Medicinal Products

Duphalac 667 mg/ml sirup

Name Duphalac 667 mg/ml sirup
Marketing Authorisation Number HR-H-833932438
Active Substance laktuloza, tekuća
Composition 1 ml sirupa sadrži 667 mg laktuloze u obliku laktuloze, tekuće
Pharmaceutical Form sirup
Manufacturer Abbott Biologicals B.V., Olst, Nizozemska
Marketing Authorisation Holder Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska
Marketing Authorisation Date 11.10.2019
MA Period of Validity unlimited
MA Revocation Date 07.07.2025*
Classification Number UP/I-530-09/17-02/681
Registration Number 381-12-01/38-19-03
Prescription Medicinal product subject to medical prescription
Type of prescription neponovljivi recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code A06AD11
Marketing status trajni prekid opskrbe
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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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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