Singapore, Sept 01, 2010: Research-driven pharma company Shionogi, a US-based company of Shionogi & Co., headquartered in Osaka, Japan., has announced a positive outcome to the European Decentralized Procedure for the approval of Twinject (epinephrine auto-injector) following a communication from the UK Regulatory Authority (MHRA) as Reference Member State, and the agreement of all the Concerned Member States that the product is approvable, a notification which has been conveyed to the company’s Shionogi Ireland subsidiary.

“We are very pleased to announce that Shionogi has received a positive outcome to the Decentralized Procedure supporting European approval for Twinject,” said Dr Sapan Shah, president and CEO of Shionogi, adding, “With the achievement of this positive milestone, we are looking forward to securing partnerships that will allow Shionogi to maximize the potential for Twinject in the very important European market.”

Twinject, available in 0.15mg/0.15ml and 0.30mg/0.30ml solution for injection in a pre-filled auto-injector syringe, is indicated for the emergency treatment of severe allergic reaction (type I) including anaphylaxis to stinging insects and biting insects, allergen immunotherapy, food, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substance or exercise-induced anaphylaxis.