Masipro

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masitinib

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masipro, intended for the treatment of systemic mastocytosis. The company that applied for authorisation is AB Science.

The company requested a re‑examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.

This EPAR was last updated on 04/04/2018

Application details

Product details
Name
Masipro
Active substance
masitinib mesylate
International non-proprietary name (INN) or common name
masitinib
Therapeutic area (MeSH)
Mastocytosis
Anatomical therapeutic chemical (ATC) code
L01XE22
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Application details
Marketing-autorisation applicant
AB Science
Date of opinion
18/05/2017
Date of refusal of marketing authorisation
14/09/2017

Assessment history

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