INLYTA Film-coated tablet Ref.[6318] Active ingredients: Axitinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

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).

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

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

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

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

Qualitative and quantitative composition

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

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

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

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

Excipients with known effect:

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

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

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

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

For the full list of excipients, see section 6.1.

Active Ingredient 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 2910 (15 mPaยทs)
Titanium dioxide (E171)
Lactose monohydrate
Triacetin (E1518)
Iron oxide red (E172)

Pack sizes and marketing

Inlyta 1 mg film-coated tablet:

Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets.

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

Inlyta 3 mg film-coated tablet:

Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets.

HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.

Inlyta 5 mg film-coated tablet:

Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 film-coated tablets.

HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.

Inlyta 7 mg film-coated tablet:

Aluminium/aluminium blister containing 14 film-coated tablets. Each pack contains 28 or 56 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

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization dates and numbers

Inlyta 1 mg film-coated tablets:

EU/1/12/777/001
EU/1/12/777/002
EU/1/12/777/003

Inlyta 3 mg film-coated tablets:

EU/1/12/777/007
EU/1/12/777/008
EU/1/12/777/009

Inlyta 5 mg film-coated tablets:

EU/1/12/777/004
EU/1/12/777/005
EU/1/12/777/006

Inlyta 7 mg film-coated tablets:

EU/1/12/777/010
EU/1/12/777/011
EU/1/12/777/012

Date of first authorisation: 3 September 2012
Date of latest renewal: 22 May 2017

Drugs

Drug Countries
INLYTA Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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