EMA FMD - Article 57 Product Data
- Heiner Oberkampf
- Konrad Krebs
Owned by Heiner Oberkampf
Download from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/data-medicines-iso-idmp-standards/public-data-article-57-database
General Information
- Website: https://www.ema.europa.eu/
- Download: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/data-medicines-iso-idmp-standards/public-data-article-57-database
- Data Version:Â
- Data Format: Excel
- Schema Version:Â
- Schema Format:Â
Alignment Specification
URI Specification
- Product: https://data.pistoiaalliance.org/idmp/ema/products/...
- Substances: should use SPOR SMS
- Route of Adm.: RMS list
- PRoduct Authorization Country: RMS list
- Marketing Authorization Holder: ORG
Transformation
| Column | Example | IDMP-O Alignment |
|---|---|---|
| Product name Product short name: brand name or the combination of the generic name and the company name | Diclofenac Orifarm | https://data.pistoiaalliance.org/idmp/ema/products/... a idmp-mprd:MedicinalProduct ;   rdfs:label "Diclofenac Orifarm"@en   + contextual product name...   + comprises a PhP   + hasAuthorization <.../DiclofenacOrifarm-Sweden-Authorization> . |
| Active substance The symbol "|" is used to separate different pharmaceutical products | Diclofenac Diethylamine | ... a idmp-php:PharmaceuticalProduct ; Â Â comprises spor-s:... |
| Route of administration | Cutaneous Use | PhP... idmp-mprd:hasDoseForm PhP...DF . PhP...DF hasRouteOfAdminstration rms-roa:... |
| Product authorisation country | Sweden | <.../DiclofenacOrifarm-Sweden-Authorization> ... rms-cnt:'Sweden' |
| Marketing authorisation holder | Orifarm Generics A/S | <.../DiclofenacOrifarm-Sweden-Authorization> ... spor-o:ORG-... |
| Pharmacovigilance system master file location | Denmark | skipped for now |
| Pharmacovigilance enquiries email address | Pharmacovigilance@orifarm.com | skipped for now |
| Pharmacovigilance enquiries telephone number | +4563952700 | skipped for now |