EU/3/00/005: Orphan designation for the treatment of acute myeloid leukaemia

gemtuzumab ozogamicin


On 18 October 2000, orphan designation (EU/3/00/005) was granted by the European Commission to Wyeth Europa Limited, United Kingdom, for gemtuzumab ozogamicin for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to Pfizer Limited, United Kingdom, in March 2013.

Gemtuzumab ozogamicin has been authorised in the EU as Mylotarg since 19 April 2018.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in July 2018.


Key facts

Active substance
gemtuzumab ozogamicin
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Brussels-Capital Region

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Mylotarg at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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