Details

Product Name in the RMS: Omeplis 10mg

MR Number: NL/H/2939/001
Date of outcome: 03.06.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	omeprazole 10 mg
Form	Gastro-resistant capsule, hard
MA Holder in the RMS	Esteve Pharmaceuticals, S.A. Passeig de la Zona Franca, 109 08038 Barcelona Spain Splitting procedure: New splitted procedure number is IE/H/508/1-3/MR
RMS	Netherlands
Date of last change	13.01.2019
ATC-Code	A02BC01 Omeprazole

CMS Country	Domestic Product Name
Belgium
Czech Republic	Omecat 10 mg gastro-resistant capsule, hard
Germany	Omeboix 10 mg magensaftresistente Hartkapsel
Italy
Poland
Romania	Omeplis 10 mg capsule gastrorezistente
Spain

Documents
PAR:	NL_H_2939_001_PAR.pdf (12.02.2015)
PARSummary:	NL_H_2939_001_PARSummary.pdf (12.02.2015)
FinalSPC:	NL_H_2939_001_FinalSPC_1of2.pdf (04.04.2017)
FinalSPC:	NL_H_2939_001_FinalSPC_2of2.pdf (04.04.2017)
FinalPL:	NL_H_2939_001_FinalPL.pdf (07.08.2018)
FinalLabelling:	NL_H_2939_001_FinalLabelling.pdf (03.06.2014)
Finalised Product Information:	NL_H_2939_001_FinalPI_1of6.pdf (24.03.2017)
Finalised Product Information:	NL_H_2939_001_FinalPI_2of6.pdf (24.03.2017)
Finalised Product Information:	NL_H_2939_001_FinalPI_3of6.pdf (24.03.2017)
Finalised Product Information:	NL_H_2939_001_FinalPI_4of6.pdf (24.03.2017)
Finalised Product Information:	NL_H_2939_001_FinalPI_5of6.pdf (24.03.2017)
Finalised Product Information:	NL_H_2939_001_FinalPI_6of6.pdf (24.03.2017)