Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Hepsera 10 mg tablets.
Tablet.
White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Each tablet contains 10 mg adefovir dipivoxil.
Excipient(s) with known effect:
Each tablet contains 113 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Pregelatinised starch
Croscarmellose sodium
Lactose monohydrate
Talc
Magnesium stearate
Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure. Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
The following pack sizes are available: outer cartons containing 1 × 30 tablet and 3 × 30 tablet bottles. Not all pack sizes may be marketed.
Gilead Sciences International Limited
Cambridge
CB21 6GT
United Kingdom
EU/1/03/251/001
EU/1/03/251/002
Date of first authorisation: 06 March 2003
Date of latest renewal: 06 March 2008
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