Details

Product Name in the RMS: ASPIRIN COMPLEX HEISSGETRÄNK 500 mg / 30 mg Granulat zur Herstellung

MR Number: DE/H/3635/001
Date of outcome: 11.09.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Line Extension Initial Application Fixed Combination Chemical Substance Non Prescription (including OTC)
Active Substances	acetylsalicylic acid 500 mg pseudoephedrine hydrochloride 30 mg
Form	Granules for oral suspension
MA Holder in the RMS	Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 D-51373 Leverkusen Germany
RMS	Germany
Date of last change	13.08.2020
ATC-Code	N02BA01 Acetylsalicylic acid R01BA02 Pseudoephedrine

CMS Country	Domestic Product Name
Austria
Bulgaria	Aspirin Complex Hotdrink
Hungary	ASPIRIN COMPLEX Forró Ital 500 mg/30 mg granulátum belsőleges szuszpenzióhoz
Poland	Aspirin Complex Hot
Romania	ASPIRIN COMPLEX HOT DRINK 500 mg/30 mg granule
Slovak Republic	ASPIRIN COMPLEX Horúci nápoj

Documents
PAR:	DE_H_3635_001_PAR.pdf (26.02.2014)
FinalSPC:	DE_H_3635_001_FinalSPC.pdf (11.09.2013)
FinalPL:	DE_H_3635_001_FinalPL.pdf (11.09.2013)
FinalLabelling:	DE_H_3635_001_FinalLabelling.pdf (11.09.2013)
Finalised Product Information:	DE_H_3635_001_FinalPI_1of4.pdf (18.09.2017)
Finalised Product Information:	DE_H_3635_001_FinalPI_2of4.pdf (18.09.2017)
Finalised Product Information:	DE_H_3635_001_FinalPI_3of4.pdf (18.09.2017)
Finalised Product Information:	DE_H_3635_001_FinalPI_4of4.pdf (18.09.2017)