File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

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

TitleMedicines for children licensed by the European Medicines Agency (EMEA): The balance after 10 years
Authors
KeywordsEMEA
Marketing authorisation
Paediatrics
Issue Date2006
PublisherSpringer Verlag. The Journal's web site is located at http://link.springer.de/link/service/journals/00228/index.htm
Citation
European Journal Of Clinical Pharmacology, 2006, v. 62 n. 11, p. 947-952 How to Cite?
AbstractObjective: 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). Methods: Data on drugs authorised by EMEA were extracted from EPARs (European Public Assessment Reports). Active substance, year of approval, anatomical, therapeutic and chemical (ATC) code, indication, orphan status, ages, and registrative clinical studies characteristics were assessed. Results: The percentage of authorised substances for paediatrics is 33.3%. This percentage decreased or increased when different subsets of medicines were considered [medicines for children under 2 years (23.4%), N-ATC code drugs (6%) and orphan drugs (46.4%)]. A total of 165 trials were included in the MA dossiers of 51 drugs at the time of approval, and additional 22 studies were added to the dossiers of 12 active substances submitted for paediatric variations. PK and Efficacy/Safety studies were performed for 32 (52%) active substances, while either one PK or one Efficacy/Safety study was carried out for 43 (69%) and 45 (73%) substances, respectively. Conclusions: This report demonstrates that the total number of paediatric medicines approved by EMEA is stable over the 10-year period, while an increase in drugs to treat serious or orphan diseases has been observed. In addition, under the Centralised Procedure, a valuable number of paediatric trials have been submitted to support drug approval. © 2006 Springer-Verlag.
Persistent Identifierhttp://hdl.handle.net/10722/132870
ISSN
2015 Impact Factor: 2.71
2015 SCImago Journal Rankings: 1.096
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorCeci, Aen_HK
dc.contributor.authorFelisi, Men_HK
dc.contributor.authorBaiardi, Pen_HK
dc.contributor.authorBonifazi, Fen_HK
dc.contributor.authorCatapano, Men_HK
dc.contributor.authorGiaquinto, Cen_HK
dc.contributor.authorNicolosi, Aen_HK
dc.contributor.authorSturkenboom, Men_HK
dc.contributor.authorNeubert, Aen_HK
dc.contributor.authorWong, Ien_HK
dc.date.accessioned2011-04-04T07:57:42Z-
dc.date.available2011-04-04T07:57:42Z-
dc.date.issued2006en_HK
dc.identifier.citationEuropean Journal Of Clinical Pharmacology, 2006, v. 62 n. 11, p. 947-952en_HK
dc.identifier.issn0031-6970en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132870-
dc.description.abstractObjective: 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). Methods: Data on drugs authorised by EMEA were extracted from EPARs (European Public Assessment Reports). Active substance, year of approval, anatomical, therapeutic and chemical (ATC) code, indication, orphan status, ages, and registrative clinical studies characteristics were assessed. Results: The percentage of authorised substances for paediatrics is 33.3%. This percentage decreased or increased when different subsets of medicines were considered [medicines for children under 2 years (23.4%), N-ATC code drugs (6%) and orphan drugs (46.4%)]. A total of 165 trials were included in the MA dossiers of 51 drugs at the time of approval, and additional 22 studies were added to the dossiers of 12 active substances submitted for paediatric variations. PK and Efficacy/Safety studies were performed for 32 (52%) active substances, while either one PK or one Efficacy/Safety study was carried out for 43 (69%) and 45 (73%) substances, respectively. Conclusions: This report demonstrates that the total number of paediatric medicines approved by EMEA is stable over the 10-year period, while an increase in drugs to treat serious or orphan diseases has been observed. In addition, under the Centralised Procedure, a valuable number of paediatric trials have been submitted to support drug approval. © 2006 Springer-Verlag.en_HK
dc.languageengen_US
dc.publisherSpringer Verlag. The Journal's web site is located at http://link.springer.de/link/service/journals/00228/index.htmen_HK
dc.relation.ispartofEuropean Journal of Clinical Pharmacologyen_HK
dc.subjectEMEAen_HK
dc.subjectMarketing authorisationen_HK
dc.subjectPaediatricsen_HK
dc.titleMedicines for children licensed by the European Medicines Agency (EMEA): The balance after 10 yearsen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, I: wongick@hku.hken_HK
dc.identifier.authorityWong, I=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1007/s00228-006-0193-0en_HK
dc.identifier.pmid17021892-
dc.identifier.scopuseid_2-s2.0-33750491228en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33750491228&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume62en_HK
dc.identifier.issue11en_HK
dc.identifier.spage947en_HK
dc.identifier.epage952en_HK
dc.identifier.isiWOS:000241607900009-
dc.publisher.placeGermanyen_HK
dc.identifier.scopusauthoridCeci, A=7006836326en_HK
dc.identifier.scopusauthoridFelisi, M=6507112638en_HK
dc.identifier.scopusauthoridBaiardi, P=6603678168en_HK
dc.identifier.scopusauthoridBonifazi, F=15047380400en_HK
dc.identifier.scopusauthoridCatapano, M=6603663401en_HK
dc.identifier.scopusauthoridGiaquinto, C=7006585659en_HK
dc.identifier.scopusauthoridNicolosi, A=7006060070en_HK
dc.identifier.scopusauthoridSturkenboom, M=21743803900en_HK
dc.identifier.scopusauthoridNeubert, A=7003774960en_HK
dc.identifier.scopusauthoridWong, I=7102513915en_HK
dc.identifier.citeulike1017817-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats