- 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 agentsAssessment history
Topics
This page was last updated on