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Statements

Subject Item
dbr:Pediatric_use_marketing_authorization
dbo:wikiPageWikiLink
dbr:Paediatric-use_marketing_authorisation
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dbr:Paediatric-use_marketing_authorisation
Subject Item
dbr:European_Medicines_Agency
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dbr:Paediatric-use_marketing_authorisation
Subject Item
dbr:Paediatric-use_marketing_authorisation
rdf:type
yago:Declaration106725877 yago:Message106598915 yago:WikicatEuropeanUnionDirectives yago:Communication100033020 yago:Statement106722453 yago:Pronouncement106727616 yago:Directive107170080 yago:Abstraction100002137
rdfs:label
Verordnung (EG) Nr. 1901/2006 über Kinderarzneimittel Paediatric-use marketing authorisation
rdfs:comment
Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years. Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. Die Verordnung (EG) Nr. 1901/2006 über Kinderarzneimittel ist eine Verordnung der Europäischen Union, die die Entwicklung von Medikamenten regelt unter Einbeziehung der Anwendung an Kindern und Jugendlichen (0 bis 17 Jahre). Sie trat im Januar 2007 in Kraft und soll sicherstellen, dass auch für die Behandlung von Kindern und Jugendlichen Arzneimittel verfügbar sind, deren Wirksamkeit und Unbedenklichkeit speziell für diese Zielgruppe angemessen und ethisch vertretbar untersucht wurden.
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dbc:Health_and_the_European_Union
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33654045
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1087512083
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dbr:European_Union dbr:Cheek dbr:European_Economic_Area dbc:Health_and_the_European_Union dbr:Midazolam dbr:Paediatric dbr:Iceland dbr:Liechtenstein dbr:European_Medicines_Agency dbr:Seizures
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dbpedia-de:Verordnung_über_Kinderarzneimittel
dbo:abstract
Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years. Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. In September 2011, the first drug was approved under this process. It was Buccolam, a buccal application form of midazolam for the treatment of seizures. Die Verordnung (EG) Nr. 1901/2006 über Kinderarzneimittel ist eine Verordnung der Europäischen Union, die die Entwicklung von Medikamenten regelt unter Einbeziehung der Anwendung an Kindern und Jugendlichen (0 bis 17 Jahre). Sie trat im Januar 2007 in Kraft und soll sicherstellen, dass auch für die Behandlung von Kindern und Jugendlichen Arzneimittel verfügbar sind, deren Wirksamkeit und Unbedenklichkeit speziell für diese Zielgruppe angemessen und ethisch vertretbar untersucht wurden.
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wikipedia-en:Paediatric-use_marketing_authorisation?oldid=1087512083&ns=0
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1919
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wikipedia-en:Paediatric-use_marketing_authorisation
Subject Item
dbr:Puma
dbo:wikiPageWikiLink
dbr:Paediatric-use_marketing_authorisation
dbo:wikiPageDisambiguates
dbr:Paediatric-use_marketing_authorisation
Subject Item
dbr:Midazolam
dbo:wikiPageWikiLink
dbr:Paediatric-use_marketing_authorisation
Subject Item
wikipedia-en:Paediatric-use_marketing_authorisation
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dbr:Paediatric-use_marketing_authorisation