Actilyse 20 mg prašak i otapalo za otopinu za injekciju/infuziju
Name | Actilyse 20 mg prašak i otapalo za otopinu za injekciju/infuziju |
---|---|
Marketing Authorisation Number | HR-H-676368257 |
Active Substance | alteplaza |
Composition | jedna bočica s praškom sadrži 20 mg alteplaze (što odgovara 11 600 000 IU) |
Pharmaceutical Form | Prašak i otapalo za otopinu za injekciju / infuziju |
Manufacturer | Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Njemačka Boehringer Ingelheim France, Pariz, Francuska |
Marketing Authorisation Holder | Boehringer Ingelheim Zagreb d.o.o., Radnička cesta 75, 10000 Zagreb, Zagreb, Hrvatska |
Marketing Authorisation Date | 08.11.2018 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/17-02/511 |
Registration Number | 381-12-01/70-18-09 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B01AD02 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |