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 |