Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
Well-established use                                      Traditional use

                                                          With regard to the registration application of Article
                                                          16d(1) of Directive 2001/83/EC.

                                                          Verbascum thapsus L., V. densiflorum Bertol. (V.
                                                          thapsiforme Schrad), and V. phlomoides L., flos
                                                          (mullein flower)

                                                          i) Herbal substance

                                                          As defined in the Ph. Eur. monograph.

                                                          ii) Herbal preparations

                                                          Comminuted herbal substance.



3. Pharmaceutical form
Well-established use                                      Traditional use

                                                          Herbal substance or comminuted herbal substance as
                                                          herbal tea for oral use.

                                                          The pharmaceutical form should be described by the
                                                          European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                      Traditional use

                                                          Traditional herbal medicinal product used to relieve
                                                          symptoms of sore throat associated with dry cough
                                                          and cold.


1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. Monograph (ref.: 1853).



European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad)
and V. phlomoides L., flos
EMA/HMPC/611537/2016                                                                                                Page 3/6
Well-established use                                      Traditional use

                                                          The product is a traditional herbal medicinal product
                                                          for use in the specified indication exclusively based
                                                          upon long-standing use.


4.2. Posology and method of administration 3

Well-established use                                      Traditional use

                                                          Posology

                                                          Adolescents, adults and elderly

                                                          Single dose:

                                                          Herbal tea: 1.5-2 g of the herbal substance or the
                                                          comminuted herbal substance in 150 ml boiling water
                                                          as a herbal infusion three to four times daily.

                                                          Daily dose: 4.5-8 g

                                                          The use in children under 12 years of age is not
                                                          recommended (see section 4.4 ‘Special warnings and
                                                          precautions for use’).

                                                          Duration of use

                                                          If the symptoms persist longer than 1 week during
                                                          the use of the medicinal product, a doctor or a
                                                          qualified health care practitioner should be consulted.

                                                          Method of administration

                                                          Oral use

Contraindications

4.3. Contraindications

Well-established use                                      Traditional use

                                                          Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                      Traditional use

                                                          The use in children under 12 years of age has not
                                                          been established due to lack of adequate data.

                                                          If the symptoms worsen during the use of the
                                                          medicinal product, a doctor or a qualified health care
                                                          practitioner should be consulted.

3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1)


European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad)
and V. phlomoides L., flos
EMA/HMPC/611537/2016                                                                                             Page 4/6
Well-established use                                      Traditional use

                                                          If dyspnoea, fever or purulent sputum occurs, a
                                                          doctor or a qualified health care practitioner should
                                                          be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                      Traditional use

                                                          None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                      Traditional use

                                                          None known

                                                          If adverse reactions occur, a doctor or a qualified
                                                          health care practitioner should be consulted.