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 | |
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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) |