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 |
| 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 | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | G02BB01 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
