Details

Product Name in the RMS: Olytabs 200 mg/30 mg Filmtabletten

MR Number: IE/H/1134/001
Date of outcome: 02.11.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Multiple (Copy) Application Generic Chemical Substance Non Prescription (including OTC)
Active Substances	ibuprofen 200 mg pseudoephedrine 30 mg
Form	Film coated tablet
MA Holder in the RMS	Johnson & Johnson GmbH Johnson & Johnson Platz 2 D-41470 Neuss Germany
RMS	Ireland
Date of last change	20.08.2020
ATC-Code	R05X OTHER COLD COMBINATION PREPARATIONS

CMS Country	Domestic Product Name
Belgium	Sinuphene 200mg/30mg filmomhulde tabletten
Bulgaria	Olytab Duo
Croatia	Olytabs 200 mg/30 mg filmom obložene tablete
Italy
Luxembourg
Malta
Portugal
Romania	Olytabs 200 mg/30 mg comprimate filmate
United Kingdom

Documents
PAR:	IE_H_1134_001_PAR.pdf (24.07.2017)
FinalPL:	IE_H_1134_001_FinalPL.pdf (04.07.2018)
FinalLabelling:	IE_H_1134_001_FinalLabelling.pdf (04.07.2018)
Finalised Product Information:	IE_H_1134_001_FinalPI_1of2.pdf (09.01.2020)
Finalised Product Information:	IE_H_1134_001_FinalPI_2of2.pdf (09.01.2020)