Professional’ letter in has been included in the revised draft PI Australia regarding the provided with this response. risk of necrotizing fasciitis. This letter states changes to the product information regarding this risk. The proposed PI submitted with the current application however does not contain this statement. The sponsor should update the proposed PI accordingly. In regard to the Roche acknowledge that the draft consumer This is acceptable. medicine information be revised to reflect any proposed routine risk changes made to the proposed Australian PI. minimisation activities, it is recommended to the Delegate that the draft consumer medicine information document be revised to reflect any changes made to the proposed Australian PI. In regards to the ASA: ASA Version 4.0, November 2013, has been This is acceptable. revised to comply with the standard format a) It is recommended specified in the TGA RMP Q&A’s. ASA that the ASA be revised Version 4.0 will be submitted to TGA on 7 to comply with the November 2013. standard format specified in the TGA RMP Q&A’s. 9. b) The studies Roche acknowledge the recommendation. This referenced in the Following assessment of the data generated recommendation pharmacovigilance from studies referenced in the refers to the ASA and plan will generate pharmacovigilance plan, the company Core not to the Core Data safety data that will Data Sheet and Australian PI will be revised or the simply support the accordingly. Australian PI. known safety profile of To clarify, It is the medicine, while recommended that others will generate the next update of data that will provoke the ASA contain a applications to amend table stating all the Australian ongoing and planned registration details. To studies with this end, it is milestones and the suggested that the anticipated dates for sponsor should their submission in provide an attachment Australia. to the ASA setting out all the forthcoming studies and the anticipated dates for
Professional’ letter in Australia regarding the risk of necrotizing fasciitis. This letter states changes to the product information regarding this risk. The proposed PI submitted with the current application however does not contain this statement. The sponsor should update the proposed PI accordingly. has been included in the revised draft PI provided with this response. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft consumer medicine information document be revised to reflect any changes made to the proposed Australian PI. Roche acknowledge that the draft consumer medicine information be revised to reflect any changes made to the proposed Australian PI. This is acceptable. In regards to the ASA: a) It is recommended that the ASA be revised to comply with the standard format specified in the TGA RMP Q&A’s. ASA Version 4.0, November 2013, has been revised to comply with the standard format specified in the TGA RMP Q&A’s. ASA Version 4.0 will be submitted to TGA on 7 November 2013. This is acceptable. 9. b) The studies referenced in the pharmacovigilance plan will generate safety data that will simply support the known safety profile of the medicine, while others will generate data that will provoke applications to amend the Australian registration details. To this end, it is suggested that the sponsor should provide an attachment to the ASA setting out all the forthcoming studies and the anticipated dates for Roche acknowledge the recommendation. Following assessment of the data generated from studies referenced in the pharmacovigilance plan, the company Core Data Sheet and Australian PI will be revised accordingly. This recommendation refers to the ASA and not to the Core Data or the Australian PI. To clarify, It is recommended that the next update of the ASA contain a table stating all ongoing and planned studies with milestones and the anticipated dates for their submission in Australia.
auspar-bevacizumab-141103.docx