The draft PI states: a in long term This is acceptable. “In ‘Safety long-term safety study, 335 use’ has been included subjects were treated for up as missing information to 12 months with Anoro in the updated Ellipta 125/25 µg or UMEC/VI EU-RMP. placebo.” Consequently it is suggested that ‘Long-term safety data’ should be included as important missing information. If the sponsor decides to The EU-RMP has been This is acceptable. include ongoing safety updated to reflect the concerns in Australia for inclusion of Anoro Ellipta then ‘paradoxical consideration must be bronchospasm’, given as to what ‘narrow pharmacovigilance and risk glaucoma’ and ‘bladder minimisation activities will outflow obstruction be proposed for them and and urinary retention’ the ASA should be revised as important potential accordingly. risks. Additionally, missing information has been updated to include in ‘safety use’ and in ‘safety severe hepatic impairment’. The Summary of the Safety Concerns (Part II Module SVIII) has been updated accordingly. The proposed pharmacovigilance activities, including any risk minimisation measures have been updated in the pharmacovigilance plan to reflect the inclusion of these additional safety concerns. The ASA has been revised accordingly. It is suggested the The sponsor will This is acceptable. important potential risk: include the term related intubations to the ‘Asthma ‘hospitalisation’ and death’ be revised to important potential related risk of related ‘Asthma ‘Asthma intubations, hospitalisation intubations and death’
The draft PI states: “In a long-term safety study, 335 subjects were treated for up to 12 months with Anoro Ellipta 125/25 µg or placebo.” Consequently it is suggested that ‘Long-term safety data’ should be included as important missing information. ‘Safety in long term use’ has been included as missing information in the updated UMEC/VI EU-RMP. This is acceptable. If the sponsor decides to include ongoing safety concerns in Australia for Anoro Ellipta then consideration must be given as to what pharmacovigilance and risk minimisation activities will be proposed for them and the ASA should be revised accordingly. The EU-RMP has been updated to reflect the inclusion of ‘paradoxical bronchospasm’, ‘narrow glaucoma’ and ‘bladder outflow obstruction and urinary retention’ as important potential risks. Additionally, missing information has been updated to include ‘safety in use’ and ‘safety in severe hepatic impairment’. The Summary of the Safety Concerns (Part II Module SVIII) has been updated accordingly. The proposed pharmacovigilance activities, including any risk minimisation measures have been updated in the pharmacovigilance plan to reflect the inclusion of these additional safety concerns. The ASA has been revised accordingly. This is acceptable. It is suggested the important potential risk: ‘Asthma related intubations and death’ be revised to ‘Asthma related intubations, hospitalisation The sponsor will include the term ‘hospitalisation’ to the important potential risk of ‘Asthma related intubations and death’ This is acceptable.