Name |
EMALT 10 mg raspadljive tablete za usta |
Marketing Authorisation Number |
HR-H-545379920 |
Active Substance |
rizatriptanbenzoat |
Composition |
jedna raspadljiva tableta za usta sadrži 10 mg rizatriptana (u obliku rizatriptanbenzoata) |
Pharmaceutical Form |
raspadljiva tableta za usta |
Packaging [MA Number for Packaging] |
6 tableta u blisteru, u kutiji [HR-H-545379920-01]
|
Manufacturer |
Glenmark Pharmaceuticals s.r.o., Vysoké Mýto, Češka |
Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
Marketing Authorisation Date |
06.04.2021 |
MA Period of Validity |
06.04.2026 |
Classification Number |
UP/I-530-09/19-01/49 |
Registration Number |
381-12-01/154-21-12 |
Prescription |
na recept |
Type of prescription |
ponovljivi recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
N02CC04 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |