Details

Product Name in the RMS: Gliclazida Lupin

MR Number: PT/H/1272/001
Date of outcome: 01.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	gliclazide 60 mg
Form	Modified release tablet
MA Holder in the RMS	Lupin (Europe) Ltd
RMS	Portugal
Date of last change	12.02.2019
ATC-Code	A10BB09 Gliclazide

CMS Country	Domestic Product Name
Bulgaria	Gliclazide Lupin
Lithuania	Gliklazidas Lupin 60 mg pailginto atpalaidavimo tabletės
Poland
Romania	Gliclazida Lupin 60 mg comprimate cu eliberare prelungita

Documents
Finalised Product Information:	PT_H_1272_001_FinalPI_1of4.pdf (01.07.2015)
Finalised Product Information:	PT_H_1272_001_FinalPI_2of4.pdf (01.07.2015)
Finalised Product Information:	PT_H_1272_001_FinalPI_3of4.pdf (01.07.2015)
Finalised Product Information:	PT_H_1272_001_FinalPI_4of4.pdf (01.07.2015)