Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders.

Autor: Mulder J; Dutch Medicines Evaluation Board, Utrecht, Netherlands., Verjans R; Lygature, Utrecht, Netherlands., Verbaanderd C; European Medicines Agency, Amsterdam, Netherlands.; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium., Pean E; European Medicines Agency, Amsterdam, Netherlands., Weemers J; Janssen Biologics BV, Leiden, Netherlands., Leufkens HGM; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands., Pignatti F; European Medicines Agency, Amsterdam, Netherlands., de Boer A; Dutch Medicines Evaluation Board, Utrecht, Netherlands.; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands., Voest EE; Department of Molecular Oncology and Immunology, The Netherlands Cancer Institute, Amsterdam, Netherlands.; Oncode Institute, Amsterdam, Netherlands., Stoyanova-Beninska VV; Dutch Medicines Evaluation Board, Utrecht, Netherlands., Pasmooij AMG; Dutch Medicines Evaluation Board, Utrecht, Netherlands.

Publikováno v: Frontiers in medicine [Front Med (Lausanne)] 2021 Dec 09; Vol. 8, pp. 790782. Date of Electronic Publication: 2021 Dec 09 (Print Publication: 2021).

The EU paediatric regulation: effects on paediatric psychopharmacology in Europe.

Autor: Stoyanova-Beninska VV; Medicines Evaluation Board, The Hague, The Netherlands. v.stoyanova@cbg-meb.nl, Wohlfarth T, Isaac M, Kalverdijk LJ, van den Berg H, Gispen-de Wied C

Publikováno v: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology [Eur Neuropsychopharmacol] 2011 Aug; Vol. 21 (8), pp. 565-70. Date of Electronic Publication: 2010 Jul 10.