Sildenafil Alpha-Medical 20 mg filmom obložene tablete
| Name | Sildenafil Alpha-Medical 20 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-193404304 |
| Active Substance | sildenafilcitrat |
| Composition | jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata) |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 90 tableta u bočici, u kutiji [HR-H-193404304-01] 90 tableta u blisteru, u kutiji [HR-H-193404304-02] |
| Manufacturer | Synoptis Industrial Sp. z o.o., Swarzedz, Poljska Macleods Pharma UK Limited, Wynyard, Billingham, Ujedinjeno Kraljevstvo |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 12.12.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/150 |
| Registration Number | 381-12-01/154-22-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G04BE03 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download download |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o prijevremeno prekinutom kliničkom ispitivanju primjene sildenafila za liječenje intrauterinog zastoja rasta | 16.10.2018 | Alpha-Medical d.o.o., Belupo lijekovi i kozmetika d.d., Krka – farma d.o.o., Pfizer Croatia d.o.o., PharmaS d.o.o., Pliva Hrvatska d.o.o. i Sandoz d.o.o. |
