Anoro Ellipta Adverse Reactions

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Full Prescribing Info

Adverse Reactions

Clinical trial data: The safety profile of ANORO ELLIPTA is based on approximately 3,000 patients with COPD who received doses of umeclidinium/vilanterol 62.5/25 micrograms or greater for up to one year during clinical studies. This includes approximately 1,600 patients who received 62.5/25 micrograms and approximately 1,300 patients who received 125/25 micrograms, both once daily.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000). (See Table 3.)

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Reporting of suspected adverse reaction: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Anoro Ellipta Adverse Reactions

umeclidinium + vilanterol

Manufacturer:

GlaxoSmithKline Indonesia