Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years

Adriana Ceci,Mariagrazia Felisi,Paola Baiardi,Fedele Bonifazi,Mariana Catapano,Carlo Giaquinto,Alfredo Nicolosi,Miriam Sturkenboom,Antje Neubert,Ian C. K. Wong

Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years

2006

Adriana Ceci
Mariagrazia Felisi
Paola Baiardi
Fedele Bonifazi
Mariana Catapano
Carlo Giaquinto
Alfredo Nicolosi
Miriam Sturkenboom
Antje Neubert
Ian C. K. Wong

Objective The 1995–2005 balance of EMEA activities in the field of paediatric medicines was evaluated, taking into account the number both of drugs authorised for children and paediatric studies supporting the Marketing Authorisation (MA).

Keywords:

Drug Utilization Review
Alternative medicine
Authorization
Licensure
Medicine
Orphan Drug Production
Public health
Pharmacoepidemiology
Pediatrics
Anesthesia
drug approval
Orphan drug
Internal medicine

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