EU/3/00/005

About

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
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
18/10/2000
Outcome
Positive
Orphan decision number
EU/3/00/005

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 iconorphan medicine assessment report .

Sponsor's contact details

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Tel. +32 2554 6586
E-mail: orphan_enquiries@pfizer.com

Patients' organisations

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.

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