EMA Download Medicine Data Tables

The EMA Download Medicine Data Tables are the European Medicines Agency's regulatory register flattened for machines: eleven tables describing the medicines the agency oversees through its centralised procedure, published as flat rows rather than as documents. The headline medicines table carries 2,730 products across 39 documented columns - identity, active substance and INN, WHO ATC codes, MeSH therapeutic areas, the full approved indication text, and nine boolean flags covering orphan designations, PRIME priority, conditional approvals, biosimilars, generics, advanced therapies, exceptional circumstances, accelerated assessment and additional monitoring. Around it sit ten companion tables: post-authorisation procedures, referrals, paediatric investigation plans, orphan designations, PSUSAs, DHPCs, medicine supply shortages, herbal medicines, medicines for use outside the EU, and maximum residue limits for veterinary products.

Every row keys on an EMA product number - the EMEA/H/C/005243-shaped identifier - and carries its procedural dates inline: European Commission decision, committee opinion adoption, marketing authorisation, withdrawal or lapse. Get a sample of this dataset and inspect real records before committing pipeline time.

A medicines row reads as identity, regulatory posture and timeline in one flat record. Three residents of the current table, three different regulatory biographies:

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
developer_applicant_holder  UCB Pharma S.A.
marketing_authorisation     26/08/2019
last_updated                20/08/2026

Lacosamide UCB is the routine case - an authorised antiepileptic with a decade-old authorisation date and a recent touch on its record. The next two show why the flags earn their 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
developer_applicant_holder  Norgine B.V.

category                    Human
name_of_medicine            Epidyolex
ema_product_number          EMEA/H/C/004675
medicine_status             Authorised
inn                         cannabidiol
atc_code_human              N03AX
orphan_medicine             Yes
developer_applicant_holder  Jazz Pharmaceuticals Ireland Limited

Mavorixafor arrives as an orphan medicine authorised under exceptional circumstances; cannabidiol carries the orphan marker into a cannabis-derived therapy. Neither story requires opening a dossier - the boolean columns carry it, which is what makes thousand-row filters over rare-disease pipelines a query instead of a reading project.

Twenty-three core fields carry the payload, spanning identity, classification, programme flags, the authorising company and the procedural date spine. Definitions below reflect the documented column set as shipped. The tables carry thirty-nine documented columns in total; the remaining sixteen - veterinary ATC codes, suspension and refusal dates, revision counters, the medicine page pointer and the rest of the programme flags - arrive as additional fields on request.

Geography - European Union and EEA territory by construction. The medicines table holds products authorised through the bloc's centralised procedure, human and veterinary sides alike, alongside committee opinions recommending use outside the EU. Authorisations issued by individual member states live in national registers rather than here, so Europe-wide market-share claims should be scoped to the centralised Procedure population the table actually represents.

Temporal - each row carries its current regulatory state plus the date spine behind it: Commission decision, opinion adoption, authorisation, and withdrawal, expiry, revocation or lapse where applicable. First-published and last-updated stamps mark when a row entered and changed, and revision counters increment on edits - so a longitudinal read pins to revision numbers instead of hoping two extracts agree. The agency's own table-generation log begins April 2026; earlier history rests on the date columns rather than archived snapshots.

Granularity - one row per medicine product, keyed on the EMA product number. Procedure-level business refuses to be crammed into the medicines row: referrals, paediatric investigation plans, orphan designations, PSUSAs, DHPCs, shortages and MRLs each get their own table, joined back by product identifier.

Scale check as of August 2026: eleven tables; the medicines table alone runs 2,730 rows by 39 documented columns.

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

• Competitive landscape mapping - split the EU centralised register by ATC group, count authorisation 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 reading a single dossier.
• Shortage monitoring - the medicine supply shortages table turns supply disruption into a trackable series, joinable back to the medicines table by product identifier.
• Pharmacovigilance targeting - additional_monitoring isolates the cohort sitting under enhanced reporting, a ready-made denominator for safety-signal work.
• Portfolio and BD screening - holder, status and the date spine together answer who holds what, since when, and whose authorisations have 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.
• Data scientists in pharmaceuticals - typed columns, stable product-number keys and flag variables mean feature engineering starts on day one, not after a parsing project.
• Investors and quants - approval, withdrawal and suspension dates across 2,730 products form base rates for pipeline-risk and catalyst-timing models.
• Developers and builders - one identifier joins eleven tables, so integration work is join logic rather than document archaeology.

Notes that pair well with this page:

• Pharmaceuticals data hub - the pooled industry view this record sits inside, alongside chemistry, pricing and reference-drug corpora.
• EMA Download Medicine Data Tables vs EMA Medicines Catalogue - two exports of the same register; the comparison spells out which view fits which job.
• The European Medicines Agency source profile - what the agency publishes beyond these tables 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 and developer teams each do with a regulator-grade medicines register once it lands structured.