Kaloba Monograph

 

Download the Kaloba Monograph PDF (6.19MB)

The Kaloba Monograph is a technical booklet containing technical product specifications including research evidence for healthcare professionals.

The Medicines and Healthcare Products Regulatory Agency (MHRA) granted Dr Willmar Schwabe & Co. KG a Traditional Herbal Registration Certificate for the traditional herbal medicinal product Kaloba® (EPs7630) Oral Solution (Traditional Herbal Registration Number THR 05332/0003) on 26th March 2008. This product is available without a prescription and can be bought from pharmacies and other outlets.

Further registration approvals for the Kaloba®(EPs7630) range, all containing the Pelargonium extract EPs®®7630, have been obtained. Kaloba® (EPs7630) film-coated tablets received approval on 31st March 2009, and Kaloba® (EPs7630) syrup on 11th June 2010.

The active ingredient of the product Kaloba® (EPs7630) comes from the roots of the plant Pelargonium sidoides DC (Pelargonium). Kaloba® (EPs7630) is a traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including the common cold, such as sore throat, cough and blocked or runny nose, based on traditional use only.

This registration is based exclusively upon longstanding use of the extract from the roots of the plant and not upon data generated from clinical trials. This is because there is no requirement under the Traditional Herbal Registration Scheme to prove scientifically that the product works.

However, there is a large body of published clinical and pre-clinical evidence relating to Pelargonium sidoides DC (Pelargonium) that forms the basis of this monograph, which should be read in conjunction with the current Summary of Product Characteristics. Most of the available published clinical trials have been conducted with Kaloba® (EPs7630) extract.

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