Medicinal Products

Loquen XR 50 mg tablete s produljenim oslobađanjem

Name Loquen XR 50 mg tablete s produljenim oslobađanjem
Marketing Authorisation Number HR-H-441303743
Active Substance quetiapinum
Composition svaka tableta sadrži 50 mg kvetiapina u obliku kvetiapinfumarata
Pharmaceutical Form tableta s produljenim oslobađanjem
Packaging [MA Number for Packaging] 10 tableta u blisteru, u kutiji  [HR-H-441303743-01]
20 tableta u blisteru, u kutiji  [HR-H-441303743-02]
30 tableta u blisteru, u kutiji  [HR-H-441303743-03]
50 tableta u blisteru, u kutiji  [HR-H-441303743-04]
50 tableta u u blisteru s jediničnom dozom, u kutiji  [HR-H-441303743-05]
56 tableta u blisteru, u kutiji  [HR-H-441303743-06]
60 tableta u blisteru, u kutiji  [HR-H-441303743-07]
90 tableta u blisteru, u kutiji  [HR-H-441303743-08]
100 tableta u blisteru, u kutiji  [HR-H-441303743-09]
60 tableta u bočici, u kutiji  [HR-H-441303743-10]
Manufacturer Teva Gyogyszergyar Zrt., Debrecen, Mađarska
Pharmachemie B.V., Haarlem, Nizozemska
Teva Czech Industries s.r.o., Opava-Komarov, Češka
Teva Operations Poland Sp. z o.o., Krakow, Poljska
Teva Pharma S.L.U., Zaragoza, Španjolska
Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, Njemačka
Adamed Sp. z o.o., Czosnow, Poljska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 08.05.2019
MA Period of Validity unlimited
MA Revocation Date 18.05.2021*
Classification Number UP/I-530-09/18-02/161
Registration Number 381-12-01/38-19-04
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code N05AH04
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Podsjetnik o važnosti nadziranja metaboličkih parametara tijekom liječenja kvetiapinom, verzija 2

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Marketing authorisation has been revoked by request of the marketing authorisation holder.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