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Hepsera 10 mg tablets (2012)

Active ingredients: Adefovir dipivoxil

Product Name and Form

Hepsera 10 mg tablets.

Pharmaceutical form

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.

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.

Chemical substance
Description
Adefovir dipivoxil

Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate. Adefovir diphosphate inhibits viral polymerases by competing for direct binding with the natural substrate (deoxyadenosine triphosphate) and, after incorporation into viral DNA, causes DNA chain termination.

List of excipients

Pregelatinised starch
Croscarmellose sodium
Lactose monohydrate
Talc
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
Authorization dates

Gilead Sciences International Limited
Cambridge
CB21 6GT
United Kingdom

Date of first authorisation: 06 March 2003

Date of latest renewal: 06 March 2008

Marketing authorization number:

EU/1/03/251/001
EU/1/03/251/002