However, healthcare providers are not required to limit prescriptions or recommendations to the indications approved by their country's drug regulatory agency, and in fact the standard of care for many conditions involves off-label uses, either as first-line therapy or as a subsequent line. Drug manufacturers are not legally permitted to encourage the use of regulated drugs for any indications that have not been formally approved by the country's government, even if significant scientific evidence exists for that unapproved indication, or if another country's drug agency has approved that indication. All legally approved indications are listed on the drug package insert or 'label'.

When the drug's manufacturer has received a marketing authorisation from the government agency, then it is allowed to promote the drug for the specific, agreed-upon approved indications in that country. For example, aspirin is generally indicated for a headache, but it is not indicated for headaches in people with an allergic reaction to it. Indications may depend not only upon the medical condition that is being treated, but also upon other factors, such as dose, the patient's age, size and sex, whether the patient is pregnant or breastfeeding, and other medical conditions. ( March 2020) ( Learn how and when to remove this template message)Īn indication is when a drug is medically appropriate for a given condition an approved indication is when a government drug regulatory agency formally agrees that the drug is medically appropriate for the named condition. Unsourced material may be challenged and removed. Please help improve this section by adding citations to reliable sources.

Take as needed for pain medical label