Details

Product Name in the RMS: Mirzasna 15 mg

MR Number: NL/H/1087/001
Date of outcome: 21.11.2007

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	mirtazapine 15 mg
Form	Orodispersible tablet
MA Holder in the RMS	Krka d.d. Novo MEsto Šmarješka cesta 6 8501 Novo mesto Slovenia
RMS	Netherlands
Date of last change	14.09.2012
ATC-Code	N06AX11 Mirtazapine

CMS Country	Domestic Product Name
Bulgaria	Mirzaten Q TAB
Czech Republic	Mirzaten Oro Tab 15 mg orodispersible tablets
Denmark	41901
Estonia
Germany	Mirzaten 15 mg Schmelztabletten
Norway
Poland	Mirzaten Q-Tab 15 mg tabletki ulegające rozpadowi w jamie ustnej
Romania	Mirzaten Q-Tab 15 mg comprimate orodispersabile
Slovak Republic
Sweden	Mirtin
United Kingdom

Documents
PAR:	http://db.cbg-meb.nl/mri/par/nlh-1087-001-002-003.pdf (26.04.2010)
Finalised Product Information:	http://mri.medagencies.org/download/NL_H_1087_001_FinalPI.pdf (17.08.2012)