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 |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
M03AX01 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|