Details

Product Name in the RMS: ROSUDAPIN 20 mg/10 mg film-coated tablet

MR Number: HU/H/0388/004
Date of outcome: 29.07.2015

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	amlodipine besilate 10 mg rosuvastatin calcium 20 mg
Form	Film-coated tablet
MA Holder in the RMS	Krka, d.d., Novo mesto (SI)
RMS	Hungary
Date of last change	03.03.2020
ATC-Code	C10BX HMG CoA reductase inhibitors, other combinations

CMS Country	Domestic Product Name
Bulgaria	Rosudapin
Lithuania	Rosvaden 20 mg/10 mg plėvele dengtos tabletės
Poland
Romania	ROSUDAPIN
Slovenia

Documents
PAR:	HU_H_0388_004_PAR.pdf (14.10.2015)