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CHMP recommends change in terms of marketing authorization for Nevanac
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The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a change to the terms of the marketing authorization for Nevanac, according to a summary of opinion from the European Medicines Agency.
The recommended change is an extended indication that states “Nevanac 3 mg/mL is indicated in adults for prevention and treatment of postoperative pain and inflammation associated with cataract surgery [and] reduction in the risk of preoperative macular edema associated with cataract surgery in diabetic patients,” the opinion said.
Once the indication has been approved by the European Commission, recommendations for the use of Nevanac (nepafenac ophthalmic suspension, Novartis) will be described in an updated summary of product characteristics and published in a revised European public assessment report.