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Human Medicines
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CMDh
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Paediatric Regulation
> Article 45 and previous Worksharing
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Worksharing on Article 45
List of the active substances included in the work-sharing procedure
(March 2013)
List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
(May 2013)
Worksharing project on paediatric data
List of active substances and agreed SmPC wordings -
EU
work sharing procedure in the assessment of paediatric data
(April 2010)
