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Herbal medicinal product: Malvae sylvestris flosArray, F: Assessment finalised

The HMPC conclusions on the use of these mallow flower medicines for the mouth or throat irritation and associated dry cough, and mild stomach and gut discomfort 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 considered studies in laboratory tests showing cough reduction and anti-inflammatory effects of mallow flower preparations. The HMPC noted the lack of studies with mallow flower in patients. For detailed information on the studies assessed by the HMPC, see the HMPC assessment report under the section ‘Documents’ on the Agency’s website: ema.europa.eu/medicines/herbal/malvae-sylvestris-flos.

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