EU/3/18/1995

About

On 21 March 2018, orphan designation (EU/3/18/1995) was granted by the European Commission to Loxo Oncology Limited, United Kingdom, for larotrectinib for the treatment of salivary gland cancer.

The sponsorship was transferred to Bayer AG - Germany, in June 2018.

Key facts

Active substance
Larotrectinib
Disease / condition
Treatment of salivary gland cancer
Date of decision
21/03/2018
Outcome
Positive
Orphan decision number
EU/3/18/1995

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

Bayer AG
Kaiser-Wilhelm-Allee 3
51368 Leverkusen
Germany
E-mail: clinical-trials-contact@bayer.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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