Source: Marketing Authorisation Holder Revision Year: 2014 Publisher: Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene Pretoria, South Africa
TREVIGO 8 mg TABLETS.
TREVIGO 16 mg TABLETS.
TREVIGO 24 mg TABLETS.
Betahistine dihydrochloride.
| Pharmaceutical Form |
|---|
|
TREVIGO 8 mg TABLETS: White to off–white round, flat, uncoated tablets debossed with ‘X’ on one side and ‘87’ on the other side. TREVIGO 16 mg TABLETS: White to off–white round, uncoated tablets, debossed with ‘X’ and a break line on one side and ‘88’ on the other side. TREVIGO 24 mg TABLETS: White to off–white round, uncoated tablets, debossed with ‘X’ and a break line on one side and ‘89’ on the other side. |
The active substance is betahistine dihydrochloride.
TREVIGO 8 mg tablets: Each uncoated tablet contains betahistine dihydrochloride 8 mg.
TREVIGO 16 mg tablets: Each uncoated tablet contains betahistine dihydrochloride 16 mg.
TREVIGO 24 mg tablets: Each uncoated tablet contains betahistine dihydrochloride 24 mg.
| Active Ingredient | Description | |
|---|---|---|
| Betahistine |
Betahistine dihydrochloride is a histamine-like drug in which pharmacological activity can be attributed to a specific effects and/or more direct influences on recovery mechanisms the vestibular nuclei. It has weak agonist activity at histamine H1 receptors and moderate antagonist activity at H3 receptors. Betahistine may increase blood flow to the cochlear region as well as to the whole brain. |
| List of Excipients |
|---|
|
Cellulose microcrystalline |
Blister Pack: Tablets are packed in blister packs (composed of OPA / aluminium foil / PVC film and printed aluminium foil).
Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blisters of 10 tablets each.
HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
Blister Pack: Tablets are packed in blister packs (composed of OPA / aluminium foil / PVC film and printed aluminium foil).
Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blisters of 10 tablets each.
HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
Blister Pack: Tablets are packed in blister packs (composed of OPA / aluminium foil / PVC film and printed aluminium foil).
Each blister contains 10 tablets.
Pack size: 20’s – Each carton contains 2 blisters of 10 tablets each.
HDPE Container Pack: Tablets are packed in 40 ml HDPE containers with polypropylene closures with induction sealing wad, containing cotton coil. Each container contains 30 tablets.
Pack size: 20’s – One HDPE container contains 20 tablets.
Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene – Pretoria, South Africa
TREVIGO 8 mg TABLETS: 45/5.6/0577
TREVIGO 16 mg TABLETS: 45/5.6/0578
TREVIGO 24 mg TABLETS: 45/5.6/0579
Date of Registration: 6 March 2014
| Drug | Countries | |
|---|---|---|
| TREVIGO | South Africa |
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