Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
TAGRISSO 40 mg film-coated tablets.
TAGRISSO 80 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). TAGRISSO 40 mg tablets: Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse. TAGRISSO 80 mg tablets: Beige, 7.25 × 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse. |
TAGRISSO 40 mg tablets: Each tablet contains 40 mg osimertinib (as mesylate).
TAGRISSO 80 mg tablets: Each tablet contains 80 mg osimertinib (as mesylate).
TAGRISSO 40 mg tablets: Each tablet contains 0.3 mg sodium.
TAGRISSO 80 mg tablets: Each tablet contains 0.6 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Osimertinib |
Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of EGFRs harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M. In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant NSCLC cell lines. |
| List of Excipients |
|---|
|
Tablet core: Mannitol Tablet coating: Polyvinyl alcohol |
Al/Al perforated unit dose blisters. Cartons of 30 × 1 tablets (3 blisters).
Al/Al perforated unit dose blisters. Cartons of 28 × 1 tablets (4 blisters).
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/16/1086/001 40 mg 30 film-coated tablets
EU/1/16/1086/002 80 mg 30 film-coated tablets
EU/1/16/1086/003 40 mg 28 film-coated tablets
EU/1/16/1086/004 80 mg 28 film-coated tablets
Date of first authorisation: 2 February 2016
Date of latest renewal: 24 March 2022
| Drug | Countries | |
|---|---|---|
| TAGRISSO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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