Gadovist 1,0 mmol/ml otopina za injekciju u napunjenoj štrcaljki/ulošku

Name	Gadovist 1,0 mmol/ml otopina za injekciju u napunjenoj štrcaljki/ulošku
Marketing Authorisation Number	HR-H-860656850
Active Substance	gadobutrol
Composition	1 ml otopine za injekciju sadrži 604,72 mg gadobutrola (što odgovara 1,0 mmol gadobutrola, odnosno 157,25 mg gadolinija)
Pharmaceutical Form	otopina za injekciju u napunjenoj štrcaljki
Manufacturer	Bayer AG, Berlin, Njemačka
Marketing Authorisation Holder	Bayer d.o.o., Radnička cesta 80, Zagreb, Hrvatska
Marketing Authorisation Date	13.02.2019
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/18-02/302
Registration Number	381-12-01/30-19-02
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to restricted medical prescription
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	V08CA09
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 napunjena štrcaljka s 5 ml otopine, u kutiji	HR-H-860656850-01	Never marketed	-
5 napunjenih štrcaljki s 5 ml otopine, u kutiji	HR-H-860656850-02	Never marketed	-
1 napunjena štrcaljka s 7,5 ml otopine, u kutiji	HR-H-860656850-03	Never marketed	-
5 napunjenih štrcaljki s 7,5 ml otopine, u kutiji	HR-H-860656850-04	Marketed	No shortage
1 napunjena štrcaljka s 10 ml otopine, u kutiji	HR-H-860656850-05	Never marketed	-
5 napunjenih štrcaljki s 10 ml otopine, u kutiji	HR-H-860656850-06	Never marketed	-
1 napunjena štrcaljka s 15 ml otopine, u kutiji	HR-H-860656850-07	Never marketed	-
5 napunjenih štrcaljki s 15 ml otopine, u kutiji	HR-H-860656850-08	Never marketed	-
1 napunjena štrcaljka s 20 ml otopine, u kutiji	HR-H-860656850-09	Never marketed	-
5 napunjenih štrcaljki s 20 ml otopine, u kutiji	HR-H-860656850-10	Never marketed	-
1 uložak s 15 ml otopine, u kutiji	HR-H-860656850-11	Never marketed	-
5 uložaka s 15 ml otopine, u kutiji	HR-H-860656850-12	Never marketed	-
1 uložak s 20 ml otopine, u kutiji	HR-H-860656850-13	Never marketed	-
5 uložaka s 20 ml otopine, u kutiji	HR-H-860656850-14	Never marketed	-
1 uložak s 30 ml otopine, u kutiji	HR-H-860656850-15	Never marketed	-
5 uložaka s 30 ml otopine, u kutiji	HR-H-860656850-16	Never marketed	-

Medicinal Products