The registration of the product has been approved by the appropriate authority in a given country.
FDA has agreed that the product is substantially equivalent to a device already legally marketed in the U.S. (per section 510(k)); therefore the product is available for promotion and sale in the U.S. This applies to the U.S. only.
Product can be promoted and is available for sale; specific to countries where no formal regulatory approval process exists for given product.
About Novartis Vaccines
Novartis Vaccines is a leader in providing products to fight more than 20 vaccine-preventable viral and bacterial diseases. Novartis Vaccines is the division researching novel treatments.