jedna bočica s 250 ml otopine za infuziju sadrži 400 mg moksifloksacina (u obliku moksifloksacinklorida) 1 ml otopine sadrži 1,6 mg moksifloksacina (u obliku moksifloksacinklorida)
Pharmaceutical Form
otopina za infuziju
Manufacturer
Pharmathen S.A., Pallini Attiki, Grčka
Marketing Authorisation Holder
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka
Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
Packaging
Packaging description
MA Number for Packaging
Marketing status
Shortage status
1 bočica s 250 ml otopine, u kutiji
HR-H-663339677-01
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-
5 bočica s 250 ml otopine, u kutiji
HR-H-663339677-02
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-
12 bočica s 250 ml otopine, u kutiji
HR-H-663339677-03
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-
Direct Healthcare Professional Communication
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Date
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