Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
Nerlynx 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Oval, red film-coated tablet with ‘W104’ debossed on one side. Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm. |
Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Neratinib |
Neratinib is an irreversible pan–erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3). This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Tablet coating: Polyvinyl alcohol |
60 mL white high density polyethylene (HDPE) round bottle with child-resistant, polypropylene closure, and foil induction inner seal.
An HDPE desiccant canister with 1 g silica gel is enclosed with the tablets in each bottle.
Each bottle contains 180 tablets.
PIERRE FABRE MEDICAMENT, Les Cauquillous, 81500 Lavaur, France
EU/1/18/1311/001
Date of first authorisation: 31st August 2018
| Drug | Countries | |
|---|---|---|
| NERLYNX | Austria, Canada, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States |
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