Ambrisentan AOP 10 mg filmom obložene tablete
| Name | Ambrisentan AOP 10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-194978440 |
| Active Substance | ambrisentan |
| Composition | svaka filmom obložena tableta sadrži 10 mg ambrisentana |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Genepharm S.A., Pallini Attiki, Grčka
Delorbis Pharmaceuticals Ltd, Lefkosia, Ergates, Cipar |
| Marketing Authorisation Holder | AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, Beč, Austrija |
| Marketing Authorisation Date | 30.11.2020 |
| MA Period of Validity | 30.11.2025 |
| MA Revocation Date | 07.01.2025* |
| Classification Number | UP/I-530-09/19-01/80 |
| Registration Number | 381-12-01/14-20-04 |
| 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 | C02KX02 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
