Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Belville, 7530, RSA Company Contact Details: Customer Care: 080 222 6662
VORELLIX 5 film-coated tablets.
VORELLIX 10 film-coated tablets.
VORELLIX 15 film-coated tablets.
VORELLIX 20 film-coated tablets.
| Pharmaceutical Form |
|---|
|
VORELLIX 5: Pink coloured, almond shaped, biconvex, film-coated tablet debossed with “C5” on one side and “328” on the other side. VORELLIX 10: Yellow coloured, almond shaped, biconvex, film-coated tablet debossed with “C10” on one side and “329” on the other side. VORELLIX 15: Orange coloured, almond shaped, biconvex, film-coated tablet debossed with “C15” on one side and “543” on the other side. VORELLIX 20: Reddish brown coloured, almond shaped, biconvex, film-coated tablet debossed with “C20” on one side and “331” on the other side. |
VORELLIX 5: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
VORELLIX 10: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
VORELLIX 15: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
VORELLIX 20: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
Contains sugar: 58,50 mg mannitol
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vortioxetine |
Vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies. |
| List of Excipients |
|---|
|
VORELLIX 5 film-coated tablets: Tablet core: Amino methacrylate copolymer Tablet coating: Hypromellose VORELLIX 10 film-coated tablets: Tablet core: Amino methacrylate copolymer Tablet coating: Hypromellose VORELLIX 15 film-coated tablets: Tablet core: Amino methacrylate copolymer Tablet coating: Hypromellose VORELLIX 20 film-coated tablets: Tablet core: Amino methacrylate copolymer Tablet coating: Hypromellose |
VORELLIX 5, 10, 15 and 20: 50 cc HDPE container with 33 mm child resistant closure (blue) and silica gel bag 2,0 g containing 30 or 90 tablets per carton. or 200 cc HDPE container with 38 mm white screw cap and silica gel bag 5,0 g containing 500 tablets per carton.
Not all pack sizes may be marketed.
CIPLA MEDPRO (PTY) LTD., Building 9, Parc du Cap, Mispel Street, Belville, 7530, RSA
Company Contact Details: Customer Care: 080 222 6662
VORELLIX 5: 53/1.2/0699
VORELLIX 10: 53/1.2/0700
VORELLIX 15: 53/1.2/0701
VORELLIX 20: 53/1.2/0702
Date of first authorisation: 27 July 2021
| Drug | Countries | |
|---|---|---|
| VORELLIX | South Africa |
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