| Name |
Azzalure 125 Speywood jedinica, prašak za otopinu za injekciju |
| Marketing Authorisation Number |
HR-H-020838433 |
| Active Substance |
neurotoksin Clostridium Botulinum tip A - hemaglutininski kompleks |
| Composition |
125 Speywood jedinica botulinskog toksina tipa A u prašku u bočici |
| Pharmaceutical Form |
prašak za otopinu za injekciju |
| Manufacturer |
Ipsen Manufacturing Ireland Ltd., Blanchardstown, Irska |
| Marketing Authorisation Holder |
Ipsen Pharma, 70 Rue Balard, Pariz, Francuska |
| Marketing Authorisation Date |
25.07.2023 |
| MA Period of Validity |
25.07.2028 |
| Classification Number |
UP/I-530-09/23-01/88 |
| Registration Number |
381-12-01/154-23-07 |
| 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
|
| Summary of risk management plan |
download |
