Gapulsid 1 mg tablete
| Name | Gapulsid 1 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-759403271 |
| Active Substance | cinitapridhidrogentartarat |
| Composition | svaka tableta sadrži 1 mg cinitaprida (u obliku cinitapridhidrogentartarata) |
| Pharmaceutical Form | Tableta |
| Manufacturer | SAG Manufacturing S.L.U., San Agustin del Guadalix, Madrid, Španjolska Galenicum Health S.L., Esplugues de Llobregat, Barcelona, Španjolska |
| Marketing Authorisation Holder | Novatin Limited, 5a Bokka Tac-Carcara, Limiti Ta'L-Mgarr, Malta |
| Marketing Authorisation Date | 07.06.2023 |
| MA Period of Validity | 07.06.2028 |
| Classification Number | UP/I-530-09/22-01/85 |
| Registration Number | 381-12-01/154-23-10 |
| 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 | A03FA08 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
