Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Lorviqua 25 mg film-coated tablets.
Lorviqua 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Lorviqua 25 mg film-coated tablets: Round (8 mm) light pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side. Lorviqua 100 mg film-coated tablets: Oval (8.5 × 17 mm) dark pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side. |
Lorviqua 25 mg film-coated tablets: Each film-coated tablet contains 25 mg of lorlatinib.
Excipient with known effect: Each film-coated tablet contains 1.58 mg of lactose monohydrate.
Lorviqua 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of lorlatinib.
Excipient with known effect: Each film-coated tablet contains 4.20 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lorlatinib |
Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Hypromellose |
OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.
Lorviqua 25 mg film-coated tablets: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Lorviqua 100 mg film-coated tablets: Each pack contains 30 film-coated tablets in 3 blisters.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/19/1355/001
EU/1/19/1355/002
EU/1/19/1355/003
Date of first authorisation: 6 May 2019
| Drug | Countries | |
|---|---|---|
| LORVIQUA | Austria, Australia, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
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