Health / Medical Topics |
Pharmaceutical Product Information
A document defining content and form of the information that has to be supplied with or about a pharmaceutical product by or on behalf of the marketing authorization holder. The minimum information in the product information is that defined by WHOs sample product information sheet. In international setting according to WHOs requirements, the content of the product information is agreed between the marketing authorization holder and the drug authorization authorities at the time the market authorization is issued. (NCI Thesaurus)
YOU MAY ALSO LIKE
As part of the CGMP regulations, the FDA requires that drug products bear an expiration date determined by appropriate stability testing (21…
The distinguishing qualities of a pharmaceutical product or substance.
A person who initiates and maintains a contact or connection pertaining to pharmacy.
The composition of a dosage form, including the characteristics of its raw materials and the operations required to process it.Formulation factors include…
Any intentionally added component of a finished pharmaceutical product other than the claimed therapeutic or diagnostic ingredient(s). The excipients are added to…
The form in which active and/or inert ingredient(s) are physically presented.