Proveca Pharma Ltd launches first product in another major European market – France
Proveca Pharma Ltd launches in France
Proveca Pharma Ltd, a pharmaceutical company that specialises
in medicines for children can now provide Sialanar® (glycopyrronium bromide) to children with chronic neurological disorders who suffer from severe sialorrhea in France.
Sialanar® (320 mcg/ml glycopyrronium, oral solution) received a European Paediatric Use Marketing Authorisation (PUMA) on 15th September 2016 for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Full product information on Sialanar® can be found
here: https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar®#product-information-section
Dr Rondeau (co investigateur of the SALIVA trial – neuro- pediatrician at the center for early medico-social action (CAMSP) of the Rouen University Hospital), commented:
“The medical and paramedical teams who manage children with neurodevelopmental disorders impatiently awaited the arrival in France of a treatment adapted to the management of drooling in children. The use of Sialanar® during the SALIVA clinical study was a great opportunity for us to discover and try the product. The study against placebo has measured the impact on drooling reduction, associated adverse events and activities such as social interactions. After this first step which give us the possibility to use the product at the hospital, we are strongly hoping a quick and favorable outcome for reimbursement in community pharmacies.”
Dr Simon Bryson, CEO and founder of Proveca Ltd, commented:
“We are delighted to announce that Sialanar® is now accessible to children in France. As in many countries across the world there is a high unmet need to manage this condition and improve the quality of the lives of patients and their carers. This is a significant country in the European Union for Sialanar® and as part of our commercialisation strategy to optimise access of our products across the world.”
About Proveca Ltd
Proveca Ltd is a pharmaceutical company based in Europe specialising in the development and licensing of medicines to address the unmet medical needs of children. The team at Proveca are seeking to improve the lives of children, many of whom require long-term drug treatment for chronic conditions. Working with clinicians, parents, carers and children, Proveca are leading the way in providing licenced, clinically proven, medicines that are tailored to the specific needs of children.
For further information about Proveca Ltd, please visit: www.proveca.com
UK-SIA-23-0015
Created February 2023