Actilyse 50 mg prašak i otapalo za otopinu za injekciju/infuziju
| Name | Actilyse 50 mg prašak i otapalo za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-191255719 |
| Active Substance | alteplaza |
| Composition | 1 bočica s praškom sadrži 50 mg alteplaze (što odgovara 29 000 000 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, Zagreb, Hrvatska |
| Marketing Authorisation Date | 08.11.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/512 |
| Registration Number | 381-12-01/70-18-09 |
| 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 | B01AD02 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
