EU/3/00/005: Orphan designation for the treatment of acute myeloid leukaemia
gemtuzumab ozogamicin
Table of contents
Overview
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 |
Positive
|
EU designation number |
EU/3/00/005
|
Date of designation |
18/10/2000
|
Sponsor |
Pfizer Europe MA EEIG |
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
.
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: