Product Name in the RMS: Roxiper 4 mg/1.25 mg/20 mg filmtabletta

MR Number: HU/H/0484/002
Date of outcome: 25.07.2018

Type of application
Level 1:
Level 2:
Level 3:
Level 4:
Level 5:
Known Active Substance
Initial Application
Fixed Combination
Chemical Substance
Prescription Only
Active Substances indapamide 1,25 mg
perindopril 4 mg
rosuvastatin 20 mg
Form Film coated tablet
MA Holder in the RMS KRKA, d.d., Novo mesto
?marje?ka cesta 6
Novo mesto
8501
Slovenia
Telephone +38673319037
Telefax +38673322742
RMS Hungary
Date of last change 22.02.2021
ATC-Code C10BX HMG CoA reductase inhibitors, other combinations
CMS Country Domestic Product Name
Bulgaria Roxiper
Estonia ROXIPER
Finland
Latvia Triemma 20 mg/4 mg/1,25 mg apvalkotās tabletes
Lithuania Roxiper 20 mg/4 mg/1,25 mg pl?vele dengtos tablet?s
Poland
Portugal
Romania
Slovak Republic Roxiper 20 mg/4 mg/1,25 mg filmom obalené tablety
Slovenia Roxiper 20 mg/4 mg/1,25 mg filmsko oblo?ene tablete
Documents
PAR: HU_H_0484_002_PAR.pdf (22.05.2020)