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	ograničeni recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	V08CA02
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
1 napunjena štrcaljka s 10 ml otopine, u kutiji	HR-H-420418028-01	nije stavljeno u promet	-
10 napunjenih štrcaljki s 10 ml otopine, u kutiji	HR-H-420418028-02	trajni prekid opskrbe	-
1 napunjena štrcaljka s 15 ml otopine, u kutiji	HR-H-420418028-03	nije stavljeno u promet	-
10 napunjenih štrcaljki s 15 ml otopine, u kutiji	HR-H-420418028-04	stavljeno u promet	nema nestašice
1 napunjena štrcaljka s 20 ml otopine, u kutiji	HR-H-420418028-05	nije stavljeno u promet	-
10 napunjenih štrcaljki s 20 ml otopine, u kutiji	HR-H-420418028-06	nije stavljeno u promet	-

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.