Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
TIBILIVE 2,5 MG tablet.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white round uncoated tablets without any marking. |
Each tablet contains 2,5 mg of tibolone.
TIBILIVE 2,5 MG contains sugar (lactose monohydrate each tablet contains 43,15 mg and mannitol 43,15 mg).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tibolone |
Tibolone is rapidly metabolised into three compounds, which all contribute to the pharmacodynamic profile of tibolone. Two of the metabolites (3α-OH-tibolone and 3β-OH-tibolone) have oestrogenic-like activities, whereas the third metabolite (4Δ-isomer of tibolone) has progestogenic and androgenic-like activities. |
| List of Excipients |
|---|
|
Ascorbyl palmitate |
TIBILIVE 2,5 MG tablets are packed in PVC/Aluminium foil, blisters of 10 tablets, then placed in an outer carton. Each carton contains 30, 90 or 180 tablets.
Pharma Dynamics (Pty) Ltd, 1st Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
Tibilive 2,5 mg: A52/21.13/0078
Tibolone 2,5 mg Dyna: A52/21.13/0079
April 2022
| Drug | Countries | |
|---|---|---|
| TIBILIVE | South Africa |
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