Needs for paediatric medicines
The European Medicines Agency is developing an inventory of the needs for paediatric medicines, to help medicinal-product developers identify opportunities.
In addition to its benefits for industry, the inventory aims to enable:
- the Paediatric Committee (PDCO) to judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals;
- healthcare professionals and patients to have an information source available to support their decisions as to which medicines to choose.
The need for the inventory stems from a report adopted by the PDCO in December 2010, on the survey of all paediatric uses of medicines in Europe:
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Report on the survey of all paediatric uses of medicinal products in Europe: Executive summary
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Report on the survey of all paediatric uses of medicinal products in Europe: Questions and answers
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Report on the survey of all paediatric uses of medicinal products in Europe: Full report
The Agency is publishing lists of medicines by therapeutic class one by one in the tables below. Each list is open for comments for two months after publication.
This project builds on an earlier exercise to establish paediatric needs, which the former Paediatric Working Party carried out between 2001 and 2007. The outcome of this exercise is also included in the tables below. This earlier exercise was conducted according to the
European Medicines Agency / Paediatric Working Party procedure for identifying paediatric needs
.
Off-label use in children
The Agency has also produced a report on the off-label use of medicines in children. This explains that off-label use is associated with more adverse reactions to medicines for children and that adverse reactions in children may be more severe or different from what is known in adults.
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Inventory of paediatric medicines - Cardiovascular therapeutic area (PDF/99.54 KB)
Adopted
First published: 25/04/2013
Last updated: 25/04/2013
Legal effective date: 07/12/2012
Consultation dates: 30/08/2012 to 30/10/2012
EMA/PDCO/246339/2013 -
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Draft inventory of paediatric medicines - Cardiovascular therapeutic area (PDF/117.68 KB)
Draft: consultation closed
First published: 30/08/2012
Last updated: 30/08/2012
Consultation dates: 30/08/2012 to 30/10/2012
EMA/550070/2012 -
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Assessment of the paediatric needs - Cardiovascular products (PDF/66.48 KB)
Adopted
First published: 01/10/2006
Last updated: 01/10/2006
EMEA/439649/2006 -
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Overview of comments received on list of paediatric needs – Cardiovascular products (PDF/112.83 KB)
First published: 10/10/2006
Last updated: 10/10/2006
EMEA/404310/2006
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Inventory of paediatric therapeutic needs - Endocrinology (PDF/83.35 KB)
Adopted
First published: 19/08/2015
Last updated: 19/08/2015
EMA/PDCO/52553/2015 -
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Draft inventory of paediatric therapeutic needs - Endocrinology (PDF/130.2 KB)
Draft: consultation closed
First published: 11/05/2015
Last updated: 01/06/2015
Consultation dates: 08/05/2015 to 06/07/2015
EMA/PDCO/52553/2015 Corr.1 -
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Overview of comments received on the list of paediatric needs – Endocrinology (PDF/75.29 KB)
First published: 19/08/2015
Last updated: 19/08/2015
EMA/471041/2015
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Inventory of paediatric therapeutic needs: gastroenterology (PDF/88.5 KB)
Adopted
First published: 28/10/2015
Last updated: 28/10/2015
EMA/PDCO/552359/2015 -
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Response to public comments received on the inventory of paediatric therapeutic needs: gastroenterology (PDF/155.41 KB)
First published: 28/10/2015
Last updated: 28/10/2015
EMA/PDCO/470078/2015 -
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Inventory of paediatric therapeutic needs - Gastroenterology (PDF/89.29 KB)
Draft: consultation closed
First published: 11/05/2015
Last updated: 01/06/2015
Consultation dates: 08/05/2015 to 06/07/2015
EMA/PDCO/43828/2015 Corr.1 -
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Assessment of the paediatric needs - Gastroenterology (PDF/151.36 KB)
Adopted
First published: 01/10/2007
Last updated: 01/10/2007
EMEA/527934/2007
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Assessment of the paediatric needs - Immunology (PDF/48.15 KB)
Adopted
First published: 01/09/2006
Last updated: 01/09/2006
EMEA/381922/2006 -
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Overview of comments received on list of paediatric needs - Immunology (PDF/55.27 KB)
First published: 25/09/2006
Last updated: 25/09/2006
EMEA/381452/2006
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Inventory of paediatric therapeutic needs - Infectious diseases (PDF/121.61 KB)
Adopted
First published: 08/05/2014
Last updated: 08/05/2014
Legal effective date: 11/10/2013
EMA/PDCO/287222/2012 -
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Draft inventory of paediatric medicines - Infectious diseases (PDF/125.36 KB)
Draft: consultation closed
First published: 15/05/2013
Last updated: 18/06/2013
Consultation dates: 15/05/2013 to 26/07/2013
EMA/PDCO/287222/2012 -
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Assessment of the paediatric needs - Anti-infectious therapy with focus on antimycotics, antivirals (except HIV) (PDF/49.56 KB)
Adopted
First published: 01/10/2006
Last updated: 01/10/2006
EMEA/435350/2006
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Inventory of paediatric therapeutic needs - Nephro-urology (PDF/98.66 KB)
First published: 12/09/2014
Last updated: 12/09/2014
EMA/PDCO/358806/2013 -
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Draft inventory of paediatric therapeutic needs - Nephro-urology (PDF/101.95 KB)
Draft: consultation closed
First published: 12/08/2013
Last updated: 12/08/2013
Consultation dates: 12/08/2013 to 14/10/2013
EMA/PDCO/358806/2013 -
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Assessment of the paediatric needs - Nephrology (PDF/61.95 KB)
Adopted
First published: 01/12/2006
Last updated: 01/12/2006
EMEA/13306/2007
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Draft inventory of paediatric therapeutic needs - Neurology (PDF/91.31 KB)
Draft: consultation closed
First published: 08/05/2014
Last updated: 08/05/2014
Consultation dates: 09/05/2014 to 09/07/2014
EMA/562919/2013 -
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Assessment of the paediatric needs - Epilepsy (PDF/51.21 KB)
Adopted
First published: 20/09/2006
Last updated: 20/09/2006
EMEA/377174/2006 -
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Overview of comments received on list of paediatric needs - Epilepsy (PDF/59.38 KB)
First published: 21/09/2006
Last updated: 21/09/2006
EMEA/377231/2006 -
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Assessment of the paediatric needs - Migraine (PDF/43.59 KB)
First published: 02/06/2006
Last updated: 02/06/2006
EMEA/224515/2006
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Draft inventory of paediatric therapeutic needs: Paediatric oncology (PDF/147.36 KB)
Draft: consultation closed
First published: 08/10/2014
Last updated: 08/10/2014
Consultation dates: 07/10/2014 to 30/11/2014
EMA/PDCO/381728/2014 -
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Assessment of the paediatric needs - Chemotherapy products (part I) (PDF/61.59 KB)
Adopted
First published: 01/09/2006
Last updated: 01/09/2006
EMEA/384641/2006 -
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Overview of comments received on list of paediatric needs - Oncology I (cytotoxic therapy) (PDF/92.95 KB)
First published: 01/09/2006
Last updated: 01/09/2006
EMEA/384188/2006 -
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Assessment of the paediatric needs - Chemotherapy products (part II) (PDF/40.27 KB)
Adopted
First published: 02/06/2006
Last updated: 02/06/2006
EMEA/224696/2006
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Inventory of paediatric therapeutic needs - Ophthalmology (PDF/133.78 KB)
First published: 12/09/2014
Last updated: 12/09/2014
EMA/PDCO/500455/2014 -
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Draft inventory of paediatric therapeutic needs - Ophthalmology (PDF/114.53 KB)
Draft: consultation closed
First published: 08/05/2014
Last updated: 08/05/2014
Consultation dates: 09/05/2014 to 11/07/2014
EMA/PDCO/170932/2014
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Inventory of paediatric therapeutic needs - Respiratory (PDF/101.84 KB)
Adopted
First published: 07/10/2016
Last updated: 07/10/2016
EMA/PDCO/528943/2016 -
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Response to public comments received on the ‘Inventory of paediatric therapeutic needs – Respiratory’ (PDF/116.79 KB)
First published: 07/10/2016
Last updated: 07/10/2016
EMA/528945/2016 -
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Draft inventory of paediatric therapeutic needs - Respiratory (PDF/93.28 KB)
Draft: consultation closed
First published: 11/05/2016
Last updated: 11/05/2016
Consultation dates: 11/05/2016 to 11/07/2016
EMA/244726/2016
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Assessment of the paediatric needs - Rheumatology (PDF/47.63 KB)
Adopted
First published: 02/06/2006
Last updated: 02/06/2006
EMEA/CHMP/234105/2005 -
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Overview of comments received on list on paediatric needs on rheumatology (PDF/162.42 KB)
First published: 02/06/2006
Last updated: 02/06/2006
EMEA/207562/2006