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AMES Test

For the traditional use according to § 109a of the AMG, the companies have, as is well known, until 31.12.2008 to make their "Transfer requests" according to § 39a of the AMG.

An AMES test is therefore required for the corresponding genotoxicity studies for the drugs.
The Phytopharmaceutical Cooperation coordinates the AMES tests of various drugs according to the “Bracketing & Matrixing” method.

This method is now recognised in a Concept Paper at the EMEA. You can find the link to this "Paper" at:
www.emea.europa.eu/docs/...

We have carried out AMES tests on the following drugs (a total of 98-extract preparations):

- Anguratae
- Cynara (Artichoke)
- Valerian (Baldrian)
- Berberis
- Birch leaves (Betula)
- Bittersweet stalks (Dulcamara e stip.)
- Nettle (Urtica) + root herb
- Marshmallow (Althaea radix)
- Ginkgo
- Ginseng
- Goldenrod (Solidago)
- Hops (lupuli humuli)
- St. John's Wort (Hypericum)
- Chamomile
- Garlic (Allii sativi e bulb.)
- Caraway (Carvi Fruct.)
- Pumpkin Seed Oil
- Pine oil (oleum pini pumilionis)
- Milk thistle (Cardui mariae fruc.)
- Balm
- Mistletoe (Viscum)
- Passiflora
- Primula
- Rosemary
- Horse chestnut seeds (Hippocastani semen)
- Sabal
- Sage
- Liquorice (Liquiritia)
- Devil's Claw
- Thyme
- Hawthorn leaves and flowers / Crataegus fol. cum flor.)
- Hawthorn berries (e Crataegi Fruct .)
- Milk Thistle Combination / Curcuma

Author: Cornelia Schwöppe

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