Commission Implementing Decision (EU) 2018/134 of 24 January 2018 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2018) 218) (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/decision/2018/134@2018-01-24/en
Contents
- Preamble
- ANNEX
- ANNEX
- (2) UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA
- Indication (1)
- Indication (2)
- Adults and elderly
- Indication (1) and (2)
- Contraindications
- Special warnings and precautions for use
- Interactions with other medicinal products and other forms of interaction
- Fertility, pregnancy and lactation
- Effects on ability to drive and use machines
- Undesirable effects
- Overdose
- Pharmaceutical particulars (if necessary)
- Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines Agency, formulated on 2 February 2016 by the Committee for Herbal Medicinal Products
Whereas:
(1) Sideritis scardica Griseb., herba can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.
(2) It is therefore appropriate to include Sideritis scardica Griseb., herba in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.
(3) Decision 2008/911/EC should therefore be amended accordingly.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
HAS ADOPTED THIS DECISION:
Article 1
Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 24 January 2018. For the Commission Vytenis Andriukaitis Member of the Commission
ANNEX
ANNEX
Decision 2008/911/EC is amended as follows:
(1) In Annex I, the following substance is inserted after Pimpinella anisum L: Sideritis scardica Griseb., herba.;
(2) In Annex II, the following is inserted after the COMMUNITY LIST ENTRY on Pimpinella anisum L:
(2) UNION LIST ENTRY ON SIDERITIS SCARDIA GRISEB., HERBA
Scientific name of the plant Sideritis scardica Griseb. Botanical family Lamiaceae (Labiatae) Herbal substance Ironwort (Sideritis herba) Common name in all EU official languages of herbal preparation BG (bălgarski): Мурсалски чай, стрък CS (čeština): nať hojníku DA (dansk): Kortkroneurt DE (Deutsch): Balkan-Gliedkraut EL (elliniká): Πόα σιδηρίτου EN (English): Ironwort ES (español): Siderita, partes aéreas de ET (eesti keel): haavarohuürt FI (suomi): raudakki, verso FR (français): Crapaudine (parties aériennes de) HR (hrvatska): očistova zelen HU (magyar): sármányvirág virágos hajtása IT (italiano): Stregonia parti aeree fiorite LT (lietuvių kalba): Timsrų žolė LV (latviešu valoda): Siderītu laksts MT (Malti): ħaxixa tas-Sideritis NL (Nederlands): (Griekse) bergthee, kruid PL (polski): Ziele gojnika PT (português): Siderite, partes aéreas RO (română): iarba de ceaiul muntelui cretan SK (slovenčina): Vňať ránhoja SL (slovenščina): zel sklepnjaka SV (svenska): Sårmynta, ört IS (íslenska): NO (norsk): Gresk fjellte Herbal preparations Comminuted herbal substance European Pharmacopoeia monograph reference Not applicable Indications Type of tradition European Specified strength Please see Specified posology. Specified posology Route of administration Oral use Duration of use or any restrictions on the duration of use Any other information necessary for the safe use
Indication (1)
Traditional herbal medicinal product used for the relief of cough associated with cold.
Indication (2)
Traditional herbal medicinal product used for the relief of mild gastrointestinal discomfort. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
Adults and elderly
Indication (1) and (2)
Single dose: Herbal tea: 2-4 g of the comminuted herbal substance in 150-200 ml of water as a herbal infusion 2-3 times daily Daily dose: up to 12 g The use in children and adolescents under 18 years of age is not recommended (see section Special warnings and precautions for use)
Indication (1)
If symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Indication (2)
If symptoms persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Contraindications
Hypersensitivity to the active substance and to other plants of the Lamiaceae (Labiatae) family.
Special warnings and precautions for use
The use in children and adolescents under 18 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.
Interactions with other medicinal products and other forms of interaction
None reported
Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended. No fertility data available.
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
None known If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.
Overdose
No case of overdose has been reported.
Pharmaceutical particulars (if necessary)
Not applicable
Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
Not applicable.