Sildenafil Pliva 20 mg filmom obložene tablete
| Name | Sildenafil Pliva 20 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-575973033 |
| 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] | 30 tableta u blisteru, u kutiji [HR-H-575973033-01] 90 tableta u blisteru, u kutiji [HR-H-575973033-02] 300 tableta u blisteru, u kutiji [HR-H-575973033-03] 90 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-575973033-04] |
| Manufacturer | Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka Teva Pharma B.V., Haarlem, Nizozemska Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 27.01.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/124 |
| Registration Number | 381-12-01/30-21-03 |
| 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 |
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. |
