Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: AOP Orphan Pharmaceuticals AG, Wilhelminenstrasse 91/II f, 1160 Vienna, Austria
Tardiben 25 mg tablets.
| Pharmaceutical Form |
|---|
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Tablet. Yellow, 7.0 × 2.8 mm round, with one-side break notch. The tablet can be divided into equal halves. |
Each tablet contains 25 mg Tetrabenazine.
Excipient with known effect: Each tablet contains 64.05 mg lactose monohydrate corresponding to 60.8 mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| List of Excipients |
|---|
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Maize starch (Cornstarch) pre-gelatinised |
White round high-density polyethylene (HDPE) tablet container with a child-resistant, tamper-evident polypropylene (PP) screw cap with mounted desiccant.
Tardiben is available in pack sizes of 42 and112 tablets.
Not all pack-sizes may be marketed.
AOP Orphan Pharmaceuticals AG, Wilhelminenstrasse 91/II f, 1160 Vienna, Austria
PL 21344/0016
07/07/2016
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