SPC: INLYTA Film-coated tablet (2019)

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.

List of excipients

Tablet core:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Tablet film-coating:

Hypromellose 2910 (15 mPaĀ·s)
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
Authorization dates

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

Date of first authorisation: 3 September 2012

Date of latest renewal: 22 May 2017

Marketing authorization number:

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