Details

Product Name in the RMS: Amaloris 5 mg/10 mg Film-coated Tablets

MR Number: SI/H/0142/003
Date of outcome: 09.04.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Line Extension Initial Application Generic Chemical Substance Prescription Only
Active Substances	amlodipine besilate 5 mg atorvastatin calcium trihydrate 10 mg
Form	Film coated tablet
MA Holder in the RMS	Krka, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto Slovenia
RMS	Slovenia
Date of last change	14.01.2019
ATC-Code	C10BX03 Atorvastatin and amlodipine

CMS Country	Domestic Product Name
Bulgaria	Atordapin
Czech Republic	Atordapin 5 mg / 10 mg
Estonia	AMALORIS
Latvia	Atordapin 5 mg+10 mg apvalkotās tabletes
Lithuania	Atordapin 5 mg/10 mg plėvele dengtos tabletės
Poland	Atordapin
Portugal
Romania	Atordapin 5 mg/10 mg comprimate filmate
Slovak Republic	Atordapin 5 mg/10 mg filmom obalené tablety
Spain

Documents
Finalised Product Information:	SI_H_0142_003_FinalPI.pdf (20.07.2018)