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INLYTA (2013)

Active ingredients: Axitinib

Product Name and Form

Inlyta 1 mg film-coated tablets.

Inlyta 3 mg film-coated tablets.

Inlyta 5 mg film-coated tablets.

Inlyta 7 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

1 mg: Red oval film-coated tablet debossed with “Pfizer” on one side and “1 XNB” on the other.

3 mg: Red round film-coated tablet debossed with “Pfizer” on one side and “3 XNB” on the other.

5 mg: Red triangular film-coated tablet debossed with “Pfizer” on one side and “5 XNB” on the other.

7 mg: Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other.

Qualitative and Quantitative Composition

1 mg film-coated tablets: Each film-coated tablet contains 1 mg of axitinib.

3 mg film-coated tablets: Each film-coated tablet contains 3 mg of axitinib.

5 mg film-coated tablets: Each film-coated tablet contains 5 mg of axitinib.

7 mg film-coated tablets: Each film-coated tablet contains 7 mg of axitinib.

Excipients with known effect:

1 mg film-coated tablets: Each film-coated tablet contains 33.6 mg of lactose monohydrate.

3 mg film-coated tablets: Each film-coated tablet contains 35.3 mg of lactose monohydrate.

5 mg film-coated tablets: Each film-coated tablet contains 58.8 mg of lactose monohydrate

7 mg film-coated tablets: Each film-coated tablet contains 82.3 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Axitinib

Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3. These receptors are implicated in pathologic angiogenesis, tumour growth, and metastatic progression of cancer. Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.

List of excipients

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Tablet film-coating:

Hypromellose
Titanium dioxide (E171)
Lactose monohydrate
Triacetin (E1518)
Iron oxide red (E172)

Pack sizes and Marketing

1 mg, 3 mg, 5 mg, 7 mg film-coated tablets: Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets.

1 mg film-coated tablets: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.

3 mg, 5 mg, 7 mg film-coated tablets: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Date of first authorisation: 3 September 2012

Marketing authorization number:

EU/1/12/777/001
EU/1/12/777/002
EU/1/12/777/003
EU/1/12/777/004
EU/1/12/777/005
EU/1/12/777/006
EU/1/12/777/007
EU/1/12/777/008
EU/1/12/777/009
EU/1/12/777/010
EU/1/12/777/011
EU/1/12/777/012