Details
Product Name in the RMS: Omecat 40 mg
MR Number: NL/H/2939/003
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 |
Dose Innova, S.L. C/ de Sant Marti, 75-97 08107 Martorelles Spain |
RMS | Netherlands |
Date of last change | 10.09.2020 |
ATC-Code |
A02BC01 Omeprazole |
CMS Country | Domestic Product Name |
---|---|
Belgium | |
Czech Republic | Omecat 40 mg gastro-resistant capsule, hard |
Germany | Omeboix 40 mg magensaftresistente Hartkapsel |
Poland | Omeboix |
Portugal | |
Romania | Omez 40 mg capsule gastrorezistente |
Spain |
Documents | |
---|---|
PAR: | NL_H_2939_003_PAR.pdf (12.02.2015) |
PARSummary: | NL_H_2939_003_PARSummary.pdf (12.02.2015) |
FinalSPC: | NL_H_2939_003_FinalSPC.pdf (29.08.2019) |
FinalPL: | NL_H_2939_003_FinalPL.pdf (02.09.2020) |
FinalLabelling: | NL_H_2939_003_FinalLabelling_1of3.pdf (13.04.2016) |
FinalLabelling: | NL_H_2939_003_FinalLabelling_2of3.pdf (13.04.2016) |
FinalLabelling: | NL_H_2939_003_FinalLabelling_3of3.pdf (13.04.2016) |
Finalised Product Information: | NL_H_2939_003_FinalPI_1of6.pdf (24.03.2017) |
Finalised Product Information: | NL_H_2939_003_FinalPI_2of6.pdf (24.03.2017) |
Finalised Product Information: | NL_H_2939_003_FinalPI_3of6.pdf (24.03.2017) |
Finalised Product Information: | NL_H_2939_003_FinalPI_4of6.pdf (24.03.2017) |
Finalised Product Information: | NL_H_2939_003_FinalPI_5of6.pdf (24.03.2017) |
Finalised Product Information: | NL_H_2939_003_FinalPI_6of6.pdf (24.03.2017) |