Clariscan 0,5 mmol/ml otopina za injekciju u napunjenoj štrcaljki

Name	Clariscan 0,5 mmol/ml otopina za injekciju u napunjenoj štrcaljki
Marketing Authorisation Number	HR-H-420418028
Active Substance	meglumingadoterat
Composition	1 ml otopine za injekciju sadrži 279,32 mg gadoteratne kiseline (u obliku gadoterat meglumina) što odgovara 0,5 mmol
Pharmaceutical Form	otopina za injekciju u napunjenoj štrcaljki
Manufacturer	GE Healthcare AS, Oslo, Norveška
Marketing Authorisation Holder	GE Healthcare AS, Nycoveien 1, Oslo, Norveška
Marketing Authorisation Date	09.03.2022
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/21-02/59
Registration Number	381-12-01/70-22-02
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	V08CA02
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 napunjena štrcaljka s 10 ml otopine, u kutiji	HR-H-420418028-01	Never marketed	-
10 napunjenih štrcaljki s 10 ml otopine, u kutiji	HR-H-420418028-02	Not marketed	-
1 napunjena štrcaljka s 15 ml otopine, u kutiji	HR-H-420418028-03	Never marketed	-
10 napunjenih štrcaljki s 15 ml otopine, u kutiji	HR-H-420418028-04	Marketed	No shortage
1 napunjena štrcaljka s 20 ml otopine, u kutiji	HR-H-420418028-05	Never marketed	-
10 napunjenih štrcaljki s 20 ml otopine, u kutiji	HR-H-420418028-06	Never marketed	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o najnovijim preporukama za gadolinijska kontrastna sredstva	04.12.2017	Bayer d.o.o., Bracco Imaging S.p.A., GE Healthcare d.o.o. i Pharmacol d.o.o.