Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Tarceva 25 mg film-coated tablets.
Tarceva 100 mg film-coated tablets.
Tarceva 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Tarceva 25 mg film coated tablets: White to yellowish, round, biconvex tablets with ‘T 25’ engraved on one side. Tarceva 100 mg film-coated tablets: White to yellowish, round, biconvex tablets with ‘T 100’ engraved on one side. Tarceva 150 mg film-coated tablets: White to yellowish, round, biconvex tablets with ‘T 150’ engraved on one side. |
Tarceva 25 mg film coated tablets: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).
Tarceva 100 mg film-coated tablets: Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Tarceva 150 mg film-coated tablets: Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).
Excipients with known effect:
Tarceva 25 mg film coated tablets: Each 25 mgfilm-coated tablet contains 27.43 mg Lactose monohydrate.
Tarceva 100 mg film-coated tablets: Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Tarceva 150 mg film-coated tablets: Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Erlotinib |
Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor. Erlotinib potently inhibits the intracellular phosphorylation of EGFR. EGFR is expressed on the cell surface of normal cells and cancer cells. Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coat: Hydroxypropyl cellulose (E463) |
PVC blister sealed with aluminium foil containing 30 tablets.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/05/311/001
EU/1/05/311/002
EU/1/05/311/003
Date of first authorization: 19 September 2005
Date of latest renewal: 2 July 2010
| Drug | Countries | |
|---|---|---|
| TARCEVA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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