CHMP Issues Positive Opinion For Roche (RHHBY) RA Drug Label Expansion
7/28/2014 12:37:19 PM
24 July 2014
, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion recommending a variation to the terms of the marketing authorisation for the medicinal
. The marketing authorisation holder for this medicinal
product is Roche
. They may request a re
examination of the CHMP opinion, provided that they notify
the European Medicines Agency in writing of their intention within 1
5 days of receipt of the opinion.
The CHMP recommended
a new indication
severe, active and progressive
in adults not previously treated with
Detailed conditions for the use of this product wil
l be described in the updated summary of product
characteristics (SmPC), which will be published in the revised European public assessment report
(EPAR), and will be available in all official European Union languages after the variation to the
thorisation has been granted by the European Commission.
ormation, the full indications
will be as follows
RoActemra, in combination with methotrexate (MTX), is indicated for:
the treatment of severe, active and progressive rheumatoi
d arthritis (RA) in adults
not previously treated with MTX
the treatment of moderate to severe active RA in adult patients who have either responded
inadequately to, or who were intolerant to, previous therapy with one or more disease
matic drugs (DMARDs) or
tumour necrosis factor (TNF) antagonists.
In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where
continued treatment with MTX is inappropriate.
RoActemra has been shown to reduce the rate o
f progression of joint damage as measured by X
ray and to improve physical function when given in combination with methotrexate.
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