Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
IRESSA 250 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets (tablet). Tablets are brown, round, biconvex, impressed with “IRESSA 250” on one side and plain on the other. |
Each tablet contains 250 mg of gefitinib.
Excipients with known effect:
Each tablet contains 163.5 mg of lactose (as monohydrate).
Each tablet contains 3.86 mg of sodium.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Gefitinib |
Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy. No clinically relevant activity has been shown in patients with known EGFR mutation-negative tumours. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Hypromellose (E464) |
PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Three blisters are combined with an aluminium foil laminate over-wrap in a carton.
Pack size of 30 film-coated tablets. Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85, Södertälje, Sweden
EU/1/09/526/001
EU/1/09/526/002
Date of first authorisation: 24/06/2009
Date of latest renewal: 23/04/2014
| Drug | Countries | |
|---|---|---|
| IRESSA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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