Rhucin

Refused

This medicine has been refused authorisation

recombinant human C1 inhibitor

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.

Questions and answers on recommendation for the refusal of the marketing authorisation for Rhucin

Reference Number: EMEA/567761/2007

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

Rhucin : EPAR - Refusal public assessment report