Rosmarini aetheroleum - herbal medicinal product
Rosemary oil
Herbal productHumanHerbal
Overview
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of Rosemary oil. It summarises the Committee’s recommendations on the use of Rosemary oil.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing Rosemary oil. When a Member State authorises a medicine containing Rosemary oil, detailed instructions on how to take it will be available in the package leaflet that comes with medicine.
The information in this summary report concerns herbal medicinal products containing Rosemary oil which are only authorised when they comply with the strict pharmaceutical quality and other requirements for herbal medicinal products. They are approved by the competent authorities to be placed on the market as medicinal products. Other products, like food, food supplements, cosmetic products or medical devices do not follow the same criteria and regulatory requirements as medicinal products and are excluded from this summary.
Rosemary oil is the common name for the essential oil obtained from the above ground part of the plant Rosmarinus officinalis L.
Medicinal products with Rosemary oil contain the essential oil of the above-ground part of the plant, in semi-solid form to be applied to the skin.
Rosemary oil preparations have a traditional medicinal use for the relief of minor muscular and articular pain, and in minor disorders of circulatory blood flow in the legs. Traditional medicinal use means that the use in the specified indication is exclusively based upon long-standing medicinal use and not based on results from clinical studies.
You can find detailed instructions on how to take Rosemary oil medicines and who can use them in the package leaflet that comes with the medicine.
Do not use Rosemary oil:
- for children and adolescents under 18 year of age.
- if you are pregnant or breast feed your child.
- if you are allergic to the Rosemary plant.
- when you are known with heart or kidney diseases.
Do not apply around the eyes or the mucous membranes.
Consult a doctor:
- if there is inflammation of the skin with subcutaneous swelling, ulcers, sudden swelling of both legs together with redness and heat.
- if you suffer from a sudden sharp pain in the leg when at rest and stop the use of the medicinal product.
- if your symptoms worsen especially when articular pain together with swelling and/or redness of the joint, or fever occur.
Consult a doctor or a pharmacist if the symptoms persist or worsen longer than 4 weeks during the use of the medicinal product.
No interactions with other medicines have been described in the literature at the time of assessment when using Rosemary oil with other medicines.
You may experience some side effects with Rosemary oil medicines.
You may get hypersensitivity reactions like contact dermatitis or causing difficulty in breathing like asthma.
The frequency of these undesirable effects is not known.
The HMPC conclusions on the use of these Rosemary oil medicines for the relief of minor muscular and articular pain and in minor peripheral circulatory disorders are based on their ‘traditional use’.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the European Union.)
Any applications for the licensing of medicines containing Rosemary oil have to be submitted to the national authorities responsible for medicinal products. Before approval, the national authorities assess the quality, safety and efficacy of the herbal medicine. The HMPC conclusions are taken into account when evaluating applications for the licensing of herbal medicines.
Information on approved Rosemary oil medicines in EU Member States may be obtained from the relevant national authorities.
BG (bulgarski): Розмариново масло
CS (čeština): rozmarýnová silice
DA (dansk): Rosmarinolie
DE (Deutsch): Rosmarinöl
EL (elliniká): λιβανωτίδος (δενδρολιβάνου) αιθέριο έλαιο
EN (English): Rosemary oil
ES (español): romero, aceite esencial de
ET (eesti keel): rosmariiniõli
FI (suomi): rosmariiniöljy
FR (français): romarin (huile essentielle de)
HR (hrvatski): ružmarinovo eterično ulje
HU (magyar): rozmaringolaj
IT (italiano): Rosmarino essenza
LT (lietuvių kalba): Rozmarinų eterinis aliejus
LV (latviešu valoda): Rozmarīna ēteriskā eļļa
MT (Malti): żejt tal-klin
NL (Nederlands): Rozemarijnolie
PL (polski): Olejek eteryczny rozmarynowy
PT (português): óleo essencial de alecrim
RO (română): ulei volatil de rosmarin
SK (slovenčina): silica rozmarínu
SL (slovenščina): eterično olje navadnega rožmarina
SV (svenska): rosmarinolja
NO (norsk): rosmarinolje
Key facts
- Latin name
- Rosmarini aetheroleum
- English common name
- Rosemary oil
- Botanical name
Rosmarinus officinalis L.
- Therapeutic area
- Circulatory disorders
- Gastrointestinal disorders
- Status
- F: Assessment finalised
- Date added to the inventory
- Date added to priority list
- Outcome of European assessment
- European Union herbal monograph