EMA Medicines Catalogue

The European Medicines Agency's own account of every medicine it has judged through the EU's centralised procedure - published as a searchable finder and delivered by Datadory as one flat row per product. The current cut runs to roughly 2,700 authorised medicines: 2,337 human and 393 veterinary in our August 2026 snapshot, with herbal medicines carried in a dedicated view alongside. Each record keys on an EMA product number - the EMEA/H/C/005243-shaped identifier - and packs identity, classification and regulatory posture into one line: product name, INN and active substance, WHO ATC code with its pharmacotherapeutic group, MeSH therapeutic area, nine programme flags covering orphan designation, PRIME priority, conditional approval, biosimilar status and additional monitoring, the marketing-authorisation holder, and a date spine running from committee opinion through Commission decision to authorisation - or to refusal, suspension and withdrawal.

Scope note worth reading twice: this is the centralised population only. Products authorised by individual Member States live in the national registers, so Europe-wide market-share work starts from the right denominator. Get a sample of this dataset and Datadory will pull the slices - class, flag, holder, year - your question actually needs.

Identity, regulatory posture and timeline arrive together, in one row per medicine. Three residents of the register tell you the range:

category                    Human
name_of_medicine            Lacosamide UCB
ema_product_number          EMEA/H/C/005243
medicine_status             Authorised
inn                         lacosamide
atc_code_human              N03AX18
therapeutic_group           Antiepileptics
holder                      UCB Pharma S.A.
ec_decision_date            23/07/2026
authorisation_date          26/08/2019

Lacosamide UCB is the routine case - an antiepileptic with a settled authorisation and a fresh Commission decision behind it. A newer entrant:

category                    Human
name_of_medicine            Junod
ema_product_number          EMEA/H/C/006436
medicine_status             Authorised
inn                         denosumab
atc_code_human              M05BX04
therapeutic_group           Drugs for treatment of bone diseases
holder                      Gedeon Richter Plc.
ec_decision_date            19/08/2026

And the kind of row that justifies the flag columns:

category                    Human
name_of_medicine            Xolremdi
ema_product_number          EMEA/H/C/006496
medicine_status             Authorised
inn                         mavorixafor
atc_code_human              L03AX24
orphan_medicine             Yes
exceptional_circumstances   Yes
holder                      Norgine B.V.

Mavorixafor arrives as an orphan medicine authorised under exceptional circumstances - a rare-disease biography carried in two boolean columns rather than a dossier. That is the whole point of the shape: "all conditionally approved orphans under additional monitoring" resolves as a filter over a single table instead of a reading project.

Twenty core fields carry the payload, spanning four jobs: identity (name_of_medicine, ema_product_number, INN, active substance), classification (ATC code and group, MeSH therapeutic area), regulatory posture (status plus the programme flags), and accountability (holder, decision and authorisation dates, revision counter). Definitions below reflect the register's documented columns as shipped. The remaining register fields - the veterinary-side columns, the negative-event dates, the medicine-page pointer - arrive as additional fields on request, noted under the table.

Geography - the European Union and European Economic Area, by construction: every row is a medicine authorised through the bloc's centralised procedure, human and veterinary sides alike. Member-State authorisations sit elsewhere, and the catalogue says so honestly rather than pretending to pan-European coverage.

Temporal - a current register snapshot with history embedded in the rows. Each record carries its procedural date spine - Commission decision, opinion adoption, authorisation, and refusal, suspension or withdrawal where applicable - reaching back to the mid-1990s era of the centralised procedure, plus first-published and last-updated stamps and a revision number that increments on edits. Pin deliveries over time and approval-to-exit arcs reconstruct from the rows themselves.

Granularity - one row per authorised medicine, keyed on the EMA product number. Procedure-level events refuse to be crammed into the product row; they belong to the register's companion views, joined back by the same identifier.

API, files, or your warehouse. Daily, weekly, or hourly.

Pick the slices, pick the cadence, pick the landing zone - the same flat rows arrive whichever way you take them. Because every delivery pins the register as it stands, retained consecutive feeds turn a point-in-time lookup into a longitudinal record of new authorisations, quiet withdrawals and label-revision churn. The sample comes first, so column layout and row counts are settled facts before any commitment.

• Competitive landscape mapping - split the EU centralised register by ATC group, count holders per class, and separate originators from biosimilars and generics using the flags instead of name-matching heuristics.
• Orphan and special-programme surveillance - orphan_medicine, prime_priority_medicine, conditional_approval and exceptional_circumstances make rare-disease and expedited pipelines filterable without opening a single dossier.
• Approval-timing analytics - opinion-adoption, decision and authorisation dates across ~2,700 products form base rates for pipeline-risk and catalyst-timing models on EU-exposed portfolios.
• Pharmacovigilance targeting - additional_monitoring isolates the cohort sitting under enhanced reporting - a ready-made denominator for safety-signal work on the European side.
• Portfolio and BD screening - holder, status and the date spine together answer who holds what, since when, and whose authorisations lapsed - the raw material of landscape decks and diligence memos.

• Competitive-intel product teams - the register is the EU's own answer to "who else is here?", pre-normalised by the regulator rather than assembled from press releases; the competitive intel use cases page collects the workflows.
• Data scientists in pharmaceuticals - typed columns, stable product-number keys and boolean flags mean feature engineering starts on day one, not after a parsing project; see the data scientists use cases page.
• Investors and quants - decision, authorisation and withdrawal dates form event studies waiting to happen; patterns sit on the investors quants use cases page.
• Market researchers and consultants - ATC-group rollups give category reports a regulator-grade baseline; the market researchers use cases page shows the sizing angles.

• Pharmaceuticals data hub - the pooled industry view this record sits inside, alongside chemistry, pricing and reference corpora.
• EMA Download Medicine Data Tables - the register's eleven-table exposure with the procedure-level companions; the head-to-head spells out which view fits which job.
• The European Medicines Agency source profile - what the agency publishes beyond this register and how the pieces relate.
• WHO ATC/DDD Index - the classification system behind atc_code_human, useful when grouping needs defined daily doses rather than bare codes.
• openFDA Drug APIs - the US counterpart register; together they bracket transatlantic approval timelines for the same molecule.
• Persona pages - what competitive-intel, data-science, investor and market-research teams each extract once a regulator-grade medicines register lands structured.