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	03.03.2020
ATC-Code	N05AH04 Quetiapine

CMS Country	Domestic Product Name
Austria
Finland
Germany	Quetiapin Pharmathen 150 mg Retardtabletten
Greece	QUETIAPINE/HEXAL
Iceland
Italy
Luxembourg
Netherlands
Poland	Kvelux SR
Portugal
Romania	Netiapin 150 mg comprimate cu eliberare prelungită
Slovenia
Sweden
United Kingdom

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.pdf (31.08.2018)
FinalPL:	DK_H_2334_002_FinalPL.pdf (31.08.2018)
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)