Provides pan-European availability of widely used and much needed oral liquid version clobazam tablets
Wooburn Green, Buckinghamshire, 24 October 2016: Martindale Pharma, the UK-based international specialty pharmaceutical company, today announced the regulatory approval of its clobazam oral suspension product, Epaclob® in France, Ireland, Germany and Italy and Silocalm® in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP).
Epaclob/Silocalm are based on Tapclob®, the world’s first oral liquid suspension version of clobazam to receive regulatory approval, which has been available from Martindale Pharma under the tradename Tapclob since May 2013. Clobazam oral suspension is used principally as an adjunctive therapy for epilepsy with the formulation particularly suitable for children and young adults. Epaclob/Silocalm are approved in two strengths, 5mg/5ml and 10mg/5ml, and will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Commenting on the approval Michael Harris, CEO of Martindale Pharma, said: “Martindale Pharma is committed to developing and providing provide high quality innovative products to our customers and to patients in international markets. We are pleased to have received regulatory approval of our oral liquid formulation of clobazam in an additional seven European countries. Already an established product in the UK, this formulation not only allows for better ease of use, especially for paediatrics, but will allow both prescribers and patients access to a much needed safe and cost-effective licensed oral liquid formulation when required.”