Details

Product Name in the RMS: Paracetamol-Actavis 10 mg/ml Infusionslösung

MR Number: DE/H/2210/001
Date of outcome: 03.02.2010

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	paracetamol 10 mg/ml
Form	Solution for infusion
MA Holder in the RMS	Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur
RMS	Germany
Date of last change	24.01.2013
ATC-Code	N02BE01 Paracetamol

CMS Country	Domestic Product Name
Austria	Paracetamol Actavis 10 mg/ml Infusionslösung
Belgium
Bulgaria	Paracetamol Neogen
Czech Republic	Paracetamol Neogen 10 mg/ml infuzní roztok
Denmark
Finland
Hungary	Paracetamol Neogen
Ireland
Italy
Luxembourg
Netherlands
Norway
Poland	Paracetamol Neogen
Portugal
Romania	Paracetamol Actavis 10mg/ml soluţie perfuzabilǎ
Spain
Sweden

Documents
PAR:	http://www.hma.eu/fileadmin/dateien/pipar/de2210/parmod5_de221001paracetamolneogen.pdf (01.12.2011)
FinalSPC:	http://www.hma.eu/fileadmin/dateien/pipar/de2210/spc_de221001paracetamolneogen.pdf (01.12.2011)
FinalPL:	http://www.hma.eu/fileadmin/dateien/pipar/de2210/pllab_de221001paracetamolneogen.pdf (01.12.2011)
FinalLabelling:	http://www.hma.eu/fileadmin/dateien/pipar/de2210/pllab_de221001paracetamolneogen.pdf (01.12.2011)