Posakonazol Mylan 100 mg želučanootporne tablete
| Name | Posakonazol Mylan 100 mg želučanootporne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-397543032 |
| Active Substance | posakonazol |
| Composition | jedna želučanootporna tableta sadrži 100 mg posakonazola |
| Pharmaceutical Form | želučanootporna tableta |
| Manufacturer | Delorbis Pharmaceuticals Ltd, Lefkosia, Ergates, Cipar
Medis International A.S., Bolatice, Češka |
| Marketing Authorisation Holder | Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 06.10.2021 |
| MA Period of Validity | 21.11.2024 |
| Classification Number | UP/I-530-09/18-01/76 |
| Registration Number | 381-12-01/154-21-21 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J02AC04 |
| Medicinal product marketed in the Croatia | Privremeni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
