Rhucin

RSS

recombinant human C1 inhibitor

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

Overview

On 13 December 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Rhucin 150 U/ml powder for solution for injection, intended for the treatment of acute attacks of angioedema in patients with congenital C1 inhibitor activity deficiency.

The company that applied for authorisation is Pharming Group N.V. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

This EPAR was last updated on 31/12/2009

Application details

Product details
Name
Rhucin
Active substance
recombinant human C1 inhibitor
International non-proprietary name (INN) or common name
recombinant human C1 inhibitor
Therapeutic area (MeSH)
Angioedema
Anatomical therapeutic chemical (ATC) code
B06C
OrphanOrphan

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-authorisation applicant
Pharming Group N.V.
Date of opinion
13/12/2007
Date of refusal of marketing authorisation
22/05/2008

Assessment history

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