Medicinal Products

Visine Classic 0,5 mg/ml kapi za oko, otopina

Name Visine Classic 0,5 mg/ml kapi za oko, otopina
Marketing Authorisation Number HR-H-564603810
Active Substance tetrizolinklorid
Composition 1 ml kapi za oko, otopine sadrži 0,5 mg tetrizolinklorida
Pharmaceutical Form kapi za oko, otopina
Manufacturer Janssen Pharmaceutica N.V., Beerse, Belgija
Marketing Authorisation Holder McNeil Healthcare (Ireland) Limited, Tallaght, High Street, Office 5, 6 & 7, Block 5, Dublin, Irska
Marketing Authorisation Date 19.01.2024
MA Period of Validity unlimited
MA Revocation Date 29.05.2025*
Classification Number UP/I-530-09/17-02/820
Registration Number 381-12-01/70-24-08
Prescription Medicinal product not subject to medical prescription
Distribution Supply through pharmacies (community) and non-pharmacy outlets
Advertising to general public allowed
ATC Code S01GA02
Marketing status trajni prekid opskrbe
SmPC download
PL 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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