EU/3/01/077: Orphan designation for the treatment of short bowel syndrome

[Gly2]-recombinant human glucagon-like peptide


On 11 December 2001, orphan designation (EU/3/01/077) was granted by the European Commission to Pharm Research Associates (UK) Ltd, United Kingdom, for [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome.

[gly2]-recombinant human glucagon-like peptide has been authorised in the EU as Revestive since 30 August 2012.


Key facts

Active substance
[Gly2]-recombinant human glucagon-like peptide
Medicine name
Intended use
Treatment of short bowel syndrome
Orphan designation status
EU designation number
Date of designation

Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggott Street Lower
Dublin 2
D02 Y754
Co. Dublin
Tel: +1 800937970

Review of designation

During its meeting of 10-11 July 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/01/077 for Revestive (teduglutide)1 as an orphan medicinal product for the treatment of short-bowel syndrome. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained2.

1 At time of orphan designation teduglutide was known as [gly2]-recombinant human glucagon-like peptide.
2 The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the European Union (EU). This means that in the 10 years after its authorisation, similar products with a comparable therapeutic indication cannot be placed on the market.

Update history

October 2022The sponsor's address was updated.
April 2022The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch.
April 2016The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland.
October 2013The sponsorship was transferred to NPS Pharma Holdings Limited, Ireland.
September 2013Nycomed Danmark ApS changed name to Takeda Pharma A/S.
April 2008The sponsorship was transferred to Nycomed Danmark ApS, Denmark.
November 2002The sponsorship was transferred to PAREXEL International Limited, United Kingdom.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome (PDF/111.78 KB)


    First published: 26/09/2012
    Last updated: 09/09/2022

  • 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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