Source: Health Products and Food Branch (CA) Revision Year: 2022
BRIVLERA 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg tablets, 10mg/mL oral solution and 10 mg/mL solution for injection.
Table 2. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form/Strength/Composition | Nonmedicinal Ingredients |
|---|---|---|
| Oral | Tablets / 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg / bottle | Anhydrous lactose, betadex (β-cyclodextrin), croscarmellose sodium, lactose monohydrate, and magnesium stearate and additional ingredients listed below: 10 mg tablets: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide 25 mg and 100 mg tablets: black iron oxide polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, yellow iron oxide 50 mg tablets: polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, yellow iron oxide 75 mg tablets: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, yellow iron oxide |
| Oral | Oral solution / 10 mg/mL / bottle | Anhydrous citric acid, carboxymethylcellulose sodium, glycerin, methylparaben, raspberry flavour, purified water, sodium citrate, sorbitol solution, and sucralose |
| Intravenous | Solution for injection / 10 mg/mL / vial | Glacial acetic acid, sodium acetate (trihydrate), sodium chloride, and water for injection |
BRIVLERA tablets are supplied as follows:
10 mg Tablets: BRIVLERA (brivaracetam) tablets 10 mg are white to off-white, round, filmcoated, and debossed with “u10” on one side.
25 mg Tablets: BRIVLERA (brivaracetam) tablets 25 mg are gray, oval, film-coated, and debossed with “u25” on one side.
50 mg Tablets: BRIVLERA (brivaracetam) tablets 50 mg are yellow, oval, film-coated, and debossed with “u50” on one side.
75 mg Tablets: BRIVLERA (brivaracetam) tablets 75 mg are purple, oval, film-coated, and debossed with “u75” on one side.
100 mg Tablets: BRIVLERA (brivaracetam) tablets 100 mg are green-gray, oval, film-coated, and debossed with “u100” on one side.
BRIVLERA tablets are supplied in white HDPE bottles of 60 tablets, PVC/PCTFE – Aluminium blisters of 14 tablets and single unit dose blisters.
BRIVLERA (brivaracetam) oral solution 10 mg/mL is a slightly viscous, clear, colourless to yellow, raspberry-flavoured liquid.
BRIVLERA (brivaracetam) oral solution 10 mg/mL is supplied in 300 mL amber glass bottles.
BRIVLERA (brivaracetam) solution for injection 10mg/mL is a clear, colourless, sterile solution.
BRIVLERA solution for injection 10 mg/mL is supplied in 6 mL colourless single-use glass vials. Each vial contains 5 mL of brivaracetam solution for injection.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
UCB Canada Inc., Oakville, ON, L6H 0J8 249184 |
Date of approval:
Mar 9, 2016 June 30, 2021 |
| Drug | Countries | |
|---|---|---|
| BRIVLERA | Brazil, Canada |
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