EMA/CHMP issues positive recommendations for six new medicines

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendation for six new medicines, including a new antibiotic, for use in the European Union, and a positive scientific opinion for the use of a gel outside the EU

The CHMP gave a positive scientific opinion for Umbipro (chlorhexidine digluconate), an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies, for use in countries outside the European Union. Umbipro, from GlaxoSmithKline (LSE: GSK) was submitted to the EMA under a regulatory procedure (Article 58) that allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low-income countries outside the EU.

In addition, six medicines were recommended for marketing authorization in the EU. These recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization: