Details

Product Name in the RMS: Gliclada 90 mg Tabletten mit veränderter Wirkstofffreisetzung

MR Number: DE/H/0892/003
Date of outcome: 16.12.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Additional Strength/Form Other Chemical Substance Prescription Only
Active Substances	gliclazide 90 mg
Form	Modified release tablet
MA Holder in the RMS	KRKA d.d. NOVO mesto Smarjeska cesta 6 SLO-8501 NOVO MESTO Slovenia
RMS	Germany
Date of last change	12.02.2021
ATC-Code	A10BB09 Gliclazide

CMS Country	Domestic Product Name
Austria	Gliclada 90 mg Tabletten mit veränderter Wirkstofffreisetzung
Bulgaria	Gliclada
Croatia	Gliclada 90 mg tablete s prilagođenim oslobađanjem
Latvia	Gliclada 90 mg ilgstošās darbības tabletes
Lithuania	Gliclada 90 mg modifikuoto atpalaidavimo tabletės
Poland	Gliclada
Portugal
Romania
Slovak Republic	Gliclada 90 mg
Slovenia	Gliclada 90 mg tablete s prirejenim sproščanjem

Documents
PAR:	DE_H_0892_003_PAR.pdf (12.09.2019)
FinalSPC:	DE_H_0892_003_FinalSPC.zip (17.12.2015)
Finalised Product Information:	DE_H_0892_003_FinalPI.pdf (12.02.2021)