Details

Product Name in the RMS: Quetiapin "Hexal"

MR Number: DK/H/2334/005
Date of outcome: 11.11.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	quetiapine 400 mg
Form	Prolonged release tablet
MA Holder in the RMS	Hexal A/S Edvard Thomsens Vej 14 2300 København S Denmark
RMS	Denmark
Date of last change	29.11.2021
ATC-Code	N05AH04 Quetiapine

CMS Country	Domestic Product Name
Austria
Belgium	Quetiapin Retard Sandoz 400 mg
Finland
France
Germany	Quetiapin Pharmathen 400 mg Retardtabletten
Iceland
Ireland
Italy
Luxembourg
Netherlands
Poland	Kvelux SR
Portugal
Romania	Netiapin 400 mg comprimate cu eliberare prelungită
Slovenia
Sweden
XI

Documents
PAR:	DK_H_2334_005_PAR_1of2.pdf (25.01.2018)
PAR:	DK_H_2334_005_PAR_2of2.pdf (25.01.2018)
PARSummary:	DK_H_2334_005_PARSummary.pdf (26.01.2016)
FinalSPC:	DK_H_2334_005_FinalSPC_1of2.pdf (29.11.2021)
FinalSPC:	DK_H_2334_005_FinalSPC_2of2.pdf (29.11.2021)
FinalPL:	DK_H_2334_005_FinalPL_1of2.pdf (29.11.2021)
FinalPL:	DK_H_2334_005_FinalPL_2of2.pdf (29.11.2021)
FinalLabelling:	DK_H_2334_005_FinalLabelling.pdf (23.03.2016)
Finalised Product Information:	DK_H_2334_005_FinalPI_1of2.pdf (20.12.2018)
Finalised Product Information:	DK_H_2334_005_FinalPI_2of2.pdf (20.12.2018)