Details

Product Name in the RMS: Rivendra

MR Number: DK/H/2363/002
Date of outcome: 08.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Non Prescription (including OTC)
Active Substances	ambroxol hydrochloride 60 mg
Form	Effervescent tablet
MA Holder in the RMS	splitting procedure: Old/New splitted procedure number is HU/H/0573/001 (HU, PL) Actavis Group PTC ehf. Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
RMS	Denmark
Date of last change	15.08.2019
ATC-Code	R05CB06 Ambroxol

CMS Country	Domestic Product Name
no CMS entries available for this product

Documents
PAR:	DK_H_2363_002_PAR.pdf (13.08.2015)
PARSummary:	DK_H_2363_002_PARSummary.pdf (13.08.2015)
FinalSPC:	DK_H_2363_002_FinalSPC.pdf (22.02.2019)
FinalPL:	DK_H_2363_002_FinalPL.pdf (22.02.2019)
FinalLabelling:	DK_H_2363_002_FinalLabelling.pdf (22.02.2019)
Finalised Product Information:	DK_H_2363_002_FinalPI.pdf (03.10.2016)