Gadovist 1,0 mmol/ml otopina za injekciju

Name	Gadovist 1,0 mmol/ml otopina za injekciju
Marketing Authorisation Number	HR-H-640080282
Active Substance	gadobutrol
Composition	1 ml otopine za injekciju sadrži 604,72 mg gadobutrola (što odgovara 1,0 mmol gadobutrola koji sadrži 157,25 mg gadolinija)
Pharmaceutical Form	otopina za injekciju
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-530-09/18-02/301
Registration Number	381-12-01/30-19-04
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 bočica s 2 ml otopine, u kutiji	HR-H-640080282-01	Never marketed	-
3 bočice s 2 ml otopine, u kutiji	HR-H-640080282-02	Never marketed	-
1 bočica s 7,5 ml otopine, u kutiji	HR-H-640080282-03	Never marketed	-
10 bočica s 7,5 ml otopine, u kutiji	HR-H-640080282-04	Never marketed	-
1 bočica s 15 ml otopine, u kutiji	HR-H-640080282-05	Marketed	No shortage
10 bočica s 15 ml otopine, u kutiji	HR-H-640080282-06	Never marketed	-
1 bočica s 30 ml otopine, u kutiji	HR-H-640080282-07	Never marketed	-
10 bočica s 30 ml otopine, u kutiji	HR-H-640080282-08	Marketed	No shortage
1 boca s 65 ml otopine, u kutiji	HR-H-640080282-09	Never marketed	-
10 boca s 65 ml otopine, u kutiji	HR-H-640080282-10	Never marketed	-

Medicinal Products