Burdie65 schreef op 4 april 2018 00:07:
Om een antwoord te krijgen op de vraag wanneer Ruconest voor kinderen 2-14 jaar gebruikt kan worden heb ik de EMA de volgende vraag voorgelegd op 20-02-2018
Original request: When will be made an adoption for paediatric use of Ruconest?
In order to use Ruconest for HAE patients between 2-14 years old, I would like to know from which date onwards these patients can be use this plasma free medicine. (Conestat alfa) PIP number EMEA-000367-PIP01-08-M06
Antwoord van de EMA ontvangen op 19-03-2018 (was in de lage prioriteit box terecht gekomen van mijn e-mail vandaar nu pas hier bericht!)
Dear Mr...,
Thank you for your query of 20 February regarding the medicine Ruconest (conestat alfa).
In the EU, Ruconest is currently authorised to treat attacks of hereditary angioedema only in adults and adolescents. It is not authorised for the treatment of children between 2 and 14 years of age, and to date, the European Medicines Agency (EMA) has not received a request for marketing authorisation for Ruconest in this patient population.
Although the company that markets Ruconest has not submitted an application for marketing authorisation in young children, it has submitted a so-called paediatric investigation plan (PIP) and the document you are referring to is the EMA decision on this PIP.
Companies developing a medicine are required by EU law to have a paediatric investigation plan, which details how they will investigate the effects of the medicine in children. Once the company has completed the studies in children outlined in the PIP, it may submit an application for a change to the marketing authorisation to include treatment of young children. Should the company decide to submit an application for marketing authorisation to EMA, this will be published on the following web page:
www.ema.europa.eu/ema/index.jsp?curl=...We hope you find this information useful. We would be grateful if you could take part in a short survey on our service, which you can access through the following link:
ec.europa.eu/eusurvey/runner/AskEMAKind regards,
Marialuisa Spanu