---

Benzodiazepines

Answer

Drug misuse and dependence UK guidelines on clinical management produced by the four UK health departments provides guidance on the treatment of withdrawal from Benzodiazepines. These guidelines do not refer to a maximum period for withdrawal. They advise that a reduction in dose (converted to an appropriate dose of diazepam) is tapered over time with regular assessments to determine the most effective rate of this reduction based on the individual clinical needs of the patient.A list of granted marketing authorisations for generic Lorazepam is provided in the following table. The name of the marketing authorisation holder and the product name are provided in each case. The table also indicates the legislative provision under which each generic licence was authorised where this has been established from available records.At the time these Marketing Authorisations were granted the extant directive on medicinal products was Directive 65/65/EC. Applications for generic products would have been made under Article 4.8a which made provision for an abridged application, that is, an application made without supplying results of toxicological tests and clinical trials.An abridged application was permitted if either (i) the holder of an existing authorisation gave consent for his clinical and toxicological data to be cross-referenced or (ii) the product had well established use with recognized efficacy and an acceptable level of safety or (iii) the medicinal product was essentially similar to a product which had been authorized on the basis of full data on safety and efficacy including clinical trials. It was Article 4.8a(iii) that was most commonly used at that time for generic applications.The MHRA is not legally required to retain any data it receives as part of an application. Under MHRA record management policy all application files (files that are submitted by a manufacturer for the licensing of a product) and data for licences are held for 15 years. Clinical trial files are held for five years. From September 2010, the MHRA has only kept other data subject to ongoing business.The MHRA continuously monitors the safety of all medicines in the UK 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. In doing this, the MHRA does not rely on the safety information in the original application file, especially when the application is not recent.

Authorisation number	Authorisation holder company name	Authorisation date	Licensed product name	Legislative basis
PL 00530/0080	Norton Healthcare Limited	1 April 1981	Lorazepam Tablets B.P. 1MG	Not confirmed
PL 00530/0081	Norton Healthcare Limited	1 April 1981	Lorazepam Tablets B.P. 2.5MG	Not confirmed
PL 00142/0164	Actavis UK Limited	18 November 1982	Lorazepam Tablets BP 1MG	Not confirmed
PL 00142/0165	Actavis UK Limited	18 November 1982	Lorazepam Tablets BP 2.5 MG	Not confirmed
PL 04569/0024	Generics (UK) Limited	8 December 1982	Lorazepam Tablets BP 1 MG	Not confirmed
PL 04569/0025	Generics (UK) Limited	8 December 1982	Lorazepam Tablets 2.5MG	Not confirmed
PL 00225/0063	DDSA Pharmaceuticals Limited	4 February 1985	Lorazium Tablets 1MG	Not confirmed
PL 00225/0075	DDSA Pharmaceuticals Limited	18 October 1985	Lorazium Tablets 2.5MG	Abridged Application
PL 04556/0019	Pharmvit Limited	8 January 1986	Lorazepam Tablets 1MG	Not confirmed
PL 04556/0020	Pharmvit Limited	8 January 1986	Lorazepam Tablets 2.5MG	Not confirmed
PL 04416/0016	Sandoz Limited	11 January 1987	Sedazin Tablets 1MG	Cross Referred to PL 00530/0080
PL 04416/0017	Sandoz Limited	11 January 1987	Sedazin Tablets 2.5MG	Cross Referred to PL 00530/0081
PL 04416/0094	Sandoz Limited	23 March 1987	Lorazepam 1 MG. Tablets	Abridged Application
PL 04416/0095	Sandoz Limited	23 March 1987	Lorazepam Tablets 2.5MG	Abridged Application
PL 00095/0126	Cyanamid of Great Britain Limited	6 March 1991	Lorazepam Tablets 1MG	Not confirmed
PL 00095/0127	Cyanamid of Great Britain Limited	6 March 1991	Lorazepam Tablets 2.5MG	Not confirmed
PL 00401/0050	M A Steinhard Limited	22 March 1991	Almazine Lorazepam Tablets 1MG	Not confirmed
PL 00401/0051	M A Steinhard Limited	22 March 1991	Almazine Lorazepam Tablets	Not confirmed
PL 00039/0182	UCB Pharma Limited	11 July 1991	Tablets Lorazepam 1MG	Not confirmed
PL 00152/0224	BERK Pharmaceuticals Limited	11 July 1991	Lorazepam Tablets 1MG	Cross Referred to PL 00530/0080
PL 00152/0225	BERK Pharmaceuticals Limited	11 July 1991	Lorazepam Tablets 2.5MG	Cross Referred to PL 00530/0081
PL 00037/0180	Abbott Laboratories Limited	11 July 1991	Lorazepam 1MG Tablets BP	Not confirmed
PL 00037/0181	Abbott Laboratories Limited	15 September 1991	Lorazepam 2.5MG Tablets BP	Not confirmed
PL 00039/0183	UCB Pharma Limited	31 March 1992	Tablets Lorazepam 2.5MG	Not confirmed
PL 04077/0124	M and A Pharmachem Limited	23 August 1993	Lorazepam Tablets 1MG.	Abridged Application
PL 04077/0125	M and A Pharmachem Limited	23 August 1993	Lorazepam Tablets 2.5 MG	Abridged Application
PL 17521/0060	Metwest Pharmaceuticals Limited	19 July 2002	Lorazepam 1MG Tablets	Cross Referred to PL 00225/0063
PL 17521/0061	Metwest Pharmaceuticals Limited	19 July 2002	Lorazepam 2.5mg Tablets	Cross Referred to PL 00225/0075

Secondary information

Type

Written question

Reference

31749; 520 c1265-8W

Session

2010-12

Subjects

Drugs Misuse

Link

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