Spikevax▼ bivalent Original / Omicron BA.1 (50 micrograms/50 micrograms) dispersion for injection (elasomeran / imelasomeran): Temporary supply of product with different carton and multidose vial labels - GB Marketing Authorisation number PLGB 53720/0004
The initial supply of “Spikevax bivalent Original / Omicron” will have a different tradename (in particular the word “Bivalent” is not included), and different carton and vial labels to the licensed product, and will consist of: o Batches of vials containing 2.5 mL (5 doses) entering the supply chain from mid/end August onwards o A batch of vials containing 5 mL (10 doses) entering the supply chain from end of August o Both 2.5 mL and 5 mL vials may be circulating in the supply chain at the same time, but these batches will only differ in fill volume/number of doses per vial • To ensure continuity in supply, the MHRA has agreed for these batches to be supplied to market initially via Batch Specific Variations and later under Regulation 266 of the Human Medicines Regulations (HMR) 2012, and therefore they are approved to be used as licensed product. • An exemption granted in accordance with regulation 266(4)(a) and (b) of the Human Medicines Regulations (HMR) 2012, exempts the Marketing Author