Baxalta and Sanquin receive CHMP positive opinion to begin production
NewsSanquin is now licensed to produce bulk material for HYQVIA and GAMMAGARD LIQUID 10% (marketed as KIOVIG in the EU) for the European Union, Iceland and Norway.
Baxalta Incorporated announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion licensing the production of HyQvia and Gammagard Liquid 10% (marketed as Kiovig) in the EU through the company’s manufacturing services agreement with Sanquin. Both products are indicated to treat specific types of patients with primary immune deficiency.
The positive opinion from CHMP allows Sanquin to process plasma supplied by Baxalta into bulk material for HYQVIA and GAMMAGARD LIQUID 10% in the European markets. Moreover, these additional manufacturing capabilities also allow Baxalta to optimize capacity at other facilities to serve other regions.
