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Herbal medicinal product: Rosae flosArray,Array,Array, F: Assessment finalised

The HMPC conclusions on the use of these rose flower medicines for mild mouth, throat and skin inflammation 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 EU). Moreover, the intended use does not require medical supervision.

In its assessment, the HMPC also considered a clinical study involving 50 patients with inflammation of the lining of the mouth, where rose flower mouthwash was compared with placebo (a dummy treatment). Results showed that rose flower mouthwash was more effective than placebo in treating mouth inflammation. However, since the study was small, the HMPC conclusions on the use of these rose flower medicines are mainly based on their long-standing use.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

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