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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)

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Changes over time for: COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS

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[F1COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS U.K.

Scientific name of the plant U.K.

Echinacea purpurea (L.) Moench

Botanical family U.K.

Asteraceae

Herbal substance U.K.

Purple coneflower herb

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

  • BG (bălgarski): пурпурна ехинацея, пресен стрък

  • CS (čeština): čerstvá nať třapatky nachové

  • DA (dansk): Purpursolhat, frisk urt

  • DE (Deutsch): Purpursonnenhutkraut, frisch

  • EL (elliniká): Πόα Εχινάκεας της πορφυράς

  • EN (English): purple coneflower herb

  • ES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas

  • ET (eesti keel): punane siilkübar

  • FI (suomi): kaunopunahattu, tuore verso

  • FR (français): parties aériennes fraîches d’échinacée pourpre

  • HU (magyar): bíbor kasvirág virágos hajtása

  • IT (italiano): Echinacea purpurea, pianta fresca

  • LT (lietuvių kalba): rausvažiedžių ežiuolių žolė

  • LV (latviešu valoda): purpursarkanās ehinacejas laksti

  • MT (malti): Echinacea Vjola

  • NL (nederlands): rood zonnehoedkruid

  • PL (polski): jeżówka purpurowa, świeże ziele

  • PT (português): Equinácea, partes aéreas floridas

  • RO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui

  • SK (slovenčina): echinacea purpurová, čerstvá vňať

  • SL (slovenščina): sveža zel škrlatne ehinaceje

  • SV (svenska): röd solhatt, färsk ört

  • IS (íslenska): Sólhattur

  • NO (norsk): Rød solhatt

Herbal preparation(s) U.K.

Expressed juice and dried expressed juice from fresh flowering aerial parts.

European Pharmacopoeia monograph reference U.K.

N/A

Indication(s) U.K.

Traditional herbal medicinal product for treatment of small superficial wounds.

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

Type of tradition U.K.

European.

Specified strength U.K.

10 to 20 g/100 g of expressed juice or equivalent amount of dried expressed juice in liquid or semi-solid dosage forms.

Specified posology U.K.

Adolescents over the age of 12 years, adults, elderly

Small amount of ointment is applied on the affected area 2-3 times a day.

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

Route of administration U.K.

Cutaneous use.

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

Do not use the medicinal product for more than 1 week.

If the symptoms persist during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

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

Contra-indications U.K.

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use U.K.

If signs of skin infection are observed, medical advice should be sought.

The use in children below 12 years of age is not recommended because a safe use has not been sufficiently documented.

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

None reported.

Pregnancy and lactation U.K.

There are no data on cutaneous use during pregnancy or lactation.

Products containing Echinacea should not be applied to the breast of breastfeeding women.

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

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects U.K.

Hypersensitive reactions (local rash, contact dermatitis, eczema and angioedema of the lips) may occur.

The frequency is not known.

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

Overdose U.K.

No case of overdose has been reported.]

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