Arupsan 800 mg tablete
| Name | Arupsan 800 mg tablete |
|---|---|
| Former Name | Eslikarbazepinacetat Accord 800 mg tablete |
| Marketing Authorisation Number | HR-H-675977134 |
| Active Substance | eslikarbazepinacetat |
| Composition | jedna tableta sadrži 800 mg eslikarbazepinacetata |
| Pharmaceutical Form | tableta |
| Manufacturer | Laboratori Fundacio Dau, Barcelona, Španjolska Pharmadox Healthcare Limited, Paola, Malta Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 15.01.2021 |
| MA Period of Validity | 15.01.2026 |
| Classification Number | UP/I-530-09/19-01/175 |
| Registration Number | 381-12-01/70-21-02 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N03AF04 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
