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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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  1. Introductory Text

  2. Article 1.A list of herbal substances, preparations and combinations thereof for...

  3. Article 2.The indications, the specified strengths and the posology, the route...

  4. Article 3.This Decision is addressed to the Member States.

    1. ANNEX I

      List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC

      1. Calendula officinalis L Echinacea purpurea (L.) Moench Eleutherococcus senticosus (Rupr....

    2. ANNEX II

      1. COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

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

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

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

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

          1. (a) Traditional herbal medicinal product for the symptomatic treatment of minor...

          2. (b) Traditional herbal medicinal product for the symptomatic treatment of minor...

        8. Type of tradition

        9. Specified strength

        10. Specified posology

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

        13. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

      2. COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS...

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

        8. Type of tradition

        9. Specified strength

        10. Specified posology

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

        13. Any other information necessary for the safe use

          1. Contra-indications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

      3. COMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM.,...

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

        8. Type of tradition

        9. Specified strength

        10. Specified posology

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

        13. Any other information necessary for the safe use

          1. Contraindication

          2. Special warnings and precautions for use

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

          4. Fertility, pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars (if necessary)

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      4. A. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR....

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

        8. Type of tradition

        9. Specified strength

        10. Specified posology

          1. Adults

          2. Adolescents over 12 years of age, indication (a)

          3. Children between four and 12 years of age, indication (a)...

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

          1. Adults

          2. Adolescents over 12 years of age, indication (a)

          3. Children between four and 12 years of age, indication (a)...

        13. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars (if necessary)

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      5. B. COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR....

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

        8. Type of tradition

        9. Specified strength

        10. Specified posology

          1. Adults

          2. Adolescents over 12 years of age, indication (a)

          3. Children between four and 12 years of age, indication (a)...

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

          1. Adults

          2. Adolescents over 12 years of age, indication (a)

          3. Children between four and 12 years of age, indication (a)...

        13. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars (if necessary)

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      6. COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX...

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal preparation(s)

        4. European pharmacopoeia monograph reference

        5. Indication(s)

          1. Indication (a)

          2. Indication (b)

        6. Type of tradition

        7. Specified strength

        8. Specified posology

          1. Children over six years of age, adolescents, adults and elderly...

            1. Indication (a)

          2. Adolescents, adults and elderly

            1. Indication (b)

        9. Route of administration

        10. Duration of use or any restrictions on the duration of...

          1. Children over six years of age, adolescents, adults and elderly...

            1. Indication (a)

          2. Adolescents, adults and elderly

            1. Indication (b)

        11. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

            1. Indication (a)

            2. Indication (b)

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

            1. Indication (a)

            2. Indication (b)

          7. Overdose

          8. Pharmaceutical particulars [if necessary]

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      7. UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL,...

        1. Scientific name of the plant

        2. Botanical family

        3. Common name in all EU official languages of herbal preparation...

        4. Herbal preparation

        5. European Pharmacopoeia monograph reference

        6. Indications

          1. Indication (a)

          2. Indication (b)

          3. Indication (c)

          4. Indication (d)

        7. Type of tradition

        8. Specified strength

        9. Specified posology

          1. Indication (a)

            1. Adolescents, adults and elderly

              1. Single dose

          2. Indication (b)

            1. Adolescents, adults and elderly

              1. Single dose

          3. Indication (c)

            1. Adolescents, adults and elderly

              1. Single dose

          4. Indication (d)

            1. Adolescents, adults and elderly

        10. Route of administration

          1. Indications (a), (b) and (c)

          2. Indication (d)

        11. Duration of use or any restrictions on the duration of...

          1. Indication (a)

          2. Indications (b) and (c)

          3. Indication (d)

        12. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

            1. Indication (a)

            2. Indication (b)

            3. Indication (c)

            4. Indication (d)

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

          4. Fertility, pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars (if necessary)

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      8. COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal preparation(s)

        4. European Pharmacopoeia monograph reference

        5. Indication(s)

        6. Type of tradition

        7. Specified strength

          1. Indications 1, 2 and 3

          2. Children between 4 to 10 years of age

          3. Children between 10 to 12 years of age, adolescents between...

          4. Adolescents over 16 years of age, adults

        8. Specified posology

        9. Route of administration

        10. Duration of use or any restrictions on the duration of...

          1. Indication 1

          2. Indications 2 and 3

        11. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

      9. COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name in all EU official languages of herbal substance...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

          1. (a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic...

          2. (b) Traditional herbal medicinal product used as an expectorant in cough...

        8. Type of tradition

        9. Specified strength

        10. Specified posology

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

        13. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

      10. COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL....

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal preparation(s)

        4. European Pharmacopoeia monograph reference

        5. Indication(s)

        6. Type of tradition

        7. Specified strength

        8. Specified posology

          1. Adults and elderly

          2. Adolescents

          3. Children 6-12 years

          4. Children 3-6 years

        9. Route of administration

        10. Duration of use or any restrictions on the duration of...

        11. Any other information necessary for the safe use

          1. Contraindications

            1. Use as bath additive:

          2. Special warnings and precautions for use

            1. Cutaneous use:

            2. Use as bath additive:

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars [If necessary]

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

      11. COMMUNITY LIST ENTRY ON VITIS VINIFERA L., FOLIUM

        1. Scientific name of the plant

        2. Botanical family

        3. Herbal substance

        4. Common name of herbal substance in all EU official languages...

        5. Herbal preparation(s)

        6. European Pharmacopoeia monograph reference

        7. Indication(s)

        8. Type of tradition

        9. Specified strength

        10. Specified posology

          1. Adults and elderly

        11. Route of administration

        12. Duration of use or any restrictions on the duration of...

          1. Adults and elderly

        13. Any other information necessary for the safe use

          1. Contraindications

          2. Special warnings and precautions for use

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

          4. Pregnancy and lactation

          5. Effects on ability to drive and use machines

          6. Undesirable effects

          7. Overdose

          8. Pharmaceutical particulars (if necessary)

          9. Pharmacological effects or efficacy plausible on the basis of long-standing...

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