Utrogestan 200 mg meke kapsule za rodnicu
| Name | Utrogestan 200 mg meke kapsule za rodnicu |
|---|---|
| Marketing Authorisation Number | HR-H-957395225 |
| Active Substance | progesteron |
| Composition | jedna kapsula sadrži 200 mg progesterona (mikroniziranog) |
| Pharmaceutical Form | kapsula za rodnicu, meka |
| Manufacturer | Cyndea Pharma S.L., Olvega, Soria, Španjolska Besins Manufacturing España S.L., Muel, Zaragoza, Španjolska |
| Marketing Authorisation Holder | Besins Healthcare Ireland Limited, Plaza 4, Level 4 Custom House Plaza, Harbourmaster Place, International Financial Services Centre, Dublin 1, Irska |
| Marketing Authorisation Date | 06.12.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/116 |
| Registration Number | 381-12-01/14-23-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | G03DA04 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
