The Commission for Medicinal Products for Human Use, the Commission for homeopathic medicines and the Commission for Herbal Medicinal Products issued recommendations on medicines - in particular medicines for children - containing ethanol (alcohol) as an excipient. The FAMHP approves these recommendations aimed to protect patients and especially children. Applicants / marketing authorisation/registration holders of such medicines are invited to take account of these recommendations.
Ethanol is used as an excipient in many medicines, including homeopathic and herbal medicines, in liquid form.
Since it would be difficult to conduct studies to determine the level of ethanol that would be acceptable and safe for children, that these medicines might contain, the Committee for Medicinal Products for Human Use, the Commission for homeopathic medicines for human and veterinary use as well as the Committee for Herbal Medicinal Products for human use has studied this issue, taking into consideration the following points:
- a medicine can be taken accidentally by children;
- the rate of metabolism of ethanol and its volume of distribution vary according to the age of children;
- the use of ethanol-containing medicines should be restricted as much as possible.
Based on these considerations, the above committees have made recommendations which are shown in the document entitled "FAMHP position on ethanol content in medicinal products used in children (Including herbal medicinal products and homeopathic medicinal products".
Applicants or marketing authorisation/registration holders of ethanol-containing medicines are invited to consider these recommendations for any new application or for existing drugs.
- Avis sur le seuil d’éthanol dans les solutions buvables administrées à l’enfant (French document - 2006).
- Ethanol in liquid preparations intended for children (American Academy of Pediatrics - PEDIATRICS Vol. 73 No.3 March 1984
- Refection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children (Committee on Herbal Medicinal Products (HMPC) – European Medicines Agency (EMA) - 14/01/2010).
- For the homeopathic medicines :email@example.com
Marie-Anne Mouyart : 02/524.82.22
- For the les herbal medicinal products:firstname.lastname@example.org
WimVervaet : 02.524.82.24
- For the other medicines:Iris Geussens: email@example.com