Tag Archives: traditional use

EMA Publishes Herbal Monograph for Glycyrrhiza glabra L.,

Posted on October 29, 2011 by admin| Leave a comment

EMA Publishes Herbal Monograph for Glycyrrhiza glabra L.,

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix (liquorice root)
i) Herbal substance Not applicable.
ii) Herbal preparations

a) Comminuted herbal substance

b) Soft extract (DER 1:0.4-0.5), extraction solvent water

c) Soft extract (DER 3:1), extraction solvent water

Comminuted herbal substance as a herbal tea for oral use.
Herbal preparations in liquid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.


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EMA Publishes Comments Received on Herbal Monograph, Symphytum Officinale L., radix

Posted on October 28, 2011 by admin| Leave a comment

EMA Publishes Comments Received on Herbal Monograph, Symphytum Officinale L., radix

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Symphytum officinale L., radix (comfrey root)
i) Herbal substance Not applicable.
ii) Herbal preparations Liquid extract (DER 2:1), extraction solvent ethanol 65% V/V.

Herbal preparations in semi-solid dosage forms for cutaneous use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Traditional herbal medicinal product used for the symptomatic treatment of minor sprains and bruises.
The product is a traditional herbal medicinal product for use in the specified indication



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community Herbal Monograph on Fraxinus Excelsior L

Posted on October 27, 2011 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Fraxinus Excelsior L

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium (ash leaf)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Comminuted herbal substance

Comminuted herbal substance as herbal tea (decoction or infusion) for oral use. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba

Posted on September 1, 2011 by admin| Leave a comment

EMA Publishes Community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba

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Traditional use
With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Tanacetum parthenium (L.) Schulz Bip., herba (feverfew)
i) Herbal substance Not applicable.
ii) Herbal preparations Powdered herbal substance

Herbal preparation in solid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

 

Traditional herbal medicinal product for the prophylaxis of migraine headaches after serious conditions have been excluded by a medical doctor.
The product is a traditional herbal medicinal product for use in specified indication exclusively



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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Community Herbal Monograph on Valeriana Officinalis L., Radix and Humulus Lupulus L., flos

Posted on July 19, 2011 by admin| Leave a comment

EMA Publishes Community Herbal Monograph on Valeriana Officinalis L., Radix and Humulus Lupulus L., flos

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Well-established use

With regard to the marketing authorisation application of Article 10a of Directive 2001/83/EC as amended
Fixed combinations of Valeriana officinalis L., radix (valerian root) and Humulus lupulus L., flos (hop strobiles)
i) Herbal substances
Not applicable
ii) Herbal preparations used in fixed combinations of
a) Dry extracts of valerian root (DER 4-8:1, methanol 45-51% m/m) and hop strobiles (DER 3-10:1, methanol 40-51% m/m)
b) Dry extracts of valerian root (DER 4-7:1, ethanol 70% v/v) and hop strobiles (DER 4-8:1, methanol 40% v/v)

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Fixed combinations of Valeriana officinalis L., radix (valerian root) and Humulus lupulus L., flos (hop strobiles)
i) Herbal substances
Not applicable
ii) Herbal preparations used in fixed combinations of
- Liquid extract (DER 1:6.3) from a mixture of valerian root-hop strobiles (1:1), extraction solvent ethanol 40% v/v
- Liquid extract from a mixture (1:1) of valerian root tincture (DER 1:10), extraction solvent ethanol 53% m/m and hop strobiles liquid extract (DER 1:2.2), extraction solvent ethanol 53% m/m
- Dry extracts
a) Dry extracts of valerian root (DER 4-6:1), extraction solvent water and hop strobiles (DER 3-6:1), extraction solvent water
b) Dry extracts of valerian root (DER 5-7:1), extraction solvent methanol 45% m/m and hop strobiles (DER 5-7:1), extraction solvent water
c) Dry extracts of valerian root (DER 4-5:1), extraction solvent ethanol 60% v/v and hop strobiles (DER 5-9:1), extraction solvent water

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Community herbal monograph on Lavandula angustifolia P. Mill., flos

Posted on July 18, 2011 by admin| Leave a comment

EMA Publishes Community herbal monograph on Lavandula angustifolia P. Mill., flos

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Lavandula angustifolia P. Mill., flos
(lavender flower)
i) Herbal substance
As defined in the Ph. Eur. monograph.
ii) Herbal preparations
a) Comminuted herbal substance
b) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 50-60% v/v

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes Community Herbal Monograph for Hamamelis virginiana L., cortex

Posted on July 16, 2011 by admin| Leave a comment

EMA Publishes Community Herbal Monograph for Hamamelis virginiana L., cortex

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Hamamelis virginiana L., cortex; Hamamelidis cortex (hamamelis bark)
i)
Herbal substance
Not applicable
ii)
Herbal preparations
-Dried comminuted herbal substance
-Tincture (Ratio of herbal substance to extraction solvent 1:10), extraction solvent ethanol 45% v/v
-Dry extract (DER 5-7.7:1), extraction solvent ethanol 30% m/m

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community Herbal Monograph on Pelargonim Sidoides DC and/or Pelargonium Reniforme Curt.,radix

Posted on July 6, 2011 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Pelargonim Sidoides DC and/or Pelargonium Reniforme Curt.,radix

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (pelargonium root)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Liquid extract (DER 1:8-10), extraction solvent ethanol 11% m/m

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen

Posted on June 16, 2011 by admin| Leave a comment

EMA Publish Community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen (cola)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Powdered herbal substance
b) Liquid extract (DER 1:1), extraction solvent ethanol 60% V/V
c)Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 60% V/V

For Assistance with Registering Herbal Products in the UK or EU Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community herbal monograph on Oenothera biennis L. & Oenothera lamarckiana L., oleum

Posted on June 15, 2011 by admin| Leave a comment

EMA Publish Community herbal monograph on Oenothera biennis L. & Oenothera lamarckiana L., oleum

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With regard to the marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended
Oenothera biennis L.; Oenothera lamarckiana L., oleum (evening primrose oil)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Fatty oil obtained from seeds of Oenothera biennis L. or Oenothera lamarckiana L. by extraction and/or expression.

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EMA Publish Community Herbal Monograph for Cola Nitida (Vent.) Schott et Endl.

Posted on June 12, 2011 by admin| Leave a comment

EMA Publish Community Herbal Monograph for Cola Nitida (Vent.) Schott et Endl.

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen (cola)
i) Herbal substance
Not applicable.
ii) Herbal preparations
a) Powdered herbal substance
b) Liquid extract (DER 1:1), extraction solvent ethanol 60% V/V
c)
Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 60% V/V

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Statement on Herbal Products Containing Thujone

Posted on May 24, 2011 by admin| Leave a comment

EMA Statement on Herbal Products Containing Thujone

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During the assessments of Artemisia absinthium L. (monograph EMA/HMPC/234463/2008) and Salvia officinalis L. (monograph EMA/HMPC/331653/2008), it became apparent that the risk assessment of thujone, a major component in both herbal preparations, poses considerable uncertainties and difficulties. Thujone has been regarded as a severe neurotoxicant since 1800’s, although recently differing views have been expressed. Difficulties culminated in the determination of maximum limit of daily intakes of thujone, which in the case of Absinthii herba was set at 3.5 mg/person and in the case of sage leaf preparations 5.0 mg/person, both for a maximum duration of 2 weeks. Furthermore, the HMPC has concluded that the benefits of sage essential oil do not outweigh its risks (Public statement EMA/HMPC/41843/2009). Considering that thujone is a natural constituent of the essentials oils of a number of plants widely used, the HMPC decided to prepare a public statement on the use of herbal medicinal products containing thujone.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Community Herbal Monograph on Echinacea Angustifolia DC.,Radix

Posted on May 9, 2011 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Echinacea Angustifolia DC.,Radix

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Echinacea angustifolia DC., radix (narrow-leaved coneflower root)
i) Herbal substance Not applicable
ii) Herbal preparations
a) Comminuted herbal substance
b) Powdered herbal substance

Comminuted herbal substance as herbal tea for oral use.
Herbal preparations in solid dosage forms for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Traditional herbal medicinal product for supportive treatment of common cold.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, EMEA (EMA), Publish Draft Community List Entry on Vitis Vinifera Var. Tunctoria L., Folium

Posted on March 30, 2010 by admin| Leave a comment

Drug Regulators, EMEA (EMA), Publish Draft Community List Entry on Vitis Vinifera Var. Tunctoria L., Folium

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ENTRY TO LIST OF HERBAL SUBSTANCES, PREPARATIONS AND COMBINATIONS THEREOF FOR USE IN TRADITIONAL HERBAL MEDICINAL PRODUCTS

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, EMEA (EMA), Publish Draft Community List Entry on Vitis Vinifera Var. Tunctoria L., Folium

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