Medicinal Products

Voluven 6% otopina za infuziju

Name Voluven 6% otopina za infuziju
Marketing Authorisation Number HR-H-651961342
Active Substance hidroksietilškrob (130/0.4)
natrijev klorid
Composition 1000 ml otopine sadržavi 60 g hidroksietil-škroba (130/0,4) i 9 g natrij klorida
Pharmaceutical Form otopina za infuziju
Packaging [MA Number for Packaging] 20 vreća s 500 ml otopine, u kutiji  [HR-H-651961342-02]
1 plastična boca s 250 ml otopine, u kutiji  [HR-H-651961342-03]
10 plastičnih boca s 250 ml otopine, u kutiji  [HR-H-651961342-04]
20 plastičnih boca s 250 ml otopine, u kutiji  [HR-H-651961342-05]
30 plastičnih boca s 250 ml otopine, u kutiji  [HR-H-651961342-06]
1 plastična boca s 500 ml otopine, u kutiji  [HR-H-651961342-07]
10 plastičnih boca s 500 ml otopine, u kutiji  [HR-H-651961342-08]
20 plastičnih boca s 500 ml otopine, u kutiji  [HR-H-651961342-09]
Manufacturer Fresenius Kabi Deutschland GmbH, Bad Homburg, Njemačka
Fresenius Kabi France, Louviers, Francuska
Fresenius Kabi Polska Sp. z o.o., Kutno, Poljska
Marketing Authorisation Holder Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska
Marketing Authorisation Date 19.05.2017
MA Period of Validity unlimited
MA Revocation Date 17.07.2023*
Classification Number UP/I-530-09/15-02/295
Registration Number 381-12-01/70-17-06
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code B05AA07
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Educational materials
for healthcare professionals
Edukacija za zdravstvene radnike, 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o daljnjim mjerama za jačanje postojećih ograničenja primjene otopina za infuziju koje sadrže hidroksietil škrob 12.04.2019 Fresenius Kabi
Pismo zdravstvenim radnicima o novim mjerama za jačanje postojećih restrikcija u primjeni otopina za infuziju koje sadrže hidroksietil škrob (HES) 28.08.2018 B. Braun Adria d.o.o. i Fresenius Kabi d.o.o.
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