Medicinal Products

Tiramat 25 mg filmom obložene tablete

Name Tiramat 25 mg filmom obložene tablete
Marketing Authorisation Number HR-H-258427363
Active Substance topiramat
Composition jedna filmom obložena tableta sadrži 25 mg topiramata
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 60 tableta u blisteru, u kutiji  [HR-H-258427363-01]
Manufacturer Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska
Marketing Authorisation Holder Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica
Marketing Authorisation Date 05.02.2018
MA Period of Validity unlimited
MA Revocation Date 18.05.2024*
Classification Number UP/I-530-09/17-02/117
Registration Number 381-12-01/30-18-05
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N03AX11
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Educational materials
for healthcare professionals
Vodič za zdravstvene radnike, verzija 1
Educational materials
for patients / caregivers
Vodič za bolesnicu, verzija 1

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o novim ograničenjima za sprječavanje izlaganja tijekom trudnoće lijekovima koji sadrže topiramat 02.11.2023 Belupo lijekovi i kozmetika d.d., Johnson & Johnson S.E. d.o.o.
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