Etonogestrel/Etinilestradiol Mithra 0,120 mg/0,015 mg tijekom 24 sata, sustav za isporuku u rodnicu
| Name | Etonogestrel/Etinilestradiol Mithra 0,120 mg/0,015 mg tijekom 24 sata, sustav za isporuku u rodnicu |
|---|---|
| Marketing Authorisation Number | HR-H-451616644 |
| Active Substance | etonogestrel etinilestradiol |
| Composition | 1 vaginalni prsten sadrži 11,7 mg etonogestrela i 2,7 mg etinilestradiola, tijekom razdoblja od 3 tjedna prsten 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 | Novalon S.A., Rue Saint-Georges 5, Liege, Belgija |
| Marketing Authorisation Date | 09.05.2023 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 20.01.2026* |
| Classification Number | UP/I-530-09/22-02/151 |
| Registration Number | 381-12-01/154-23-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | G02BB01 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
The marketing authorisation has been revoked pursuant to Article 58(1)(15) of the Medicinal Products Act, as the marketing authorisation holder no longer meets the conditions and obligations laid down in the Medicinal Products Act and the regulations adopted on the Medicinal Products Act.
