OpenLegislation

Division Specified posologyF1

United Kingdom

Original text. Later amendments are not shown.

Herbal preparations:

  1. A..

    Liquid extract (DER 1:1)

    In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

  2. B..

    Liquid extract (DER 1:1,8-2,2)

    In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.

  3. C..

    Tincture (DER 1:5)

In compresses diluted at least 1:3 with freshly boiled water.

In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

As a gargle or mouth rinse in a 2 % solution.

2 to 4 times daily

Indication (a)

The use is not recommended in children under 6 years of age (see below ‘ Special warnings and precautions for use ’ ).

Indication (b)

The use in children under 12 years of age is not recommended because there is no experience available (see below ‘ Special warnings and precautions for use ’ ).

Annotations

Textual amendments

F1

Inserted by Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 5804) (Text with EEA relevance) (2010/28/EC).