Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Secura Bio Limited, 32 Molesworth Street, Dublin 2, Ireland
Farydak 10 mg hard capsules.
Farydak 15 mg hard capsules.
Farydak 20 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Farydak 10 mg hard capsules: Light green opaque hard gelatin capsule (15.6–16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on cap and two radial bands in black ink on body. Farydak 15 mg hard capsules: Orange opaque hard gelatin capsule (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on cap and two radial bands in black ink on body. Farydak 20 mg hard capsules: Red opaque hard gelatin capsule (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on cap and two radial bands in black ink on body. |
Farydak 10 mg hard capsules: Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat.
Farydak 15 mg hard capsules: Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat.
Farydak 20 mg hard capsules: Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Panobinostat |
Panobinostat is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations. HDACs catalyse the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic alteration that results in a relaxing of chromatin, leading to transcriptional activation. |
| List of Excipients |
|---|
|
Capsule content: Magnesium stearate Capsule shell: Farydak 10 mg hard capsules: Gelatin Farydak 15 mg hard capsules: Gelatin Farydak 20 mg hard capsules: Gelatin Printing ink: Iron oxide, black (E172) |
PVC/PCTFE/Alu blister containing 6 capsules.
Packs containing 6, 12 or 24 capsules.
Not all pack sizes may be marketed.
Secura Bio Limited, 32 Molesworth Street, Dublin 2, Ireland
Farydak 10 mg hard capsules: EU/1/15/1023/001-003
Farydak 15 mg hard capsules: EU/1/15/1023/004-006
Farydak 20 mg hard capsules: EU/1/15/1023/007-009
Date of first authorisation: 28 August 2015
| Drug | Countries | |
|---|---|---|
| FARYDAK | Austria, Estonia, France, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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