bronchospasm occurs and alternative therapy instituted if necessary.” Consequently it is suggested that ‘Paradoxical bronchospasm’ should be included as an important potential risk. The SS of the EU-RMP The sponsor has This is acceptable refers to provided a justification and it is noted that ‘Hypokalaemia’, & based on clinical data this appears to ‘Hyperglycaemia’ as important to support the have been ‘Tremor’ pharmacological class omission of accepted by the effects for LABA and EMA. ‘Hypokalaemia’, routine pharmacovigilance or ‘Hyperglycaemia’ activities will monitor these as important ‘Tremor’ effects. Consequently it is potential risks in the suggested that EU-RMP. ‘Hypokalaemia’, & ‘Hyperglycaemia’ should be ‘Tremor’ included as important potential risks. The SS of the EU-RMP The sponsor has This is acceptable refers to provided a justification and it is noted that ‘Gastrointestinal obstruction’ as an based on clinical data this appears to important pharmacological to support the have been class effect for LAMA and omission of accepted by the routine pharmacovigilance EMA. ‘Gastrointestinal activities will monitor this obstruction’ as an effect. Consequently it is important potential suggested that risk in the EU-RMP. ‘Gastrointestinal obstruction’ should be included as important potential risk. The draft PI states: in subjects with This is acceptable. “Anoro ‘Safety Ellipta has not been studied severe hepatic in patients with severe impairment’ has been hepatic impairment (see PKs included as missing Special Patient information in the – Populations).” Consequently updated UMEC/VI it is suggested that in ‘Use patients with severe hepatic impairment’ should be included as important missing information.
bronchospasm occurs and alternative therapy instituted if necessary.” Consequently it is suggested that ‘Paradoxical bronchospasm’ should be included as an important potential risk. The SS of the EU-RMP refers to ‘Hypokalaemia’, ‘Hyperglycaemia’ & ‘Tremor’ as important pharmacological class effects for LABA and routine pharmacovigilance activities will monitor these effects. Consequently it is suggested that ‘Hypokalaemia’, ‘Hyperglycaemia’ & ‘Tremor’ should be included as important potential risks. The sponsor has provided a justification based on clinical data to support the omission of ‘Hypokalaemia’, ‘Hyperglycaemia’ or ‘Tremor’ as important potential risks in the EU-RMP. This is acceptable and it is noted that this appears to have been accepted by the EMA. The SS of the EU-RMP refers to ‘Gastrointestinal obstruction’ as an important pharmacological class effect for LAMA and routine pharmacovigilance activities will monitor this effect. Consequently it is suggested that ‘Gastrointestinal obstruction’ should be included as important potential risk. The sponsor has provided a justification based on clinical data to support the omission of ‘Gastrointestinal obstruction’ as an important potential risk in the EU-RMP. This is acceptable and it is noted that this appears to have been accepted by the EMA. The draft PI states: “Anoro Ellipta has not been studied in patients with severe hepatic impairment (see PKs – Special Patient Populations).” Consequently it is suggested that ‘Use in patients with severe hepatic impairment’ should be included as important missing information. ‘Safety in subjects with severe hepatic impairment’ has been included as missing information in the updated UMEC/VI This is acceptable.
auspar-umeclidinium-bromide-and-vilanterol_trifenatate-150408.docx