Details

Product Name in the RMS: Diclopram

MR Number: EE/H/0266/001
Date of outcome: 08.09.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Fixed Combination Chemical Substance Prescription Only
Active Substances	diclofenac sodium 75 mg omeprazole 20 mg
Form	Modified-release capsule, hard
MA Holder in the RMS	Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24 Ireland
RMS	Estonia
Date of last change	25.09.2020
ATC-Code	M01AB55 Diclofenac, combinations

CMS Country	Domestic Product Name
Bulgaria
Cyprus	DICLODUO COMBI MR HARD CAPS
Greece	DICLODUO COMBI
Hungary	DIOM 75 mg/20 mg módosított hatóanyagleadású kemény kapszula
Latvia
Lithuania	DIOMPRAZ 75 mg/20 mg modifikuoto atpalaidavimo kietosios kapsulės
Malta	DICLODUO COMBI 75 mg / 20 mg, modified release hard
Poland
Romania	DICLOPRAM 75 mg/20 mg capsule cu eliberare modificată
Slovak Republic	DIOMPRAZ 75 mg/20 mg tvrdé kapsuly s riadeným uvoľňovaním

Documents
FinalSPC:	EE_H_0266_001_FinalSPC.pdf (09.10.2019)
FinalPL:	EE_H_0266_001_FinalPL.pdf (09.10.2019)