Rhucin

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Refused

This medicine has been refused authorisation

recombinant human C1 inhibitor
MedicineHumanRefused
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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.

Product details

Name of medicine
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

Pharmacotherapeutic group

Other hematological agents

Application details

EMA product number
EMEA/H/C/000769
Marketing authorisation applicant
Pharming Group N.V.
Opinion adopted
13/12/2007
Refusal of marketing authorisation
22/05/2008

Assessment history

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