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Drugs and Health Products

Gemmotherapy

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.
  • The use of the electronic Product License Application form (ePLA) is not possible for products associated with this monograph.

Date

June 24, 2013

Proper name(s), Common name(s), and Source material(s)

Table 1 Products may contain one or more of the following ingredients

Proper name(s) Common name(s) Source material(s)
Abies alba Silver fir Buds;
Young shoots
Abies balsamea Balsam fir Buds; Young shoots
Acer campestre Field maple;
Hedge maple
Buds
Aesculus hippocastanum Horse chestnut Buds
Alnus glutinosa Alder;
Black alder;
European alder
Buds
Alnus incana Mountain alder Buds
Ampelopsis veitchii Boston ivy;
Virgin vine;
Wild woodvine
Young shoots
Betula alba;
Betula pubescens
White birch;
Downy birch
Buds;
Catkin;
Inner bark of stems/roots;
Radicles;
Sap
Betula verrucos;
Betuala pendula
European white birch;
Silver birch
Buds;
Seeds;
Sap
Buxus sempervirens Boxwood Young shoots
Calluna vulgaris Heather Young shoots
Carpinus betulus Hornbeam Buds
Castanea vesca/sativa Chestnut;
Sweet chestnut;
Spanish chestnut
Buds
Cedrus libani Cedar of Lebanon Young shoot
Cercis siliquastrum Judas tree Buds
Citrus limonum Lemon;
Lemon tree
Stem bark;
Young shoot
Cornus sanguinea Dogwood Buds
Corylus avellana Hazel Buds
Crataegus oxyacantha/laevigata Hawthorn Young shoot;
Buds
Equisetum arvense Horsetail Young shoot
Fagus sylvatica European beech;
Common beech;
Beech
Buds
Ficus carica Fig Buds
Fraxinus excelsior Ash Buds
Ginkgo biloba Ginkgo Buds;
Leaves
Hippophae rhamnoides Sea buckthorn Buds
Ilex aquifolium English Holly;
Holly
Young shoots
Juglans regia English walnut;
Walnut;
Walnut tree
Buds
Juniperus communis Common juniper;
Juniper
Young shoots
Ligustrum vulgare Privet Young shoots
Lonicera nigra Honeysuckle Young shoots
Malus sylvestris Crab apple;
European crab apple
Buds
Morus nigra Black Mulberry Buds
Olea europaea Olive Young shoots
Pinus montana/mugo Mountain pine Buds
Platanus orientalis Oriental planetree Buds
Populus nigra Black poplar Buds
Prunus amygdalus/dulcis Almond;
Sweet almond
Buds;
Root bark (rootlet)
Quercus robur/pedunculata English Pedunculate oak Buds
Ribes nigrum Black currant Buds
Rosa canina Dog rose Young shoots
Rosmarinus officinalis Rosemary Young shoots
Rubus fruticosus Blackberry;
Bramble
Young shoots
Rubus idaeus Raspberry Young shoots
Sambucus nigra Black elder Buds
Salix alba White willow Buds; Catkins
Secale cereale Rye Root bark (rootlet)
Sequoia gigantea Giant sequoia;
Giant Redwood
Young shoots
Sorbus domestica Servicetree;
Rowan tree
Buds
Syringa vulgaris Lilac Buds
Tamarix gallica Tamarisk Young shoots
Tilia tomentosa Silver linden;
Linden tree
Buds
Ulmus campestris/minor European field elm;
Elm
Buds
Vaccinium myrtillus Bilberry;
European blueberry
Buds;
Young shoots
Vaccinium vitis-idaea Ligonberry;
Cowberry;
Wine berry
Young shoots
Viburnum lantana Wayfaring tree Buds
Vinca minor Common periwinkle; Lesser periwinkle Young shoots
Viscum album European mistletoe;
Mistletoe
Young shoots
Vitis vinifera Grape;
Grape vine
Buds
Zea mays Corn;
Maize
Root bark (rootlet)

Route(s) of administration

  • Oral

Dosage form(s)

  • The acceptable pharmaceutical dosage forms are liquids only.
  • This monograph is not intended to include dosage forms such as beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of

Gemmotherapy preparation/remedy/medicine

Dose

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years)

Quantity(ies)

Medicinal ingredients with extract ratio 1:20

Maximum 37.5 mg QCE of medicinal ingredient per day.

Products containing a single medicinal ingredient:
Maximum 2.5 mg Quantity Crude Equivalent (QCE) of medicinal ingredient per drop.

Products containing multiple medicinal ingredients*:
Maximum 2.5 mg QCE of medicinal ingredients per drop (Refer to Appendix I for examples).

Medicinal ingredients with extract ratio 1:200

Maximum 56.25 mg QCE of medicinal ingredient per day.

Products containing a single medicinal ingredient:
Maximum 0.25 mg QCE of medicinal ingredient per drop.

Products containing multiple medicinal ingredients*:
Maximum 0.25 mg QCE of medicinal ingredients per drop (Refer to Appendix I for examples).

Betula (alba/pubescens/verrucosa/pendula) sap

Maximum 300 drops or 15 ml or 1 tablespoon per day.
Maximum 0.05 ml of fresh sap per drop.

*The quantity per drop and the quantity crude equivalent (QCE) of each medicinal ingredient will depend on the number of medicinal ingredients and their proportions in the product. Please refer to Appendix II for examples.

Method of preparation

The method of preparation must be one of the following:

  • PhF glycerine macerate
  • Ph. Eur.

Directions for use

All products

Take as directed by a health care practitioner.

Products containing Betula (alba/pubescens/verrucosa/pendula)sap

Drink plenty of water when using this product.

Duration of use

Statement(s) to the effect of

No statement required.

Risk information

Statement(s) to the effect of

Cautions and warnings

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindications

No statement required.

Known adverse reactions

No statement required.

Non-medicinal Ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

References reviewed

  • Andrianne P. La gemmothérapie: Médecine des bourgeons. Éditions Amyris, 2002.
  • Andrianne P. Guide de Gémmothérapie, Éditions Amyris, 2008.
  • Andrianne P. Bio Info. Éditions Changer d'R. No 83.
  • Greaves M. Gemmotherapy and Oligotherapy Regenerators of Dying Intoxicated Cells. (US): Xlibris, 2008.
  • Goetz P. Quelques éléments pratiques de gemmothérapie. Phytothérapie 2006;2:83-86.
  • Next link will take you to another Web site Fédération Européenne d'Herboristerie. 2008. [Accessed 2013 May 29 ].
  • Henry P. Gemmothérapie : Thérapeutique par les extraits embryonnaires végétaux. St.Norbert Westerlo (BE), 2008.
  • Rozencwajg J. Dynamic Gemmotherapy: Integrative Embryonie Phytotherapy, 2008.
  • Tétau M. Nouvelles cliniques de gemmothérapie. Éditions Similia, 1991.

Appendix I

Quantity per drop and quantity crude equicalent (QCE) for medicinal ingredients in various sample products based on their proportions

Example Medicinal ingredients in the product Proportion of each ingredient in the product (%) QCE (mg) per drop for ratio 1:20 (maximum 2.5 mg) QCE (mg) per drop for ratio 1:200 (maximum 0.25 mg)
1 Betula alba 100 2.5 0.25
2 Betula alba
Juglans regia
50
50
1.25
1.25
0.125
0.125
3 Alnus incana
Lonicera nigra
75
25
1.875
0.625
0.1875
0.0625
4 Abies alba
Malus sylvestris
Zea mays
33.3
33.3
33.3
0.83
0.83
0.83
0.083
0.083
0.083
5 Citrus limonum
Rosa canina
Vitis vinifera
60
30
10
1.5
0.75
0.25
0.15
0.075
0.025

Appendix II

Quantity per drop and quantity crude equivalent (QCE) for various proportions of medicinal ingredients based on product with 1 drop = 0.05mL

Proportion of medicinal ingredient in the product (%) Quantity per drop (mL) Quantity crude equivalent for ratio 1:20 (mg) Quantity crude equivalent for ratio 1:200 (mg)
10 0.005 0.25 0.025
20 0.01 0.5 0.05
30 0.015 0.75 0.075
40 0.02 1.0 0.1
50 0.025 1.25 0.125
60 0.03 1.5 0.15
70 0.035 1.75 0.175
80 0.04 2.0 0.2
90 0.045 2.25 0.225
100 0.05 2.5 0.25

Note: For proportions not represented in this table, the following calculations are required to determine the quantity per dosage unit and the quantity crude equivalent.

Calculations of QCE of medicinal ingredients (MIs):

QCE (1:20) of MI = Proportion of MI in product (in %) x QCE of all MIs (maximum 2.5 mg)

QCE (1:200) of MI = Proportion of MI in product (in %) x QCE of all MIs (maximum 0.25 mg)