EMA-consult: addendum bij kinderen over de richtlijnen voor klinisch onderzoek van geneesmiddelen voor de behandeling en profylaxe van veneuze trombo-embolie

The European Medicines Agency has released for public consultation a Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease.

This is an addendum to the Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease (EMA/CHMP/41230/2015) and the two guidelines for prophylaxis of venous thromboembolism (VTE) in surgical (EMA/CHMP/325170/2012 Rev.2) and non-surgical (EMA/CPMP/EWP/6235/04 Rev. 1) adult patients, and should be read in conjunction with these guidelines. This addendum includes guidance on paediatric clinical medicine development, highlighting paediatric specific issues and differences from the treatment and prophylaxis of venous thromboembolism in adults.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to CVSWPSecretariat@ema.europa.eu by 30 June 2019.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).