IRESSA Film-coated tablets Ref.[9032] Active ingredients: Gefitinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose (E460)
Croscarmellose sodium
Povidone (K29-32) (E1201)
Sodium laurilsulfate
Magnesium stearate

Tablet coating:

Hypromellose (E464)
Macrogol 300
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

AstraZeneca AB, SE-151 85, Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/09/526/001

EU/1/09/526/002

Date of first authorisation: 24/06/2009

Date of latest renewal: 23/04/2014

Drugs

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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