Hepsera 10 mg tablets Ref.[2461] Active ingredients: Adefovir dipivoxil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

Product name and form

Hepsera 10 mg tablets.

Pharmaceutical Form


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.

Qualitative and quantitative composition

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.

Active Ingredient
List of Excipients

Pregelatinised starch
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

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.

Marketing authorization holder

Gilead Sciences International Limited
CB21 6GT
United Kingdom

Marketing authorization dates and numbers


Date of first authorisation: 06 March 2003

Date of latest renewal: 06 March 2008


Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.