Licensing Herbal Medicinal Products under the EU Traditional Herbal Medicinal Products Directive (THMPD)

THRs/Dossiers

The following THMP dossiers and THRs are currently available for licensing or acquisition. Dossiers are in eCDT format and ready to submit. Contract manufacturing is available for all products.

For more information please contact Plantaphile.
 

Active Dosage / Extract Posology Indication Registration
Arnica montana 20% tincture Gel Symptomatic relief of bruises, sprains and strains. Dossier only
Asparagus officinalis / Petroselinum crispum 200mg drug powder each Capsule Supporting the excretion function of the kidneys. In progress
Cineol 100/200mg essential oil Capsule Supportive treatment of bronchitis or sinusitis. Dossier only
Cucurbita pepo 122.5mg dry extract of pumpkin seeds (26-31:1) Capsules Relief of lower urinary tract symptoms. In progress
Cynara scolymus 600mg artichoke leaf aqueous dry extract (4-6:1) Coated tablet Symptomatic treatment of digestive complaints (e.g., stomachache, nausea, vomiting, bloatedness, flatulence) and hepatobilary disturbances. Dossier only
Echinacea purpurea 133.33mg dried pressed sap of fresh, flowering purple coneflower (38 -56:1) Capsule Short-term prevention and treatment of common cold. Dossier only
Eleutherococcus senticosus 50mg ethanolic dry extract of Siberian ginseng root (13-25:1) Capsule Symptoms of asthenia such as fatigue and weakness. Dossier only
Foeniculum vulgare 200mg essential oil Capsule Expectorant in cough associated with cold. Dossier only
Ginkgo biloba 40mg/120mg/40ml dry extract of Ginkgo leaves (35-67:1), Tablet/Solution Relief of symptoms of Raynaud's syndrome and tinnitus. In progress
Hamamelis virginiana Ethanolic fluid extract of Hamamelis leaves (1:1) Gel Relief of minor skin inflammation and dryness of the skin; hemorrhoids. Dossier only
Hedera helix 26mg/0,871g ethanolic dry extract of ivy leaves (6-7:1) Gum/Solution Common cold infections affecting the respiratory tract. In preparation
Hypericum perforatum 600mg ethanolic dry extract of St John's wort herb (3.5-6:1) Tablet Symptomatic treatment of anxiety, neuralgia, and nervous tension. In preparation
Illicium verum 100mg essential oil Capsule Symptomatic treatment of mild, spasmodic gastrointestinal complaints including bloating and flatulence; expectorant in cough associated with cold. Dossier only
Mentha piperita / Eucalyptus globulus / Rosmarinum officinale 100g contain 6.25g peppermint oil, 6.25g eucalyptus oil, 4.0g rosemary oil Cream Relief of rheumatic pains. In progress
Panax ginseng 100mg of ethanolic dry extract of ginseng root (3-4:1) Capsule Symptoms of asthenia such as fatigue and weakness. Dossier only
Pelargonium sidoides 100g contain ethanolic extract from Pelargonium roots 80g Solution Supportive treatment of respiratory tract infections, e.g., bronchitis and sinusitis. In preparation
Saccharomyces boulardii 250mg baker's yeast Capsule Prevention and symptomatic treatment of diarrhea; adjuvant treatment of acne. In preparation
Serenoa repens 320mg/160mg ethanolic extract of saw palmetto fruits (9-11:1) Capsule Treatment of micturition disorders in benign prostate hyperplasia, e.g., frequent urgency and nightly urgency. In preparation
Silybum marianum 50mg aceton dry extract of milk thistle fruits (26-45:1) Capsule Symptomatic relief of disorders of the liver and gall bladder. Dossier only
Solidago virgaurea 360mg ethanolic dry extract of goldenrod herb (5-7:1) Capsule Irrigation of the urinary tract, especially in cases of inflammation and renal gravel, and as adjuvant in treatment of bacterial infections of the urinary tract. Dossier only
Thymus vulgaris 75mg ethanolic dry extract (6-10:1) Gum/Pastille Expectorant in cough associated with cold. Dossier only
Valeriana officinalis 441.3mg ethanolic dry extract of valerian root (3-6:1) Tablet Relief of mild nervous tension and sleep disorders. In preparation
Valeriana officinalis / Melissa officinalis / Humulus lupulus 75mg valerian extract, 23mg hop strobile extract, 45mg lemon balm leaf extract Tablet Overcome nervous restlessness and difficulties in falling asleep. In progress
Zingiber officinale 250mg powdered drug Capsule Relief of dyspeptic complaints and/or travel sickness. In progress