EU/3/10/760

About

This medicine is now known as niraparib.

(3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt has been authorised in the EU as Zejula since 16 November 2017.

On 4 August 2010, orphan designation (EU/3/10/760) was granted by the European Commission to Merck Sharp & Dohme Limited, United Kingdom, for (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (also known as MK-4827) for the treatment of ovarian cancer.

The sponsorship was transferred to Tesaro U.K. Limited, United Kingdom, in December 2012.

Key facts

Active substance
(3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (niraparib)
Disease / condition
Treatment of ovarian cancer
Date of decision
04/08/2010
Outcome
Positive
Orphan decision number
EU/3/10/760

Review of designation

During its meeting of 3 to 5 October 2017, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/10/760 for Zejula (niraparib1) as an orphan medicinal product for the treatment of ovarian cancer. 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 methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with ovarian cancer.The COMP recommended that the orphan designation of the medicine be maintained2.


1 Previously known as (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt.

2The 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 EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

TESARO U.K. Limited
55 Baker Street
London W1U 7EU
United Kingdom
Tel. +44 (0)2033 000105

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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