Latest hum. ProductsDetails
Product Name in the RMS: Omeplis 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 |
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 40 mg gastro-resistant capsule, hard |
| Germany | Omeboix 40 mg magensaftresistente Hartkapsel |
| Poland | Omeboix |
| Portugal | |
| Romania | Omeplis 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_1of2.pdf (04.04.2017) |
| FinalSPC: | NL_H_2939_003_FinalSPC_2of2.pdf (04.04.2017) |
| FinalPL: | NL_H_2939_003_FinalPL.pdf (07.08.2018) |
| 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) |
