Martindale Pharma expands European commercial activities to include France
Launch of early access programme for Noyada, first novel oral liquid formulation of Captopril targeting paediatric cardiovascular conditions and type 1 diabetic nephropathy.
Martindale Pharma has announced the approval and supply of Noyada in France, under an ATU de' Cohorte ("Temporary Authositaion for Use") programme which will commence in June. Noyada is an oral liquid version of captopril used in the treatment of paediatric chronic heart failure. Cevidra Laboratories, a French-based pharmaceutical company which specialises in ATU programmes will distribute Noyada in France.
Martindale Pharma has also started the process to seek Marketing Authorisation Approval in France. Noyada is the only approved oral liquid formulation of captopril in Europe and has been available in the UK for 2 years. Noyada is targeted for use in children with serious cardiovascular conditions who can benefit from an oral liquid product. Noyada is a clear, colourless solution available in 100 mL amber glass bottles with child resistant and tamper evident caps, and specific dosage syringes and dosage cups to assist in administration. The doses of the oral liquid product can be easily adjusted using dosing syringes/measuring cups provided in the pack. Noyada 5 mg/5 mL and 25 mg/5mL Oral Solution is used principally in the treatment of paediatric chronic heart failure and in children between the ages of 0 and 6 years old.
Michael Harris, CEO of Martindale Pharma, said: "Martindale Pharma is committed to developing innovative presentations of known drugs that improve patients' lives and we are very pleased to have received approval to supply Noyada for paediatric patients in France. Noyada is already an established product in use in paediatric cardiology in the UK and is a hugely positive treatment option for healthcare professionals. We are delighted to be able to provide this much needed oral liquid version of captopril through the ATU de' Cohorte programme in France with Cevidra."
Noyada will be supplied under a specific protocol of therapeutic use which forms part of the ATU de' Cohorte programme. The process involves specialist physicians identifying suitable patients for Noyada and enrolling them in a registry-style programme.
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