Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) - Scientific guideline
Table of contents
This guidance describes chemical, toxicological, pharmacological and pharmacokinetic properties of unsaturated pyrrolizidine alkaloids (PAs). It sets out recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs.
Keywords: Herbal medicinal products, pyrrolizidine alkaloids
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Overview of comments received on draft revised Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) (EMA/HMPC/893108/2011 Rev. 1) (PDF/235.77 KB)
First published: 01/10/2021
EMA/HMPC/3914/2021 -
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Draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids - Revision 1 (PDF/462.3 KB)
Draft: consultation closed
First published: 14/08/2020
Consultation dates: 15/08/2020 to 15/11/2020
EMA/HMPC/893108/2011 Rev. 1 -
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Call for scientific data for use in HMPC assessment work on ‘Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) - First version’ (PDF/76.52 KB)
Draft: consultation closed
First published: 28/02/2019
Consultation dates: 28/02/2019 to 31/08/2019
EMA/HMPC/39600/2019 -
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Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) - First version (PDF/459.55 KB)
Adopted
First published: 22/12/2014
Last updated: 22/12/2014
EMA/HMPC/893108/2011 -
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Overview of comments received on the second draft Public statement on the use of herbal medicinal products containing toxic unsaturated pyrrolizidine alkaloids (PAs) (PDF/337.79 KB)
First published: 22/12/2014
Last updated: 22/12/2014
Consultation dates: 22/12/2014 to 31/03/2015
EMA/HMPC/577756/2014 -
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Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) (PDF/752.55 KB)
Draft: consultation closed
First published: 14/11/2013
Last updated: 14/11/2013
Consultation dates: 14/11/2013 to 15/02/2014
EMA/HMPC/893108/2011 2nd draft -
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Overview of comments received on the draft Public statement on the use of herbal medicinal products containing toxic unsaturated pyrrolizidine alkaloids (PAs) (PDF/576.82 KB)
First published: 14/11/2013
Last updated: 14/11/2013
EMEA/HMPC/411398/2006 -
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Draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PDF/316.9 KB)
Draft: consultation closed
First published: 25/10/2012
Last updated: 25/10/2012
Consultation dates: 25/10/2012 to 15/02/2013
EMA/HMPC/893108/2011