Ozempic

Centrally authorised medicine · European Medicines Agency · Germany

EMA product number EMEA/H/C/004174
ATC A10BJ06

What the source publishes

Holder: Novo Nordisk A/S
Administrative status: authorised

Publisher documents

Package leaflet

Names this record is found by

Complete source data

de:ema:epar:EMEA-H-C-004174

{
  "inn": "semaglutide",
  "name": "Ozempic",
  "holder": "Novo Nordisk A/S",
  "orphan": false,
  "endDate": null,
  "generic": false,
  "smpcUrl": "https://www.ema.europa.eu/de/documents/product-information/ozempic-epar-product-information_de.pdf",
  "species": null,
  "atcCodes": [
    "A10BJ06"
  ],
  "category": "Human",
  "marketed": null,
  "useDomain": "unknown",
  "biosimilar": false,
  "leafletUrl": "https://www.ema.europa.eu/de/documents/product-information/ozempic-epar-product-information_de.pdf",
  "medicineUrl": "https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic",
  "decisionDate": "2026-06-11",
  "sourceStatus": "Authorised",
  "supplyRegime": null,
  "opinionStatus": null,
  "targetSpecies": [],
  "suspensionDate": null,
  "activeSubstance": "semaglutide",
  "advancedTherapy": false,
  "lastUpdatedDate": "2026-08-25",
  "reportTimestamp": "2026-11-08T18:01:45Z",
  "therapeuticArea": "Diabetes Mellitus",
  "emaProductNumber": "EMEA/H/C/004174",
  "authorisationDate": "2018-02-08",
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "de.ema.epar"
  },
  "patientEligibility": "not-assessed",
  "productInformation": {
    "url": "https://www.ema.europa.eu/de/documents/product-information/ozempic-epar-product-information_de.pdf",
    "language": "de",
    "updatedAt": "2026-08-25T12:02:00Z",
    "englishUrl": "https://www.ema.europa.eu/en/documents/product-information/ozempic-epar-product-information_en.pdf"
  },
  "conditionalApproval": false,
  "targetSpeciesStatus": "not-reported",
  "additionalMonitoring": false,
  "administrativeStatus": "authorised",
  "prescriptionCategory": "unknown",
  "exceptionalCircumstances": false,
  "pharmacotherapeuticGroup": "Drugs used in diabetes"
}

Centrally authorised medicines

Source: European Medicines Agency (EMA), EPAR medicines and EPAR documents website data. Product information is linked, not copied.

Retrieved: November 8, 2026
Licence: Publisher terms
Source id: de.ema.epar

Official source

What this source does not establish

Central authorisations only: every medicine EMA assessed through the centralised procedure, with its status. National, mutual-recognition and decentralised products are not in these reports.
A central authorisation is valid in every EEA country; marketing, availability and reimbursement in a particular country are not established by it, and its prescription classification is not published here, so it stays unknown.
Records join their product-information PDF on the exact EMA product number. Only EMA’s standard “<name>-epar-product-information_<language>.pdf” document counts; where the country’s language has no such PDF the English one is linked. A medicine with no such document, or more than one, has no link.
Therapeutic indications and other clinical text in the reports are not copied.
EMA’s legal notice permits commercial and non-commercial reproduction with acknowledgement of EMA as the source; its exception for third-party content leaves the status of holder-submitted text unconfirmed.
de.ema.article57 also lists centrally authorised medicines (territory "European Union"), by product name, substance, route and holder only. It carries no EMA product number, so its rows are not joined to these records; a consumer that offers both sources sees those medicines twice.

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