Alkagin 2,5 g/5 ml otopina za injekciju/infuziju

Name	Alkagin 2,5 g/5 ml otopina za injekciju/infuziju
Former Name	Alkagin 2,5 g/5 ml otopina za injekciju
Marketing Authorisation Number	HR-H-247007014
Active Substance	metamizolnatrij hidrat
Composition	5 ml otopine za injekciju (1 ampula) sadrži 2,5 g metamizolnatrija hidrata
Pharmaceutical Form	Otopina za injekciju / infuziju
Manufacturer	Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija
Marketing Authorisation Holder	Alkaloid d.o.o., Slavonska avenija 6 A, Zagreb, Hrvatska
Marketing Authorisation Date	20.09.2017
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/16-02/458
Registration Number	381-12-01/70-17-04
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	N02BB02
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
50 ampula s 5 ml otopine, u kutiji	HR-H-247007014-01	Marketed	No shortage

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o riziku od oštećenja jetre uzrokovanog lijekovima koji sadrže metamizol	15.12.2020	Alkaloid d.o.o, Pliva Hrvatska d.o.o
Pismo zdravstvenim radnicima o važnim mjerama za minimizaciju ozbiljnih ishoda poznatog rizika od agranulocitoze uz primjenu lijekova koji sadrže metamizol	09.12.2024	Alkaloid d.o.o., Pliva Hrvatska d.o.o., Bausch Health Poland sp. z.o.o