BALVERSA Film-coated tablet Ref.[111498] Active ingredients: Erdafitinib

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

Balversa 3 mg film-coated tablets.

Balversa 4 mg film-coated tablets.

Balversa 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

3 mg tablets: Yellow, round biconvex shaped film-coated tablet, 7.6 mm in diameter, debossed with “3” on one side; and “EF” on the other side.

4 mg tablets: Orange, round biconvex shaped film-coated tablet, 8.1 mm in diameter, debossed with “4” on one side; and “EF” on the other side.

5 mg tablets: Brown, round biconvex shaped film-coated tablet, 8.6 mm in diameter, debossed with “5” on one side; and “EF” on the other side.

Qualitative and quantitative composition

Balversa 3 mg film-coated tablets: Each film-coated tablet contains 3 mg of erdafitinib.

Balversa 4 mg film-coated tablets: Each film-coated tablet contains 4 mg of erdafitinib.

Balversa 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of erdafitinib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Erdafitinib

Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. Erdafitinib increases serum phosphate concentration, a secondary effect of FGFR inhibition.
List of Excipients

Balversa 3 mg film-coated tablets

Tablet core:

Croscarmellose sodium
Magnesium stearate (E572)
Mannitol (E421)
Meglumine
Microcrystalline cellulose (E460)

Film-coating (Opadry amb II):

Glycerol monocaprylocaprate Type I
Polyvinyl alcohol-partially hydrolysed
Sodium lauryl sulfate
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)

Balversa 4 mg film-coated tablets

Tablet core:

Croscarmellose sodium
Magnesium stearate (E572)
Mannitol (E421)
Meglumine
Microcrystalline cellulose (E460)

Film-coating (Opadry amb II):

Glycerol monocaprylocaprate Type I
Polyvinyl alcohol-partially hydrolysed
Sodium lauryl sulfate
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)

Balversa 5 mg film-coated tablets

Tablet core:

Croscarmellose sodium
Magnesium stearate (E572)
Mannitol (E421)
Meglumine
Microcrystalline cellulose (E460)

Film-coating (Opadry amb II):

Glycerol monocaprylocaprate Type I
Polyvinyl alcohol-partially hydrolysed
Sodium lauryl sulfate
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

Bottle:

HDPE (high-density polyethylene) bottle with a child-resistant PP (polypropylene) closure and induction seal liner. Each carton contains one bottle with 28, 56 or 84 film-coated tablets.

3 mg tablet:

  • Each carton of 56 film-coated tablets contains one bottle of 56 tablets.
  • Each carton of 84 film-coated tablets contains one bottle of 84 tablets.

4 mg tablet:

  • Each carton of 28 film-coated tablets contains one bottle of 28 tablets.
  • Each carton of 56 film-coated tablets contains one bottle of 56 tablets.

5 mg tablet:

  • Each carton of 28 film-coated tablets contains one bottle of 28 tablets. Blister PVC-PCTFE (polyvinyl chloride-polychlorotrifluoroethylene) blister with aluminium push-through foil. The blister(s) are supplied in a carton.

3 mg tablet:

  • Each 28-day carton of 56 film-coated tablets contains two blister wallet packs of 28 tablets each.
  • Each 28-day carton of 84 film-coated tablets contains two blister wallet packs of 42 tablets each.

4 mg tablet:

  • Starter pack: 7-day carton which contains one blister wallet pack with a total 14 film-coated tablets of 4 mg for 1 week treatment. To be used for the starting dose before any dose up-titration or dose reduction.
  • Each 28-day carton of 28 film-coated tablets contains one blister wallet pack of 28 tablets.
  • Each 28-day carton of 56 film-coated tablets contains two blister wallet packs of 28 tablets each.

5 mg tablet:

  • Each 28-day carton of 28 film-coated tablets contains one blister wallet pack of 28 tablets.

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/1/24/1841/001
EU/1/24/1841/002
EU/1/24/1841/003
EU/1/24/1841/004
EU/1/24/1841/005
EU/1/24/1841/006
EU/1/24/1841/007
EU/1/24/1841/008
EU/1/24/1841/009
EU/1/24/1841/010
EU/1/24/1841/011

 
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