Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene-Pretoria, South Africa, (t) +27 12 345 3175
DENSATE 70 mg (Tablet) - Sodium alendronate.
| Pharmaceutical Form |
|---|
|
DENSATE 70 mg: White to off-white, oval shaped, biconvex, uncoated tablets, debossed with ‘F’ on one side and ‘21’ on the other side. |
The active substance is sodium alendronate.
DENSATE 70 mg: Each uncoated tablet contains sodium alendronate equivalent to alendronic acid 70 mg.
Sugar free.
| Active Ingredient | Description | |
|---|---|---|
| Alendronic acid |
Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with alendronic acid is of normal quality. |
| List of Excipients |
|---|
|
The other ingredients are cellulose microcrystalline, magnesium stearate, maize starch, povidone and sodium starch glycolate. |
DENSATE 70 mg: Tablets are packed in printed aluminium foil with heat seal lacquer and clear PVC laminated with aclar.
Each blister contains 4 tablets.
Pack size: 4’s – Each carton contains 1 blister of 4 tablets each.
Novagen Pharma (Pty) Ltd., Office 2, 100 Sovereign Drive, Route 21 Corporate Park, Nellmapius Drive, Irene-Pretoria, South Africa, (t) +27 12 345 3175
DENSATE 70 mg: 45/3.2/0581
Date of registration: 01 March 2013
Date of notification with regard to amended Reg. 9 and 10: 02 February 2015
| Drug | Countries | |
|---|---|---|
| DENSATE | Australia, South Africa |
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