Details

Product Name in the RMS: Atosiban 37.5 mg/5 ml concentrate for solution for infusion

MR Number: NL/H/4551/001
Date of outcome: 22.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	atosiban acetate 37,5 mg/ml
Form	Concentrate for solution for infusion
MA Holder in the RMS	Accord Healthcare Limited. Sage House, 319 Pinner road, North Harrow, Middlesex, HA1 4HF UK
RMS	Netherlands
Date of last change	08.06.2020
ATC-Code	G02CX01 Atosiban

CMS Country	Domestic Product Name
Austria	Atosiban Accord 37,5 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
Czech Republic	Atosiban Accord 37.5 mg/5 ml koncentrát pro infuzní roztok
Denmark
Finland
France
Germany	Atosiban Accord 37,5 mg/5ml
Ireland
Italy
Lithuania	Atosiban Accord 37,5 mg/5 ml koncentratas infuziniam tirpalui
Malta	Atosiban Concentrate for Soln for Inf 37.5mg/5ml
Norway	Atosiban Accord
Poland	Atosiban Accord
Portugal
Spain
Sweden	Atosiban Accord
United Kingdom	Atosiban 37.5 mg/5 ml concentrate for solution for infusion

Documents
FinalPL:	NL_H_4551_001_FinalPL_1of2.pdf (17.01.2020)
FinalPL:	NL_H_4551_001_FinalPL_2of2.pdf (17.01.2020)