Details

Product Name in the RMS: Tritace Combi 10 mg/5 mg

MR Number: CZ/H/0674/003
Date of outcome: 14.05.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Additional Strength/Form Fixed Combination Chemical Substance Prescription Only
Active Substances	amlodipine besilate 5 mg ramipril 10 mg
Form	Capsule, hard
MA Holder in the RMS	Zentiva, k.s., U kabelovny 130 102 37 Praha 10 - Dolní Měcholupy The Czech Republic FORMER RMS: SE/1339
RMS	Czech Republic
Date of last change	21.10.2018
ATC-Code	C09BB07 ramipril and amlodipine

CMS Country	Domestic Product Name
Bulgaria
Cyprus	Amlodipine + Ramipril Adamed HARD CAPS
Greece	AMLODIPINE+RAMIPRIL/ADAMED
Italy
Poland	Amrap
Slovak Republic	Ramipril/Amlodipin Zentiva 10 mg/5 mg

Documents
PAR:	http://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20130306000085 (16.01.2015)
PARSummary:	http://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20130306000085 (16.01.2015)
FinalSPC:	http://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20130306000085 (04.09.2014)
FinalPL:	http://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20130306000085 (04.09.2014)
Finalised Product Information:	CZ_H_0674_003_FinalPI.pdf (09.07.2018)