🇪🇺 Lamivudine plus adefovir in European Union

EMA authorised Lamivudine plus adefovir on 29 July 1999

Marketing authorisation

EMA — authorised 29 July 1999

  • Application: EMEA/H/C/000242
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Zeffix
  • Indication: Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.
  • Status: approved

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Lamivudine plus adefovir in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Lamivudine plus adefovir approved in European Union?

Yes. EMA authorised it on 29 July 1999.

Who is the marketing authorisation holder for Lamivudine plus adefovir in European Union?

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.