Details
Product Name in the RMS: Rivendra
MR Number: DK/H/2363/002
Date of outcome: 08.07.2015
Type of application | |
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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 | 20.08.2020 |
ATC-Code |
R05CB06 Ambroxol |
CMS Country | Domestic Product Name |
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no CMS entries available for this product |
Documents | |
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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 (10.06.2020) |
FinalPL: | DK_H_2363_002_FinalPL.pdf (10.06.2020) |
FinalLabelling: | DK_H_2363_002_FinalLabelling.pdf (10.06.2020) |
Finalised Product Information: | DK_H_2363_002_FinalPI.pdf (03.10.2016) |