Active ingredients: Axitinib
Inlyta 1 mg film-coated tablets.
Inlyta 3 mg film-coated tablets.
Inlyta 5 mg film-coated tablets.
Inlyta 7 mg film-coated tablets.
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.
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.
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.
Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate
Tablet film-coating:
Hypromellose 2910 (15 mPa·s)
Titanium dioxide (E171)
Lactose monohydrate
Triacetin (E1518)
Iron oxide red (E172)
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.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
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