METVIX PRODUCT

METVIX PRODUCT. Means the pharmaceutical formulation containing [C.I.] substantially in the form approved by the Swedish Medical Products Agency (Lakemedelsverket) (as the reference member state under the European Union mutual recognition procedure) under marketing authorization number 16338 as of the Effective Date for sale in European Union under the trademark "METVIX" and also approved by the FDA under NDA number 021415 as of the Effective Date for sale in the United States under the trademark "METVIXIA,"... including any supplements to such approvals changing the manufacturer of (a) such formulation or (b) any component thereof. View More