Koselugo Description

KOSELUGO 10 mg hard capsule: White to off-white, opaque, size 4 hard capsule, banded and marked with "SEL 10" in black ink.
KOSELUGO 25 mg hard capsule: Blue, opaque, size 4 hard capsule, banded and marked with "SEL 25" in black ink.
Each 10 mg hard capsule contains 10 mg of selumetinib (as hydrogen sulfate).
Each 25 mg hard capsule contains 25 mg of selumetinib (as hydrogen sulfate).
Excipients/Inactive Ingredients: 10 mg hard capsule: Capsule content: Vitamin E polyethylene glycol succinate (D α-tocopheryl polyethylene glycol 1000 succinate).
Capsule shell: Hypromellose (E 464), Carrageenan, Potassium chloride, Titanium dioxide (E 171), Carnauba wax and Purified water.
Printing ink: Shellac glaze, Iron oxide black, Propylene glycol, Ammonium hydroxide 28%.
25 mg hard capsule: Capsule content: Vitamin E polyethylene glycol succinate (D α-tocopheryl polyethylene glycol 1000 succinate).
Capsule shell: Hypromellose (E 464), Carrageenan, Potassium chloride, Titanium dioxide (E 171), FD&C Blue 2 (E 132), Ferric oxide yellow (E 172), Purified water, Carnauba wax and/or Corn starch.
Printing ink: Ferric oxide red, Ferric oxide yellow, FD&C blue 2 aluminium lake, Carnauba wax, White shellac, Glyceryl monooleate.