Details
Product Name in the RMS: Prenome 40mg
MR Number: NL/H/2940/003
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 40 mg maagsapresistente capsule, hard |
Poland | |
Spain | |
United Kingdom |
Documents | |
---|---|
PAR: | NL_H_2940_003_PAR.pdf (12.02.2015) |
PARSummary: | NL_H_2940_003_PARSummary.pdf (12.02.2015) |
FinalSPC: | NL_H_2940_003_FinalSPC.pdf (18.12.2020) |
FinalPL: | NL_H_2940_003_FinalPL.pdf (18.12.2020) |
FinalLabelling: | NL_H_2940_003_FinalLabelling.pdf (15.05.2017) |
Finalised Product Information: | NL_H_2940_003_FinalPI.pdf (16.08.2018) |