Lederle-Praxis, a division of American Cyanamid, has received a "positive opinion" from the European Community's Committee on Proprietary Medicinal Products for its Hemophilus b conjugate vaccine.
Lederle said that the "positive opinion" by the CPMP is a key stage in the concertation approval process which coordinates registration of medical products throughout the EC. The decision now clears the way for approval of the vaccine, known commercially as HibTITER, in the nine EC countries where it is not licensed.
Commenting on the committee's positive recommendation, Ronald Saldarini, president of Lederle-Praxis Biological, said that the company was "extremely pleased with the outcome of the CPMP review and the concertation procedure." Furthermore, he added, "it is important that HibTITER is the first human vaccine to be evaluated and approved through the CPMP. The fact that the approval was achieved in only nine months is a testimony to the efficiency of the process and the cooperation between Lederle and the review committee."
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