Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
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. |
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 Tablet film-coating: Hypromellose 2910 (15 mPa·s) |
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
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
