Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa
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Date
2017
Authors
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Journal ISSN
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Publisher
University of the Western Cape
Abstract
Availability of clinically relevant and unbiased medicine information goes a long way in
promoting rational use of medicines. The package insert (PI) is one of the sources of
information utilised by healthcare professionals for accessing relevant medicine
information such as indications, contra-indications and special precautions (Singh,
Mohan, Kumar, & Gupta,2016). It is important that the PI contains updated safety
information. The safety information in the PIs of the innovator and generic medicines are
expected to be the similar since they contain the same active ingredients. Generic
medicines have the same efficacy and safety as innovator medicines and are considered
bioequivalent. Generic medicines are interchangeable with innovator medicines.
Description
Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)