Medicinal Products

Sunitinib Alpha-Medical 12,5 mg tvrde kapsule

Name Sunitinib Alpha-Medical 12,5 mg tvrde kapsule
Marketing Authorisation Number HR-H-292527691
Active Substance sunitinibmalat
Composition Jedna kapsula sadrži 12,5 mg sunitiniba u obliku sunitinibmalata
Pharmaceutical Form Kapsula, tvrda
Packaging [MA Number for Packaging] 28 kapsula u blisteru, u kutiji  [HR-H-292527691-01]
30 kapsula u blisteru, u kutiji  [HR-H-292527691-02]
28 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-292527691-03]
30 kapsula u blisteru s jediničnom dozom, u kutiji  [HR-H-292527691-04]
30 kapsula u bočici, u kutiji  [HR-H-292527691-05]
Manufacturer Synthon BV, Nijmegen, Nizozemska
Synthon Hispania S.L., Barcelona, Španjolska
Synthon s.r.o., Blansko, Češka
Marketing Authorisation Holder Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska
Marketing Authorisation Date 17.06.2021
MA Period of Validity 17.06.2026
MA Revocation Date 22.07.2022*
Classification Number UP/I-530-09/19-01/279
Registration Number 381-12-01/154-21-04
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01EX01
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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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