Details

Product Name in the RMS: Ibandronic acid Synthon Hispania 6 mg

MR Number: NL/H/2126/002
Date of outcome: 23.12.2011

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Multiple (Copy) Application Generic Chemical Substance Prescription Only
Active Substances	ibandronic acid 6 mg
Form	Concentrate for solution for infusion
MA Holder in the RMS	Synthon Hispania, S.L. Castello 1 08830 Sant Boi de Llobregat Spain
RMS	Netherlands
Date of last change	13.06.2012
ATC-Code	M05BA06 Ibandronic acid

CMS Country	Domestic Product Name
Austria	Ibandronsäure STADA 6 mg Konzentrat zur Herstellung einer Infusionslösung
Belgium
Germany	Ibandronsäure Synthon Hispania 6 mg Konzentrat zur Herstellung einer Infusionslösung
Luxembourg
Slovenia

Documents
PAR:	http://mri.medagencies.org/download/NL_H_2126_002_PAR.pdf (23.12.2011)
FinalSPC:	http://mri.medagencies.org/download/NL_H_2126_002_FinalSPC_1of2.pdf (22.02.2012)
FinalSPC:	http://mri.medagencies.org/download/NL_H_2126_002_FinalSPC_2of2.pdf (22.02.2012)
FinalPL:	http://mri.medagencies.org/download/NL_H_2126_002_FinalPL_1of2.pdf (23.12.2011)
FinalPL:	http://mri.medagencies.org/download/NL_H_2126_002_FinalPL_2of2.pdf (23.12.2011)
FinalLabelling:	http://mri.medagencies.org/download/NL_H_2126_002_FinalLabelling_1of2.pdf (23.12.2011)
FinalLabelling:	http://mri.medagencies.org/download/NL_H_2126_002_FinalLabelling_2of2.pdf (23.12.2011)