Airing 0,120 mg/0,015 mg tijekom 24 sata, sustav za isporuku u rodnicu
| Name | Airing 0,120 mg/0,015 mg tijekom 24 sata, sustav za isporuku u rodnicu |
|---|---|
| Marketing Authorisation Number | HR-H-431895168 |
| Active Substance | etonogestrel etinilestradiol |
| Composition | 1 sustav za isporuku u rodnicu sadrži 11,7 mg etonogestrela i 2,7 mg etinilestradiola; tijekom razdoblja od 3 tjedna sustav otpušta prosječno 0,120 mg etonogestrela i 0,015 mg etinilestradiola u 24 sata |
| Pharmaceutical Form | Sustav za isporuku u rodnicu |
| Manufacturer | Mithra Pharmaceuticals CDMO S.A., Felmalle, Belgija |
| Marketing Authorisation Holder | Aicore Life Sciences B.V., Boxbergerweg 119, Diepenveen, Overijssel, Nizozemska |
| Marketing Authorisation Date | 30.10.2023 |
| MA Period of Validity | 30.10.2028 |
| MA Revocation Date | 16.05.2025* |
| Classification Number | UP/I-530-09/20-01/177 |
| Registration Number | 381-12-01/154-23-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | G02BB01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
