LYTGOBI Film-coated tablet Ref.[51058] Active ingredients: Futibatinib

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Taiho Pharma Netherlands B.V., Barbara Strozzilaan 201, ,1083HN Amsterdam, Netherlands

Product name and form

Lytgobi 4 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Round (6 mm), white, film-coated tablet debossed on one side with “4MG” and “FBN” on the reverse.

Qualitative and quantitative composition

Each film-coated tablet contains 4 mg of futibatinib.

Excipient with known effect: Each film-coated tablet contains 5.4 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Futibatinib

Constitutive fibroblast growth factor receptor (FGFR) signalling can support the proliferation and survival of malignant cells. Futibatinib is a tyrosine kinase inhibitor that irreversibly inhibits FGFR 1, 2, 3, and 4 by covalent binding.
List of Excipients

Tablet core:

Mannitol (E421)
Maize starch
Lactose monohydrate
Sodium laurilsulfate
Cellulose, microcrystalline
Crospovidone
Hydroxypropylcellulose (E463)
Magnesium stearate

Film-coating:

Hypromellose (E464)
Macrogols
Titanium dioxide (E171)

Lustering agent:

Magnesium stearate

Pack sizes and marketing

PVC/PCTFE laminated blisters with aluminium foil backing with one tablet per cavity. Each blister contains a 7-day supply of film-coated tablets sealed inside a folding cardboard wallet in the following three dose packs:

  • 20 mg daily dose: Each wallet contains 35 tablets (5 tablets once daily).
  • 16 mg daily dose: Each wallet contains 28 tablets (4 tablets once daily).
  • 12 mg daily dose: Each wallet contains 21 tablets (3 tablets once daily).

Not all pack sizes may be marketed.

Marketing authorization holder

Taiho Pharma Netherlands B.V., Barbara Strozzilaan 201, ,1083HN Amsterdam, Netherlands

Marketing authorization dates and numbers

Lytgobi 4 mg tablets:

EU/1/23/1741/001
EU/1/23/1741/002
EU/1/23/1741/003

Drugs

Drug Countries
LYTGOBI Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States
 
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