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.
|Disease / condition||
Treatment of acute myeloid leukaemia
|Date of decision||
|Orphan decision number||
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 orphan medicine assessment report .
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.