Name |
Letybo 50 jedinica prašak za otopinu za injekciju |
Marketing Authorisation Number |
HR-H-413273619 |
Active Substance |
neurotoksin Clostridium botulinum tip A (900 kDa) |
Composition |
jedna bočica sadrži 50 jedinica botulinskog toksina tipa A koji proizvodi Clostridium botulinum. Nakon rekonstitucije svakih 0,1 ml otopine sadrži 4 jedinice. |
Pharmaceutical Form |
prašak za otopinu za injekciju |
Manufacturer |
Croma-Pharma GmbH, Leobendorf, Austrija |
Marketing Authorisation Holder |
Croma-Pharma GmbH, Industriezeile 6, Leobendorf, Niederoesterreich, Austrija |
Marketing Authorisation Date |
15.11.2023 |
MA Period of Validity |
15.11.2028 |
Classification Number |
UP/I-530-09/23-01/217 |
Registration Number |
381-12-01/171-23-12 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
M03AX01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |