Details

Product Name in the RMS: Intestat

MR Number: DK/H/2444/001
Date of outcome: 18.11.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	ezetimibe 10 mg
Form	Tablet
MA Holder in the RMS	Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary
RMS	Denmark
Date of last change	24.03.2018
ATC-Code	C10AX09 Ezetimib

CMS Country	Domestic Product Name
Czech Republic	Coltowan 10 mg tablety
Hungary
Latvia	Coltowan 10 mg tabletes
Poland
Slovak Republic	Coltowan 10 mg tablety

Documents
PAR:	DK_H_2444_001_PAR.pdf (05.01.2016)
PARSummary:	DK_H_2444_001_PARSummary.pdf (05.01.2016)
FinalSPC:	DK_H_2444_001_FinalSPC.pdf (22.02.2018)
FinalPL:	DK_H_2444_001_FinalPL.pdf (10.01.2018)
FinalLabelling:	DK_H_2444_001_FinalLabelling.pdf (10.01.2018)