The European Commission Committee for Proprietary Medicinal Products' 18th plenary meeting, July 16-17, adopted by consensus two positive opinions (Part B) for a new active substance for treatment of ovarian metastatic carcinoma, to be forwarded to the Commission. 28 positive opinions have now been adopted since May 1995, 15 under the centralized procedure and 13 under the concertation procedure. The meeting also:
- adopted by consensus a positive opinion for the third Type II variation procedure concerning a recent European Marketing Authorization, and a positive opinion for an extension of an EMA for an additional strength. 13 EMAs have now been granted, following the adoption of authorizations for Sequus Pharmaceutical's Caelyx (doxorubicin), Boehringer Mannheim's Bondronat (ibandronic acid) and Galenus Mannheim's Bonviva (ibandronic acid; Marketletters passim). European Public Assessment Reports will be available;
- assigned 10 new applications to rapporteurs and co-rapporteurs under the centralized procedure (five part A and five Part B);
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