Medicinal Products

Efavirenz Alpha-Medical 600 mg filmom obložene tablete

Name Efavirenz Alpha-Medical 600 mg filmom obložene tablete
Marketing Authorisation Number HR-H-180844321
Active Substance efavirenz
Composition jedna filmom obložena tableta sadrži 600 mg efavirenza
Pharmaceutical Form filmom obložena tableta
Packaging [MA Number for Packaging] 30 tableta u bočici, u kutiji  [HR-H-180844321-01]
30 tableta u blisteru, u kutiji  [HR-H-180844321-02]
90 tableta u blisteru, u kutiji  [HR-H-180844321-03]
30 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-180844321-04]
90 tableta u blisteru s jediničnom dozom, u kutiji  [HR-H-180844321-05]
Manufacturer Pharmadox Healthcare Limited, Paola PLA, Malta
Accord Healthcare B.V., Utrecht, Nizozemska
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 07.04.2021
MA Period of Validity unlimited
MA Revocation Date 13.03.2023*
Classification Number UP/I-530-09/19-02/44
Registration Number 381-12-01/70-21-07
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J05AG03
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download

*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

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