Rhucin
recombinant human C1 inhibitor
Table of contents
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.
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
|
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-authorisation applicant |
Pharming Group N.V.
|
| Date of opinion |
13/12/2007
|
| Date of refusal of marketing authorisation |
22/05/2008
|
Assessment history
-
List item
Rhucin : EPAR - Refusal public assessment report (PDF/768.59 KB)
First published: 27/06/2008
Last updated: 27/06/2008 -
List item
Questions and answers on the recommendation for the refusal of the marketing authorisation for Rhucin (PDF/35.01 KB)
First published: 13/12/2007
Last updated: 13/12/2007