V. Pharmacovigilance findings Risk management plan The sponsor submitted a Risk Management Plan which was reviewed by the TGA’s Office of Product Review (OPR). The following table (Table 27) summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the second round OPR evaluation of the sponsor’s responses.
V. Pharmacovigilance findings Risk management plan The sponsor submitted a Risk Management Plan which was reviewed by the TGA’s Office of Product Review (OPR). The following table (Table 27) summarises the OPR’s evaluation of the RMP, the sponsor’s responses to issues raised by the OPR and the second round OPR evaluation of the sponsor’s responses.
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