Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Alunbrig 30 mg film-coated tablets.
Alunbrig 90 mg film-coated tablets.
Alunbrig 180 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Alunbrig 30 mg film-coated tablets: Round, white to off-white film-coated tablet of approximately 7 mm in diameter with debossed “U3” on one side and plain on the other side. Alunbrig 90 mg film-coated tablets: Oval, white to off-white film-coated tablet of approximately 15 mm in length with debossed “U7” on one side and plain on the other side. Alunbrig 180 mg film-coated tablets: Oval, white to off-white film-coated tablet of approximately 19 mm in length with debossed “U13” on one side and plain on the other side. |
Each film-coated tablet contains 30 mg of brigatinib.
Excipient with known effect: Each film-coated tablet contains 56 mg of lactose monohydrate.
Each film-coated tablet contains 90 mg of brigatinib.
Excipient with known effect: Each film-coated tablet contains 168 mg of lactose monohydrate.
Each film-coated tablet contains 180 mg of brigatinib.
Excipient with known effect: Each film-coated tablet contains 336 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Brigatinib |
Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R). It is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Talc |
Alunbrig 30 mg film-coated tablets:
Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap closures with foil induction seal liner, containing either 60 or 120 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 28, 56 or 112 film-coated tablets.
Alunbrig 90 mg film-coated tablets:
Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing either 7 or 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing either 7 or 28 film-coated tablets.
Alunbrig 180 mg film-coated tablets:
Round wide mouth high density polyethylene (HDPE) bottles with two-piece polypropylene child resistant screw cap with foil induction seal liner closures, containing 30 film-coated tablets, together with one HDPE canister containing a molecular sieve desiccant.
Clear thermoformable poly-chloro-tri-fluoro-ethylene (PCTFE) blister with heat sealable paper-laminated foil lidding in a carton, containing 28 film-coated tablets.
Treatment initiation pack Alunbrig 90 mg and 180 mg film-coated tablets:
Each pack consists of an outer carton with two inner cartons containing:
Not all pack sizes may be marketed.
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Alunbrig 30 mg film-coated tablets:
EU/1/18/1264/001 – 60 tablets in bottle
EU/1/18/1264/002 – 120 tablets in bottle
EU/1/18/1264/011 – 28 tablets in carton
EU/1/18/1264/003 – 56 tablets in carton
EU/1/18/1264/004 – 112 tablets in carton
Alunbrig 90 mg film-coated tablets:
EU/1/18/1264/005 – 7 tablets in bottle
EU/1/18/1264/006 – 30 tablets in bottle
EU/1/18/1264/007 – 7 tablets in carton
EU/1/18/1264/008 – 28 tablets in carton
Alunbrig 180 mg film-coated tablets:
EU/1/18/1264/009 – 30 tablets in bottle
EU/1/18/1264/010 – 28 tablets in carton
Alunbrig treatment initiation pack:
EU/1/18/1264/012 – 7 × 90 mg + 21 × 180 mg tablets in carton
Date of first authorisation: 22 November 2018
| Drug | Countries | |
|---|---|---|
| ALUNBRIG | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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