Medicinal Products

Pamitor 15 mg/ml koncentrat za otopinu za infuziju

Name Pamitor 15 mg/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number HR-H-464606695
Active Substance dinatrijev pamidronat
Composition 1 ml koncentrata sadrži 15,0 mg dinatrijevog pamidronata, što odgovara 12,6 mg pamidronatne kiseline
Pharmaceutical Form koncentrat za otopinu za infuziju
Packaging [MA Number for Packaging] 1 ampula s 2 ml koncentrata, u kutiji  [HR-H-464606695-01]
1 ampula s 4 ml koncentrata, u kutiji  [HR-H-464606695-02]
1 ampula s 6 ml koncentrata, u kutiji  [HR-H-464606695-03]
Manufacturer Chiesi Pharmaceuticals GmbH, Beč, Austrija
Marketing Authorisation Holder Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, Beč, Austrija
Marketing Authorisation Date 27.09.2016
MA Period of Validity unlimited
MA Revocation Date 18.01.2022*
Classification Number UP/I-530-09/15-02/259
Registration Number 381-12-01/38-16-09
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code M05BA03
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for patients / caregivers
Kartica za bolesnika, verzija 1

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Marketing authorisation has been revoked by request of the marketing authorisation holder.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