Shionogi has also submitted 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.
Twinject is available in 0.15mg/0.15ml and 0.30mg/0.30ml solution for injection in a pre-filled auto-injector syringe and is used for treating allergic reactions including anaphylaxis.
Shionogi president and chief executive officer Sapan Shah said that they are very pleased to announce that Shionogi has received a positive outcome to the Decentralized Procedure supporting European approval for Twinject.
“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 European market,” Shah said.
