Details
Product Name in the RMS: Prenome 10mg
MR Number: NL/H/2940/001
Date of outcome: 03.06.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Multiple (Copy) Application Generic Chemical Substance Prescription Only |
Active Substances |
omeprazole 10 mg |
Form | Gastro-resistant capsule, hard |
MA Holder in the RMS |
Distriquimica SA Avda. Mare de Deu de Montserrat 221 08041 Barcelona Spain |
RMS | Netherlands |
Date of last change | 19.12.2020 |
ATC-Code |
A02BC01 Omeprazole |
CMS Country | Domestic Product Name |
---|---|
Belgium | Prenome 10 mg maagsapresistente capsule, hard |
United Kingdom |
Documents | |
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PAR: | NL_H_2940_001_PAR.pdf (12.02.2015) |
PARSummary: | NL_H_2940_001_PARSummary.pdf (12.02.2015) |
FinalSPC: | NL_H_2940_001_FinalSPC.pdf (18.12.2020) |
FinalPL: | NL_H_2940_001_FinalPL.pdf (18.12.2020) |
FinalLabelling: | NL_H_2940_001_FinalLabelling.pdf (13.12.2019) |
Finalised Product Information: | NL_H_2940_001_FinalPI.pdf (16.08.2018) |