Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC) (c. 911)

ANNEX II U.K.

[F1 COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L U.K.

Scientific name of the plant U.K.

Calendula officinalis L.

Botanical family U.K.

Asteraceae

Herbal substance U.K.

Calendula flower

Common name in all EU official languages of herbal substance U.K.

• BG (bălgarski): Невен, цвят

• CS (čeština): Měsíčkový květ

• DA (dansk): Morgenfrueblomst

• DE (Deutsch): Ringelblumenblüten

• EL (elliniká): Άνθος καλέντουλας

• EN (English): Calendula flower

• ES (español): Flor de caléndula

• ET (eesti keel): Saialilleõisik

• FI (suomi): Tarhakehäkukan kukka

• FR (français): Souci

• HU (magyar): A körömvirág virága

• IT (italiano): Calendula fiore

• LT (lietuvių kalba): Medetkų žiedai

• LV (latviešu valoda): Kliņģerītes ziedi

• MT (malti): Fjura calendula

• NL (nederlands): Goudsbloem

• PL (polski): Kwiat nagietka

• PT (português): Flor de calêndula

• RO (română): Floare de gălbenele (calendula)

• SK (slovenčina): Nechtíkový kvet

• SL (slovenščina): Cvet vrtnega ognjiča

• SV (svenska): Ringblomma, blomma

• IS (íslenska): Morgunfrú, blóm

• NO (norsk): Ringblomst

Herbal preparation(s) U.K.

A. Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v). U.K.

B. Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v). U.K.

C. Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v). U.K.

European Pharmacopoeia monograph reference U.K.

Calendula flower – Calendulae flos (01/2005:1297)

Indication(s) U.K.

(a) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds. U.K.

(b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat. U.K.

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

Type of tradition U.K.

European

Specified strength U.K.

Please see ‘ Specified posology ’ .

Specified posology U.K.

Herbal preparations:

A.

Liquid extract (DER 1:1)

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

B.

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

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

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 ’ ).

Route of administration U.K.

Cutaneous and oromucosal use.

Duration of use or any restrictions on the duration of use U.K.

Compresses: remove after 30-60 minutes

All herbal preparations: If the symptoms persist after 1 week during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use U.K.

Contraindications U.K.

Hypersensitivity to members of the Asteraceae ( Compositae ) family.

Special warnings and precautions for use U.K.

Indication (a)

The use in children under 6 years of age is not recommended because there is no experience available.

Indication (b)

The use in children under 12 years of age is not recommended because there is no experience available.

If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction U.K.

None reported.

Pregnancy and lactation U.K.

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines U.K.

Not relevant.

Undesirable effects U.K.

Skin sensitisation. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose U.K.

None reported.]

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).