<p>On 15 November 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 CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn’s disease. The company that applied for authorisation is UCB Pharma SA.</p><p>The applicant requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.</p>
Therapeutic Indication
N/A
Therapeutic Area (MeSH)
ATC Code
L04AB05
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| certolizumab pegol | N/A | certolizumab pegol |
EMA Name
Cimzia
Medicine Name
Cimzia
Aliases
N/ANo risk management plan link.