EU/3/12/968

About

On 5 March 2012, orphan designation (EU/3/12/968) was granted by the European Commission to Envestia Limited, United Kingdom, for human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (also known as KBSA301) for the treatment of pneumonia caused by Staphylococcus aureus.

The sponsorship was transferred to Global Regulatory Limited, United Kingdom, in November 2017.

Key facts

Active substance
Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin
Disease / condition
Treatment of pneumonia caused by Staphylococcus aureus
Date of decision
05/03/2012
Outcome
Positive
Orphan decision number
EU/3/12/968

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Global Regulatory Limited
266 - 268 Wickham Road
Croydon CR0 8BJ
United Kingdom
Tel: +44 20 86540555
E-mail: info@globalregulatoryltd.co.uk

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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