentiva, k.s.