Medication leaflets

Search for medicines for human use

Index of medicines for human use

letter I · page 17

927

WHO (World Health Organization): Any substance or product that is used or is intended to be used to alter a physiological system or a pathological condition in the recipient's benefit.

EMA (European Medicines Agency): any substance or combination of substances:
1 . Presented as having properties to treat or prevent disease in humans or animals.
2 . Which can be administered to humans to restore, correct or modify a physiological function by the exercise of a pharmaceutical, immunological or metabolic action, or to make a diagnosis.

Active ingredient: the substance used to make the medicine for the purpose producing a pharmaceutical, immunological or metabolic effect to restore, correct or modify a physiological function.

Excipients: Any substance used as an adjunct in the manufacture of the drug but which is pharmaceutically inert. Gives the drug chemical stability and helps the transfer of the active substance to the place where it is to reach its place of performance.

Original drug: The product that has been authorized worldwide to be sold, as a patented product based on documentation on efficacy, safety and quality, in in accordance with the requirements at the time of authorization is the original medicinal product or the medicinal product reference. When the product is marketed under a brand protected name it becomes a brand name drug.

Generic drug: is designed to be the same as the original after it the patent expires. They contain the same active substance as the original product, being equivalent to in terms of dose, concentration, route of administration, safety, efficacy and therapeutic indications.