| Name |
Bocouture 100 jedinica prašak za otopinu za injekciju |
| Marketing Authorisation Number |
HR-H-311134880 |
| Active Substance |
neurotoksin Clostridium botulinum tip A (150 kDa), ne sadrži proteinske komplekse |
| Composition |
jedna bočica sadrži 100 jedinica botulinskog toksina tipa A (150 kD), ne sadrži proteinske komplekse*. *Botulinski toksin tip A, pročišćen iz kultura Clostridium botulinum (soj Hall) |
| Pharmaceutical Form |
prašak za otopinu za injekciju |
| Manufacturer |
Merz Pharma GmbH & Co. KgaA, Reinheim, Njemačka |
| Marketing Authorisation Holder |
Merz Pharmaceuticals GmbH, Eckenheimer Landstrasse 100, Frankfurt/Main, Njemačka |
| Marketing Authorisation Date |
16.07.2021 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/21-02/45 |
| Registration Number |
381-12-01/154-21-02 |
| 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 |
M03AX01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
