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Qualitative and quantitative composition
Each film-coated tablet contains:
Active substance:
3.6 mg oclacitinib (as oclacitinib maleate).
5.4 mg oclacitinib (as oclacitinib maleate).
16 mg oclacitinib (as oclacitinib maleate).
Excipients:
Qualitative composition of excipients and other constituents
Tablet core:
Cellulose, microcrystalline
Lactose monohydrate
Magnesium stearate
Sodium starch glycolate
Tablet coating:
Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400 (E1521)
White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", or "M" or "L" on both sides. The letters "S", "M" and "L" refer to the different strengths of the tablets: "S" is on the 3.6 mg tablets, "M" is on the 5.4 mg tablets, and "L" on the 16 mg tablets.
The tablets can be divided into equal halves.