PDF《(THR 20894/0071)》

MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

1 Gerard House Max Strength Milk Thistle Tablets (THR 20894/0071) Gerard House Milk Thistle Tablets HERBALSTORE Milk Thistle Tablets Wilko Milk Thistle Tablets (THR 20894/0072) UKPAR TABLE OF CONTENTS Lay summary Page

2 Scientific discussion Page

3 Steps taken for assessment Page

12 Summaries of Product Characteristics Page

13 Product Information Leaflets Page

21 Labelling Page

25 MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

2 GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) GERARD HOUSE MILK THISTLE TABLETS HERBALSTORE MILK THISTLE TABLETS WILKO MILK THISTLE TABLETS (THR 20894/0072) LAY SUMMARY The Medicines and Healthcare products Regulatory Agency (MHRA) granted Brunel Healthcare Manufacturing Limited Traditional Herbal Registration Certificates for the traditional herbal medicinal products Gerard House Max Strength Milk Thistle Tablets (Traditional Herbal Registration number: THR 20894/0071) and Gerard House Milk Thistle Tablets, HERBALSTORE Milk Thistle Tablets and Wilko Milk Thistle Tablets (Traditional Herbal Registration number: THR 20894/0072) on

14 March 2012.

Gerard House Max Strength Milk Thistle Tablets will be referred to as Max Strength Milk Thistle Tablets in the remainder of this report. Gerard House Milk Thistle Tablets, HERBALSTORE Milk Thistle Tablets and Wilko Milk Thistle Tablets are identical to each other apart from the difference in product names and will be collectively referred to as Milk Thistle Tablets in the remainder of this report. These products are available without prescription and can be bought from pharmacies and other outlets. Max Strength Milk Thistle Tablets and Milk Thistle Tablets are traditional herbal medicinal products used to relieve the symptoms associated with occasional over indulgence of food and drink such as indigestion and upset stomach, based on traditional use only. The active ingredient of Max Strength Milk Thistle Tablets and Milk Thistle Tablets comes from the fruit of the Milk thistle plant (Silybum marianum (L.) Gaertner). These registrations are based exclusively upon the longstanding use of Milk thistle fruit as a traditional herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration Scheme to prove scientifically that a product works. No new or unexpected safety concerns arose from these applications and it was, therefore, decided that Traditional Herbal Registration Certificates could be granted. MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

3 GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) GERARD HOUSE MILK THISTLE TABLETS HERBALSTORE MILK THISTLE TABLETS WILKO MILK THISTLE TABLETS (THR 20894/0072) SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page

4 Pharmaceutical assessment Page

5 Non clinical assessment Page

8 Clinical assessment Page

9 Overall conclusions and risk assessment Page

11 MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)