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Roche receives positive CHMP opinion on RoActemra indication extension

The Committee for Medicinal Products for Human Use, CHMP, adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product RoActemra from Roche. The CHMP adopted a new indication as follows: RoActemra in combination with methotrexate is indicated for the treatment of juvenile idiopathic polyarthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.