Use of methyl- and propylparaben as excipients in human medicinal products for oral use - Scientific guideline
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This reflection paper addresses methyl- and propylparaben, as those are the parabens predominantly used in oral pharmaceutical formulations. The focus of this document is on possible endocrine-disrupting effects in humans.
Keywords: methylparaben, propylparaben, excipients, preservatives in medicinal products, paediatric use, endocrine disruptors
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Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use (PDF/356.85 KB)
Adopted
First published: 19/11/2015
Last updated: 19/11/2015
EMA/CHMP/SWP/272921/2012 -
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Overview of comments received on the ‘Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use’ (EMA/CHMP/SWP/272921/2012) (PDF/409.04 KB)
First published: 19/11/2015
Last updated: 19/11/2015
EMA/684369/2013 -
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Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use (PDF/213.29 KB)
Draft: consultation closed
First published: 08/05/2013
Last updated: 08/05/2013
Consultation dates: 08/05/2013 to 31/10/2013
EMA/CHMP/SWP/272921/2012