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	14.02.2018
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
Czech Republic	GLYCLADA 90 MG
Estonia	GLICLADA
Latvia	Gliclada 90 mg ilgstošās darbības tabletes
Lithuania	Gliclada 90 mg modifikuoto atpalaidavimo tabletės
Poland
Portugal
Romania
Slovak Republic	Gliclada 90 mg
Slovenia	Gliclada 90 mg tablete s prirejenim sproščanjem

Documents
FinalSPC:	DE_H_0892_003_FinalSPC.zip (17.12.2015)
Finalised Product Information:	DE_H_0892_003_FinalPI.pdf (19.07.2017)