Tornetis 100 mg tablete
| Name | Tornetis 100 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-059459296 |
| Active Substance | sildenafilcitrat |
| Composition | jedna tableta sadrži 100 mg sildenafila (u obliku citrata) |
| Pharmaceutical Form | tableta |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija Lek Pharmaceuticals d.d., Lendava, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb |
| Marketing Authorisation Date | 22.03.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/70 |
| Registration Number | 381-12-01/38-18-06 |
| 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 | G04BE03 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
Packaging
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. |