Klaria Sumatriptan Alginate Film Receives Marketing Authorization
Klaria has been notified by the German Federal Institute for Drug and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) that the review process has concluded, and that marketing authorization for the treatment of migraine with and without aura is granted.
The review process was led by the German Federal Institute for Drug and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and applies to markets in Germany, Italy, and Spain. Further authorizations within the EU will be through the Mutual Recognition Procedure (MRP) and Repeat Use Procedure (RUP) established between European states (including the UK) for recognition of an approved medication in any other member state.
Klaria is in licensing discussions led by Ernst and Young which would cover all major markets in the EU and most member states, including the UK, representing over 30 million patients.
