EMA completes review of protamine-containing medicines
Potential supply shortage of protamine sulphate avoided
The European Medicines Agency has completed a review into the supply chain for protamine-containing medicinal products.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that protamine sulphate sourced from the Hokkaido Island fishing areas off the coast of Japan does not differ significantly from historical batches of the product derived from the traditional fishing grounds off Japan’s Honshu Island.
The CHMP therefore recommends that protamine sulphate sourced from the Hokkaido fishing grounds can be used for the manufacture of medicinal products both as an active substance and as an excipient. As a result, there will be no supply shortage for medicinal products containing protamine in the EU.
The CHMP also said that it is important for marketing authorisation holders of medicinal products containing protamine to investigate alternative authorised suppliers to manage any future supply issues better.
Protamine sulphate is a purified mixture of simple proteins obtained from the sperm or roe of wild salmon traditionally fished off the north-east coast of Honshu Island. It is used to counteract the anticoagulant action of heparin in the treatment of bleeding resulting from heparin overdose. It is also used to neutralise the effect of heparin, particularly in cardiac surgery. In addition the product is used as an excipient in insulin-containing products and some vaccines.
The main distributor of protamine sulphate as an active substance in the EU is a Japanese firm.
