Latest hum. ProductsDetails
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 | 16.02.2019 |
| 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 (15.05.2017) |
| FinalPL: | NL_H_2940_003_FinalPL.pdf (15.05.2017) |
| FinalLabelling: | NL_H_2940_003_FinalLabelling.pdf (15.05.2017) |
| Finalised Product Information: | NL_H_2940_003_FinalPI.pdf (16.08.2018) |
