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Published on 21 March 2011

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CHMP announces indication extensions for four drugs

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The Committee for Medicinal Products for Human Use announced positive opinions for the extension of therapeutic indications to a number of medicines already authorised in the EU at its March meeting.

The gathering, which was held from 14-17 March, 2011, learnt that indications for Herceptin (trastuzumab) will be extended.

Patients with HER2-positive early breast cancer can now be treated with trastuzumab in combination with adjuvant chemotherapy consisting of paclitaxel or docetaxel following adjuvant chemotherapy with doxorubicin and cyclophosphamide, or consisting of docetaxel and carboplatin.

Indication for Lucentis  (ranibizumab) has been extended to treatment to visual impairment due to macular oedema secondary to retinal vein occlusion.

Remicade (infliximab) has now been approved for severe Crohn’s disease patients with moderately to severely active disease in addition to severe Crohn’s diease, as before.

Indiation for the orphan medication Revatio (sildenafil) has likewise been extended to paediatric patients aged one to 17 years with pulmonary arterial hypertension.



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