Cimzia (certolizumab pegol)
- Region
- 🇪🇺 EU
- Active substance
- certolizumab pegol
- Company
- UCB Pharma SA
- Status
- Refused
- Therapeutic area
- Crohn Disease
- CHMP opinion
- Wed 19 Mar 2008
- Application
- EMEA/H/C/000740
- ATC
- L04AB05
- Official record
- www.ema.europa.eu
Indication
Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARD) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Cimzia Authorised · UCB Pharma
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.