Details

Product Name in the RMS: Quetiapin "Hexal"

MR Number: DK/H/2334/002
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 150 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
Finland
Germany	Quetiapin Pharmathen 150 mg Retardtabletten
Iceland
Italy
Luxembourg
Netherlands
Poland	Kvelux SR
Portugal
Romania	Netiapin 150 mg comprimate cu eliberare prelungită
Slovenia
Sweden
XI

Documents
PAR:	DK_H_2334_002_PAR_1of2.pdf (25.01.2018)
PAR:	DK_H_2334_002_PAR_2of2.pdf (25.01.2018)
PARSummary:	DK_H_2334_002_PARSummary.pdf (26.01.2016)
FinalSPC:	DK_H_2334_002_FinalSPC_1of2.pdf (29.11.2021)
FinalSPC:	DK_H_2334_002_FinalSPC_2of2.pdf (29.11.2021)
FinalPL:	DK_H_2334_002_FinalPL_1of2.pdf (29.11.2021)
FinalPL:	DK_H_2334_002_FinalPL_2of2.pdf (29.11.2021)
FinalLabelling:	DK_H_2334_002_FinalLabelling.pdf (02.03.2015)
Finalised Product Information:	DK_H_2334_002_FinalPI_1of2.pdf (20.12.2018)
Finalised Product Information:	DK_H_2334_002_FinalPI_2of2.pdf (20.12.2018)