LAZCLUZE Film-coated tablet Ref.[114943] Active ingredients: Lazertinib

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

Lazcluze 80 mg film-coated tablets.

Lazcluze 240 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Lazcluze 80 mg film-coated tablets: Yellow, 14 mm, oval tablet, debossed with “LZ” on one side and “80” on the other side.

Lazcluze 240 mg film-coated tablets: Reddish purple, 20 mm, oval tablet, debossed with “LZ” on one side and “240” on the other side.

Qualitative and quantitative composition

Lazcluze 80 mg film-coated tablets: Each film-coated tablet contains 80 mg lazertinib (as mesylate monohydrate).

Lazcluze 240 mg film-coated tablets: Each film-coated tablet contains 240 mg lazertinib (as mesylate monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

Lazertinib is an irreversible EGFR tyrosine kinase inhibitor (TKI). It selectively inhibits both primary activating EGFR mutations (exon 19 deletions and exon 21 L858R substitution mutations) and the EGFR T790M resistance mutation, while having less activity against wild-type EGFR.
List of Excipients

Tablet core:

Silica, hydrophobic colloidal
Croscarmellose sodium (E468)
Cellulose, microcrystalline (E460 (i))
Mannitol (E421)
Magnesium stearate (E572)

Film coating:

Lazcluze 80 mg film-coated tablets:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209)
Polyvinyl alcohol (E1203)
Glycerol monocaprylocaprate type I (E471)
Titanium dioxide (E171)
Talc (E553b)
Yellow iron oxide (E172)

Lazcluze 240 mg film-coated tablets:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209)
Polyvinyl alcohol (E1203)
Glycerol monocaprylocaprate type I (E471)
Titanium dioxide (E171)
Talc (E553b)
Red iron oxide (E172)
Black iron oxide (E172)

Pack sizes and marketing

Lazcluze 80 mg film-coated tablets:

Blister pack:

Polyvinyl chloride – polychlorotrifluoroethylene (PVC-PCTFE) film and aluminium push-through foil.

  • One carton contains 56 film-coated tablets (2 wallet packs containing 28 tablets each).

Bottle:

White opaque high-density polyethylene (HDPE) bottle with polypropylene child-resistant closure containing either 60 or 90 tablets. Each carton contains one bottle.

Lazcluze 240 mg film-coated tablets:

Blister pack:

Polyvinyl chloride – polychlorotrifluoroethylene (PVC-PCTFE) film and aluminium push-through foil.

  • One carton contains 14 film-coated tablets (1 wallet pack containing 14 tablets).
  • One carton contains 28 film-coated tablets (2 wallet packs containing 14 tablets each).

Bottle:

White opaque high-density polyethylene (HDPE) bottle with polypropylene child-resistant closure containing 30 film-coated tablets. Each carton contains one bottle.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/24/1886/001
EU/1/24/1886/002
EU/1/24/1886/003
EU/1/24/1886/004
EU/1/24/1886/005
EU/1/24/1886/006

Drugs

Drug Countries
LAZCLUZE Austria, France, Lithuania, United States
 
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