North American Vaccine Announces that Marketing Authorization for DTaP-IPV Is Approved for Several European Countries
BELTSVILLE, MD, June 11, 1998 /PRNewswire/ -- North American Vaccine (AMEX: NVX) announced today that it has been advised that the registration process for marketing authorization of its DTaP-IPV vaccine has been satisfactorily completed in several European countries, including Germany and Austria. The product will be available for launch following receipt of the national marketing authorizations in each participating country, which should be issued shortly. In addition to Germany and Austria, other participating countries include Sweden and Finland. The DTaP-IPV vaccine had previously been approved in Denmark and has been on the market in that country since the first quarter of 1997. The Company has appointed Chiron-Behring to market and distribute the DTaP-IPV product in Germany and Austria. Statens Serum Institut, Copenhagen, Denmark, holds the product registrations and will market and distribute the product in the Scandinavian countries.
"This is an important milestone for the Company as it expands its product base and marketing presence in Europe," stated Sharon Mates, President of North American Vaccine. "We look forward to the successful commercialization of this product as well as others both in Europe and the United States."
As previously announced in May 1998, North American Vaccine has been advised by the U.S. Food and Drug Administration that CERTIVA(TM), its combined diphtheria, tetanus and acellular pertussis vaccine, is nearing completion of the review process for licensure in the United States. |