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	20.09.2019
ATC-Code	A10BB09 Gliclazide

CMS Country	Domestic Product Name
Czech Republic	GLIKLAZID ACTAVIS 30 MG
Estonia

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)