Source: Health Products and Food Branch (CA) Revision Year: 2017
FLUANXOL – Flupentixol Tablets (as flupentixol dihydrochloride) 0.5 mg, 3 mg, and 5 mg.
FLUANXOL DEPOT – Flupentixol Decanoate Intramuscular Injection 2% and 10%.
| Route of Administration | Dosage Form/Strength | Nonmedicinal Ingredients |
|---|---|---|
| Oral | Tablet / 0.5 mg, 3 mg, 5 mg | Betadex, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, maize starch, talc, yellow iron oxide, sunset yellow FCF (FC&C yellow #6 aluminum lake), vegetable oil, water |
| Intramuscular injection | Depot / 2%, 10% | Medium-chain triglycerides |
Fluanxol 0.5 mg tablet: Each round, slightly bi-convex, yellow film-coated tablet is marked “FD” and contains 0.5 mg of flupentixol as the dihydrochloride. Available in bottles of 100.
Fluanxol 3 mg tablet: Each round, slightly bi-convex, ochre, film-coated tablet is marked “FI” and contains 3.0 mg of flupentixol as the dihydrochloride. Available in bottles of 100.
Fluanxol 5 mg tablet: Each oval, slightly bi-convex, ochre, film-coated tablet is marked “FK” and contains 5.0 mg of flupentixol as the dihydrochloride. Available in bottles of 100.
In addition to the active ingredient, flupentixol dihydrochloride, each tablet also contains the following nonmedicinal ingredients: Betadex, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, maize starch, talc, yellow iron oxide, sunset yellow FCF (FC&C yellow #6 aluminum lake), vegetable oil, water
Fluanxol Depot 2%: Each ampoule or vial contains cis(Z)-flupentixol decanoate 20 mg/mL in medium chain triglycerides. Available in the following formats:
Fluanxol Depot 10%: Each ampoule or vial of Fluanxol Depot 10% contains cis(Z)-flupentixol decanoate 100 mg/mL in medium chain triglycerides. Available in the following formats:
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Lundbeck Canada Inc., 2600 Alfred-Nobel, Suite 400, St-Laurent, QC, H4S 0A9 209135 |
Date of revision:
December 12, 2017 |
| Drug | Countries | |
|---|---|---|
| FLUANXOL DEPOT | Austria, Australia, Canada, Germany, Estonia, Hong Kong, Lithuania, Mexico, New Zealand, Poland, Romania, Singapore, Turkey |
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