---

Benzodiazepines

Answer

At the time of licensing Ativan (original brand name for lorazepam), the Medicines and Healthcare products Regulatory Agency's predecessor, the Medicines Division of the Department of Health and Social Security, considered that the data provided were sufficient, in terms of the evidence of quality, safety and efficacy, to allow the grant of a marketing authorisation. The Committee on the Review of Medicines also considered the risk:benefit balance of Ativan to be positive in relation to quality, safety and efficacy.The licences for all oral Ativan products were cancelled in 2008 at the request of the marketing authorisation holder for commercial reasons and the Department no longer holds the original clinical trial data which supported these applications.A number of generic lorazepam products have been approved in the United Kingdom following a thorough assessment of the data submitted by the applicant companies. However, under the terms of the Directive 2001/83/EC (article 10.1 'generic application' or article 10c 'informed consent') the product information for the new generic must reflect the safety information contained within the brand leader's product information and these applications do not need to be supported by new clinical trials investigating safety.The Medicines and Healthcare products Regulatory Agency continuously monitors the safety of medicines using a variety of sources including information from clinical studies, published literature, spontaneous case reports, data from marketing authorisation holders as well as other regulatory authorities. This information is used to ensure that up to date information is provided in the product information, which consists of the Summary of Product Characteristics (SPC) and Patient Information Leaflet, to aid the safe use of the medicine for the approved indication.

Secondary information

Type

Written question

Reference

518 c136W; 21751

Session

2010-12

Related items

Benzodiazepines
Friday, 3 December 2010
Written questions
House of Commons

Subjects

Benzodiazepines

Link

View this Written question on www.publications.parliament.uk