Source: Health Products and Food Branch (CA) Revision Year: 2022
DEPAKENE – Valproic acid 250 mg/5 mL.
Table 2. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form/Strength/Composition | Non-medicinal Ingredients |
| Oral | Oral solution / 250 mg/5 mL | Artificial cherry flavor, FD&C Red No. 40, glycerin, hydrochloric acid*, methylparaben**, propylparaben**, purified water, sodium hydroxide*, sorbitol, sucrose***, vanillin. |
* hydrochloric acid and sodium hydroxide are used for pH adjustment.
** methylparaben and propylparaben may cause allergic reactions (possibly delayed).
*** DEPAKENE oral solution contains 3 g of sucrose per 5 mL dose.
DEPAKENE (valproic acid) oral solution is a red-coloured liquid containing the equivalent of 250 mg valproic acid, as the sodium salt, per 5 mL (50 mg/mL) supplied in 240 mL bottles.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
BGP Pharma ULC, 85 Advance Road, Etobicoke, Ontario, M8Z 2S6 261210 |
Date of approval:
Dec 22, 2014 July 7, 2022 |
| Drug | Countries | |
|---|---|---|
| DEPAKENE | Brazil, Canada, Japan, Mexico |
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