| 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 |
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 |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
