Information on excipients in homeopathic medicinal products
messages in brief
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22/10/2020
Excipients used in the manufacture of active ingredients (such as lactose, whey, sucrose, honey, ethanol, glycerol) that may be present in trace amounts in the finished product have been re-evaluated according to the Excipients guideline and no longer need to be mentioned in the product information if they are less than or equal to a certain threshold.
Above this threshold, a listing in FI and GI is required and the corresponding warnings must be mentioned in the product information.
No mention in the product information if the amount is the excipient used in the production of the active ingredient:
| Lactose | less than or equal to 1mg per daily maximum dose |
| Sucrose | less than or equal to 1mg per daily maximum dose |
| Invert sugar (honey) | less than or equal to 1 mg per daily maximum dose |
| Ethanol (oral, parenteral, inhalation) | less than or equal to 50mg per daily maximum dose (according to ICH-Q3C) |
| Glycerol | less than or equal to 10 mg per daily maximum dose |
Affected marketing authorization holders may update the product information with the next variation application in this regard.
Further inquiry note
Page last modified:
22/10/2020