EMA approved medicines list excel: what the register holds

One artefact answers to the phrase, and Datadory catalogs it through two products. The artefact is the European Medicines Agency's register of centrally authorised medicines: every human and veterinary product cleared through the EU centralised procedure, herbal medicines included, flattened into one spreadsheet-shaped table where a row is a medicine and a column is a fact about it.

The EMA Medicines Catalogue is the register itself, scored 10 on our rubric - a mark only 145 of the 1,744 datasets we catalog reach. Its August 2026 export counts 2,739 authorised medicines, split 2,337 human and 393 veterinary, with a documented dictionary of 34 named fields.

Identity, regulatory posture and timeline arrive together, keyed by the EMA product number - the procedure identifier formatted like EMEA/H/C/005243. Four residents of the register show the range:

name_of_medicine     Lacosamide UCB
ema_product_number   EMEA/H/C/005243
active_substance     lacosamide
atc_code_human       N03AX18  (Antiepileptics)
medicine_status      Authorised
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:

name_of_medicine     Junod
ema_product_number   EMEA/H/C/006436
active_substance     denosumab
atc_code_human       M05BX04  (Drugs for treatment of bone diseases)
holder               Gedeon Richter Plc.
ec_decision_date     19/08/2026

• a Commission decision dated 19/08/2026 landing in the same month as our cut, which tells you the register absorbs decisions within days. And the kind of row that justifies the flag columns:

name_of_medicine          Xolremdi
ema_product_number        EMEA/H/C/006496
active_substance          mavorixafor
atc_code_human            L03AX24
orphan_medicine           Yes
exceptional_circumstances Yes
holder                    Norgine B.V.

Only centrally authorised ones. The register covers medicines evaluated by EMA through the EU centralised procedure across the EU and EEA; products cleared through national procedures stay in Member State registers and never enter this file. Read any European figure against that denominator before comparing it with US counts such as openFDA's 137,000 marketed-product listings - the two numbers measure different regulatory universes, not different drug markets.

Coverage still reaches past the union's edges. One companion table lists opinions on medicines for use outside the EU, and the maximum residue limits table covers veterinary substances, so the family extends beyond centrally authorised products even while the core register stays inside them. Refused and withdrawn applications are in scope too - the failed bids alongside the wins, which matters when you want the base rate of success and not just its numerator.

Diffing consecutive cuts does most of the work. Key on ema_product_number, watch the status and flag columns, and new authorisations, suspensions and withdrawals surface the day they enter the register - exactly how competitive-intel product teams consume it.

The companion tables supply the early warnings a status flip arrives too late to give: referrals flag safety-driven reviews, PSUSAs mark active-substance assessments under EU pharmacovigilance, DHPCs capture direct-to-healthcare-professional communications, and the medicine supply shortages table turns supply-risk commentary into dated evidence.

For transatlantic portfolios, pair the register with openFDA Drug APIs: 29,300 Drugs@FDA approval records reaching back to 1939, 48,700 Orange Book entries and 20.7 million adverse-event reports. EU centralised decisions beside US approvals give one molecule two regulators' timelines on one join.

Regulatory-affairs staff watch the referral, DHPC and PSUSA tables for actions touching products they market. Competitive-intelligence teams diff register cuts to spot rival launches, veterinary expansions and withdrawals before they reach the trade press. Market researchers use the ATC-coded rows to size the centrally authorised market by therapeutic class - the market researchers use cases page walks that sizing end to end.

Two reference layers deepen those workflows. The WHO ATC/DDD Index supplies the official 2026 classification behind every atc_code_human value across all 14 anatomical groups, keeping cross-country utilisation comparisons defensible. RxNorm / RxNav Browser and APIs normalises US drug names to RXCUIs with associated NDCs across roughly 120k concepts per monthly release, so an EU product can be matched toward its American counterpart instead of eyeballed.

Because the register's quirks live in its typing, and typing is upstream of you here. Dates land as DD/MM/YYYY strings, flags as literal Yes/No, and the two products document 34 and 39 fields respectively - reconcile that by hand once and you will not want to again.

Start with a sample: name the therapeutic areas, flag combinations and date window you need, and the extract arrives shaped to your question with the field dictionary and coverage statement beside it.