Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Vizimpro 15 mg film-coated tablets.
Vizimpro 30 mg film-coated tablets.
Vizimpro 45 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Vizimpro 15 mg film-coated tablets: Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other. Vizimpro 30 mg film-coated tablets: Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other. Vizimpro 45 mg film-coated tablets: Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other. |
Vizimpro 15 mg film-coated tablets: Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Excipients with known effect: Each film-coated tablet contains 40 mg of lactose monohydrate.
Vizimpro 30 mg film-coated tablets: Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib.
Excipients with known effect: Each film-coated tablet contains 81 mg of lactose monohydrate.
Vizimpro 45 mg film-coated tablets: Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib.
Excipients with known effect: Each film-coated tablet contains 121 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dacomitinib |
Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R substitution in exon 21. Dacomitinib binds selectively and irreversibly to its HER family targets thereby providing prolonged inhibition. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film coating: Opadry II Blue 85F30716 containing: |
Aluminium/aluminium blister containing 10 film-coated tablets. Each pack contains 30 film-coated tablets.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/19/1354/001
EU/1/19/1354/002
EU/1/19/1354/003
| Drug | Countries | |
|---|---|---|
| VIZIMPRO | Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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