Use of contraception outside the terms of the product licence

10.1136/dtb.18.15.60 ◽

1980 ◽

Vol 18 (15) ◽

pp. 60-60

Keyword(s):

Data Sheet ◽

The Product Licence Number given at the end of every data sheet is more useful than is generally recognised. It says something important about the drug and about the value of its data sheet, because it indicates whether the product has been fully assessed by the Licensing Authority and the Committee on Safety of Medicines or whether it merely has a “Licence of Right” (PLR), issued because it was already on the market when the CSM began to issue licences in 1971.

computer assisted product licence application

Dictionary of Pharmaceutical Medicine ◽

10.1007/978-3-211-89836-9_261 ◽

2009 ◽

pp. 35-35

Author(s):

Gerhard Nahler

Keyword(s):

Computer Assisted ◽

Prescribing of unlicensed medicines or licensed medicines for unlicensed applications in child and adolescent psychiatry

Psychiatric Bulletin ◽

10.1192/pb.25.12.465 ◽

2001 ◽

Vol 25 (12) ◽

pp. 465-466 ◽

Cited By ~ 8

Author(s):

Joanne Johnson ◽

Andrew F. Clark

Keyword(s):

Mental Health ◽

Mental Health Services ◽

Health Services ◽

Child And Adolescent ◽

Child And Adolescent Psychiatry ◽

Health Practice ◽

North West ◽

Child Mental Health Services ◽

Paediatric Practice ◽

Aims and MethodChild and adolescent mental health services in north-west England (n=21) participated in a prospective collection of information regarding all instances of new prescribing of medication over the 6–month period September 1999 to February 2000.ResultsA total of 478 new prescriptions were issued to 411 individuals. Eight prescriptions (2%) were for an unlicensed drug and a further 188 (39%) were of licensed drugs but used in a manner outside of their product licence.Clinical ImplicationsThis level of unlicensed and outside-licence prescribing is similar to levels previously found in studies both within paediatric practice and in adult mental health practice. Anxiety about excessive beyond-licence prescribing by child mental health services is unlikely to be justified.

Oxyphenbutazone eye ointment

10.1136/dtb.22.22.88 ◽

1984 ◽

Vol 22 (22) ◽

pp. 88-88

Keyword(s):

Bone Marrow ◽

Bone Marrow Toxicity ◽

We have previously considered oxyphenbutazone eye ointment (Tanderil Eye Ointment).1,2 Recently, the Licensing Authority has withdrawn the product licence for oral oxyphenbutazone because of its bone marrow toxicity.3 Oxyphenbutazone eye ointment is used for treating episcleritis: should its licence also be withdrawn?

A ‘Suntan’ in capsules - orobronze

10.1136/dtb.21.15.57 ◽

1983 ◽

Vol 21 (15) ◽

pp. 57-57 ◽

Cited By ~ 2

Keyword(s):

Vitamin A ◽

Medicinal Product ◽

Food Additive ◽

Over The Counter ◽

Farmed Salmon ◽

Naturally Occurring ◽

Brown Colour ◽

Healthy Activity ◽

To some people a suntan is an indicator of healthy activity and social prowess. Canthaxanthin is a naturally occurring orange carotenoid without vitamin A properties made by Hoffmann-La Roche and used, for example, as a food additive to improve the colour of farmed salmon. It is now also available over the counter as 30 mg oral capsules (Orobronze - De Witt) for people to dye themselves an orange-brown colour. The DHSS has not issued a product licence for Orobronze because it is ‘not a medicinal product’.

▾ Cisapride – more selective than metoclopramide

10.1136/dtb.28.23.89 ◽

1990 ◽

Vol 28 (23) ◽

pp. 89-90

Keyword(s):

Gastric Emptying ◽

Gastrointestinal Motility ◽

Chemical Structure ◽

Sphincter Pressure ◽

Antiemetic Effect ◽

Gut Motility ◽

Prokinetic Drugs ◽

Similar Chemical ◽

Non Ulcer Dyspepsia ◽

Metoclopramide (Maxolon; Primperan), has been around for over 20 years and domperidone (Motilium - Sterling Winthrop) for eight years. Both are prokinetic drugs which speed gastric emptying, increase oesophageal sphincter pressure, stimulate gut motility and in addition have a central antiemetic effect. Cisapride (Prepulsid - Janssen; Alimix - Cilag) has a similar chemical structure to metoclopramide and is intended for the reduction of oesophageal reflux and relief of symptoms caused by impaired gastrointestinal motility. The product licence has recently been extended to include treatment of non-ulcer dyspepsia.

The use of in vitro methods for studying drug metabolism to replace animal studies as part of veterinary medicines product licence applications

Toxicology in Vitro ◽

10.1016/0887-2333(94)90099-x ◽

1994 ◽

Vol 8 (4) ◽

pp. 917-919 ◽

Cited By ~ 1

Author(s):

I.C. Shaw

Keyword(s):

Drug Metabolism ◽

Animal Studies ◽

In Vitro Methods ◽

Veterinary Medicines ◽

Response of autumn calving suckler cows to the feed additive Avotan

Proceedings of the British Society of Animal Production (1972) ◽

10.1017/s030822960002643x ◽

1994 ◽

Vol 1994 ◽

pp. 96-96

Author(s):

B G Lowman ◽

N A Scott ◽

A J Mudd

Keyword(s):

Beef Cattle ◽

Dairy Cows ◽

Feed Efficiency ◽

Beef Cows ◽

Milk Composition ◽

Feed Additive ◽

Glycopeptide Antibiotic ◽

Gram Positive Bacteria ◽

Cattle Systems ◽

Avotan is a feed additive commonly used in finishing and growing beef cattle systems to improve feed efficiency - producing higher liveweight gains on similar feed intakes. The active ingredient is a glycopeptide antibiotic (Avoparcin, Cyanamid UK) active against Gram - positive bacteria. In 1991 Avotan received an EEC product licence for use in dairy cows. Extensive trials showed that on average Avotan gave a 5% response in milk yield on the same level of feed intake with no effect on milk composition. No information was however available on the use of Avotan in beef cows. This trial reports on the response of autumn calving suckler cows to Avotan in terms of both cow and calf liveweight change and cow fertility.

Product licence applications: Authors' reply

BMJ ◽

10.1136/bmj.302.6778.729-b ◽

1991 ◽

Vol 302 (6778) ◽

pp. 729-729

Author(s):

M D Rawlins ◽

D B Jefferys

Keyword(s):

Dressings for leg ulcers

10.1136/dtb.24.3.9 ◽

1986 ◽

Vol 24 (3) ◽

pp. 9-12

Keyword(s):

Clinical Trials ◽

General Practice ◽

Leg Ulcers ◽

Controlled Clinical Trials ◽

Skin Ulcers ◽

Many topical preparations and dressings are claimed to help skin ulcers to heal. Non-medicated dressings are not considered to be medicines and so do not need a product licence or proof of clinical efficacy. Many have not been assessed in well controlled clinical trials. Nevertheless, some of them are listed in the Drug Tariff and so can be prescribed in general practice. This article attempts to guide prescribers and nurses through the jungle of products advocated for treating leg ulcers.