The clinical evaluator also recommended various revisions to the PI; details of these are beyond the scope of the AusPAR. V. Pharmacovigilance findings Risk management plan The sponsor submitted an Australian RMP Version 1.0 dated March 2012 (data lock point 28 November 2011) which was reviewed by the TGA’s Office of Product Review (OPR). A summary of the RMP is shown in Table 7. Table 7. Summary of Risk Management Plan Safety Concern Proposed Proposed Risk Pharmacovigilance Minimisation Activities Activities (Routine and (Routine and Additional) Additional) Important identified risks Exacerbation of Routine Routine neutropenia Infusion-associated Routine Routine reactions Hypersensitivity/ Routine Routine Anaphylaxis Important potential risks Oligohydramnios Routine Routine Interstitial lung disease Routine None (ILD) Important missing information Patients with hepatic Routine Routine impairment Patients with renal Routine Routine impairment Patients with Routine Routine cardiovascular impairment Male patients Routine None Pregnant women Routine Routine
The clinical evaluator also recommended various revisions to the PI; details of these are beyond the scope of the AusPAR. V. Pharmacovigilance findings Risk management plan The sponsor submitted an Australian RMP Version 1.0 dated March 2012 (data lock point 28 November 2011) which was reviewed by the TGA’s Office of Product Review (OPR). A summary of the RMP is shown in Table 7. Table 7. Summary of Risk Management Plan Safety Concern Proposed Pharmacovigilance Activities (Routine and Additional) Proposed Risk Minimisation Activities (Routine and Additional) Important identified risks Exacerbation of neutropenia Routine Routine Infusion-associated reactions Routine Routine Hypersensitivity/ Anaphylaxis Routine Routine Important potential risks Oligohydramnios Routine Routine Interstitial lung disease (ILD) Routine None Important missing information Patients with hepatic impairment Routine Routine Patients with renal impairment Routine Routine Patients with cardiovascular impairment Routine Routine Male patients Routine None Pregnant women Routine Routine
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