Details

Product Name in the RMS: Ibusan 200mg soft capsules

MR Number: HU/H/0451/001
Date of outcome: 28.08.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Non Prescription (including OTC)
Active Substances	ibuprofen 200 mg
Form	Capsule, soft
MA Holder in the RMS	SANOFI-AVENTIS, Zrt. Tó u.1-5 Budapest 1045 Hungary
RMS	Hungary
Date of last change	02.06.2020
ATC-Code	M01AE01 Ibuprofen

CMS Country	Domestic Product Name
Czech Republic	IBALGIN LIQUIDCAPS 200mg
Italy
Romania	ANTINEVRALGIC EXPRESS 200 mg capsule gelatinoase moi
Slovak Republic	IBALGIN RAPIDCAPS 200 mg

Documents
FinalSPC:	http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1412571823068.pdf (02.12.2014)
FinalPL:	http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1412571822860.pdf (02.12.2014)
FinalLabelling:	HU_H_0451_001_FinalLabelling.pdf (02.12.2014)