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EUR-Lex Pharma
Data by Publications Office of the European Union — EUR-Lex / Cellar

Search and inspect EU Commission Decisions on centralised marketing authorisations for medicinal products — the legal acts underlying every EMA EPAR (granting, varying, suspending, or withdrawing an authorisation under Regulation (EC) No 726/2004). Data sourced from EUR-Lex monthly OJ C-series summaries via the Publications Office Cellar SPARQL endpoint.

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Tools (7)

  1. listRecentWithdrawalsAndSuspensionsList the most recent EU Commission decisions that withdraw or suspend centralised marketing authorisations. Pharmacovigilance / market-access view of high-signal regulatory events. Optionally scope to a single holder.Free
  2. searchDecisionsByRegisterNumberFind every EU Commission Decision (initial grant + variations + withdrawals + suspensions) tied to a given EU Community Register number (EU/1/YY/NNNN), returned in chronological order. This is the canonical per-product identifier used by EUR-Lex summary documents. NOTE: the EMA EPAR number `EMEA/H/C/NNNNNN` is a different identifier and will NOT match here — to bridge from EMA data, search by product name first.Free
  3. searchDecisionsByProductFull-text search across EU Commission Decisions on centralised marketing authorisations by medicinal product name. Returns each decision row (issuing / modification / withdrawal / suspension / rejection) with its date, EU register number, holder, pharmaceutical form, ATC code, and a link to the parent monthly summary in EUR-Lex. Use this as the entry point when the user mentions a product name. Returns euRegisterNumbers and summaryCelexes for composition with other tools.Free
  4. searchDecisionsByINNFind EU Commission Decisions for products containing a given active substance (INN — international non-proprietary name). Returns both branded and biosimilar/generic centralised authorisations. NOTE: only 'issuing' (initial grant) decisions carry an INN field in the source data — modification, withdrawal and suspension rows do not. To track the full lifecycle of an INN, follow up with searchDecisionsByRegisterNumber on each EU register number returned.Free
  5. searchDecisionsByHolderFind EU Commission Decisions involving a given marketing authorisation holder (laboratoire titulaire — e.g. 'Roche Registration GmbH', 'Novartis Europharm Limited'). Use to answer 'recent decisions for Sanofi' or to enumerate a company's EU centralised authorisation activity.Free
  6. searchDecisionsByDateRangeList EU Commission Decisions on centralised marketing authorisations within a date range, optionally narrowed to a specific decision type. Use for regulatory-news monitoring ('what was authorised last quarter?') or compliance reporting.Free
  7. getMonthlySummaryReturn the full monthly OJ C-series summary document by its CELEX (e.g. '52026XC02325') — publication date, title, URL, and every decision row inside it grouped by section (issuing / modification / withdrawal / suspension / rejection). Use this when an agent has a summary CELEX from a prior search and wants the full source document.Free

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