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Pharmacovigilance
Pharmacovigilance describes the process of monitoring quality, safety, and efficacy of licensed drugs
Octapharma´s Drug Safety Unit has established a robust system to collect, collate, evaluate and report to the competent authorities, all information about suspected adverse reactions.
In addition, Octapharma publishes Periodic Safety Update Reports on all products, which include:
- all relevant new clinical & non-clinical safety data
- cumulative patient exposure data
- adverse reaction data
- summary of marketing authorisations / regulatory status
Octapharma also conducts a number of clinical pharmacovigilance / post-marketing studies to provide a comprehensive picture of clinical safety and efficacy.
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