Medicinal Products

Dobutamin Panpharma 250 mg/20 ml koncentrat za otopinu za infuziju

Name Dobutamin Panpharma 250 mg/20 ml koncentrat za otopinu za infuziju
Marketing Authorisation Number HR-H-694824050
Active Substance dobutaminklorid
Composition 1 bočica sa 20 ml sadrži 250 mg dobutamina u obliku 280,2 mg dobutaminklorida
Pharmaceutical Form koncentrat za otopinu za infuziju
Manufacturer Panpharma GmbH, Trittau, Njemačka
Marketing Authorisation Holder Panpharma, Z.I. du Clairay, Luitre, Francuska
Marketing Authorisation Date 31.07.2017
MA Period of Validity unlimited
MA Revocation Date 16.07.2025*
Classification Number UP/I-530-09/15-02/166
Registration Number 381-12-01/70-17-07
Prescription Medicinal product subject to medical prescription
Type of prescription ograničeni recept
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code C01CA07
Marketing status stavljeno u promet
Shortage status u tijeku
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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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