these trials are no longer considered for inclusion as additional pharmacovigilance activities in EU-RMP version 11 and were removed accordingly.’ 4. The studies The sponsor states: This is acceptable. ‘A referenced in the summary of forthcoming pharmacovigilance plan studies and anticipated will generate safety dates for submission to data that will simply the TGA is provided in support the known the Stelara ASA, Sections safety profile of the 7 and 8. This tabular medicine, while others summary of the studies will generate data that has previously been will provoke included in the EU RMP applications to amend and is now being the Australian updated and added to registration details. To the ASA. Note there are this end it is suggested no ongoing studies in that the sponsor should adults for the psoriasis provide an attachment or PsA indications.’ to the ASA setting out all the forthcoming studies and the anticipated dates for their submission in Australia. 5. The proposed The sponsor states: Section 6 of the updated ‘The Australian risk Stelara ASA has been ASA only details the risk minimisation activities amended to incorporate minimisation activities are similar to what was the recommendation and is not inclusive of previously accepted for (Stelara ASA, Section 6).’ pharmacovigilance Stelara. At this time activities. It is they continue to be recommended that the acceptable. sponsor maintain this Nevertheless the section of the ASA and sponsor should provide also include a table a summarising the summarising the pharmacovigilance plan pharmacovigilance and and risk minimisation risk minimisation plan proposed for activities for all of the Australia in the ASA. specified ongoing safety Wording pertaining to concerns and missing all the specified ongoing information proposed safety concerns in the for Australia in a proposed Australian PI revised ASA, which and Consumer Medicine should be submitted for Information (CMI) review before this should be included in application is approved. the table.
these trials are no longer considered for inclusion as additional pharmacovigilance activities in EU-RMP version 11 and were removed accordingly.’ 4. 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 their submission in Australia. The sponsor states: ‘A summary of forthcoming studies and anticipated dates for submission to the TGA is provided in the Stelara ASA, Sections 7 and 8. This tabular summary of the studies has previously been included in the EU RMP and is now being updated and added to the ASA. Note there are no ongoing studies in adults for the psoriasis or PsA indications.’ This is acceptable. 5. The proposed Australian risk minimisation activities are similar to what was previously accepted for Stelara. At this time they continue to be acceptable. Nevertheless the sponsor should provide a summarising the pharmacovigilance plan and risk minimisation plan proposed for Australia in the ASA. Wording pertaining to all the specified ongoing safety concerns in the proposed Australian PI and Consumer Medicine Information (CMI) should be included in the table. The sponsor states: ‘The Stelara ASA has been amended to incorporate the recommendation (Stelara ASA, Section 6).’ Section 6 of the updated ASA only details the risk minimisation activities and is not inclusive of pharmacovigilance activities. It is recommended that the sponsor maintain this section of the ASA and also include a table summarising the pharmacovigilance and risk minimisation activities for all of the specified ongoing safety concerns and missing information proposed for Australia in a revised ASA, which should be submitted for review before this application is approved.