European Union CPMP June Meeting

18 June 1995

On June 6-8, the sixth meeting of the new European Union Committee on Proprietary Medicinal Products considered the risk/benefit of anorectic agents in relation to recent findings of primary pulmonary hypertension under Article 12 of Directive 75/319/EEC. Companies will have the opportunity for a hearing at the CPMP July meeting.

It also considered the risk/benefit of Rhone-Poulenc Rorer's quinolone antibiotic sparfloxacin, related to phototoxicity and cardiotoxicity under Article 12. Sparfloxacin is marketed in France and Luxembourg, where warnings and restrictions to indications have already been implemented.

Progress on two centralized procedures converted from concertation was reviewed, two multistate applications in conformity with the rules applying before 1995 received positive opinions, and consensus was reached on the place of growth hormone in replacement therapy in adults. Detailed scientific advice before the submission of an application was prepared to be given to a company to facilitate and speed up appropriate drug development. There was also discussion with another company, and advice will be prepared.

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