Details
Product Name in the RMS: Gliclazide Actavis
MR Number: DK/H/2376/001
Date of outcome: 24.03.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
gliclazide 30 mg |
Form | Modified release tablet |
MA Holder in the RMS |
Splitting procedure: New split procedure number is UK/H/6899/001 (IE, UK) Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður, Iceland |
RMS | Denmark |
Date of last change | 28.09.2018 |
ATC-Code |
A10BB09 Gliclazide |
CMS Country | Domestic Product Name |
---|---|
Cyprus | AZILDOR 30MG |
Czech Republic | GLIKLAZID ACTAVIS 30 MG |
Estonia | GLICLAZIDE ACTAVIS |
Greece | GLICLAZIDE/ACTAVIS |
Ireland | |
Lithuania | |
Malta | Azildor |
Romania | |
United Kingdom |
Documents | |
---|---|
PAR: | DK_H_2376_001_PAR.pdf (22.08.2016) |
PARSummary: | DK_H_2376_001_PARSummary.pdf (22.08.2016) |
FinalSPC: | http://mri.medagencies.org/download/DK_H_2376_001_FinalSPC.pdf (24.03.2015) |
Finalised Product Information: | DK_H_2376_001_FinalPI.pdf (29.08.2018) |