Hepatitis B
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EMA approval · 2026-08-25EMA Authorised: Zutectra (human hepatitis B immunoglobulin) — Biotest Pharma GmbH
Zutectra, a human hepatitis B immunoglobulin, has been authorised by the EMA for use in immunization, with indications including hepatitis B…
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EMA approval · 2026-08-07EMA Authorised: Hexacima (hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid) — Sanofi Winthrop Industrie
EMA authorised Hexacima, a combination vaccine covering hepatitis B, diphtheria, pertussis, poliomyelitis, Haemophilus influenzae type b, te…
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EMA approval · 2026-08-07EMA Authorised: Hexyon (filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid) — Sanofi Winthrop Industrie
EMA has authorised Hexyon, a combined immunization vaccine covering multiple diseases including hepatitis B, diphtheria, tetanus, pertussis,…
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EMA approval · 2026-08-04EMA Authorised: Twinrix Adult (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Twinrix Adult (hepatitis A virus inactivated + hepatitis B surface antigen) has been authorised for use in adults by the EMA.
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EMA approval · 2026-08-03EMA Authorised: Twinrix Paediatric (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
The EMA has authorised Twinrix Paediatric, a combined hepatitis A and B vaccine for children, under the marketing authorization holder Glaxo…
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EMA approval · 2026-08-03EMA Authorised: Ambirix (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Ambirix, a vaccine containing inactivated hepatitis A virus and hepatitis B surface antigen, has been authorised for immunization against he…
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EMA approval · 2026-07-10EMA Authorised: Fendrix (hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Fendrix has been authorised by the EMA for use in its hepatitis B immunization program.
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EMA approval · 2026-07-10EMA Authorised: Infanrix Hexa (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);hepatitis B surface antigen;poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain));Haemophilus influenzae type b polysaccharide) — GlaxoSmithKline Biologicals S.A.
EMA has authorised Infanrix Hexa, a hexavalent vaccine by GlaxoSmithKline Biologicals S.A., covering multiple antigens including diphtheria,…
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EMA approval · 2026-06-12EMA Authorised: Zutectra (human hepatitis B immunoglobulin) — Biotest Pharma GmbH
Zutectra, a human hepatitis B immunoglobulin product by Biotest Pharma GmbH, has been authorised for use in immunization and passive immunit…
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EMA approval · 2026-03-31EMA Authorised: Vaxelis (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3;hepatitis B surface antigen produced in yeast cells;poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.) — MCM Vaccine B.V.
The EMA has authorised Vaxelis, a combination vaccine containing diphtheria and tetanus toxoids, pertussis antigens, hepatitis B surface ant…
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EMA approval · 2026-02-12EMA Authorised: Infanrix Hexa (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);hepatitis B surface antigen;poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain));Haemophilus influenzae type b polysaccharide) — GlaxoSmithKline Biologicals S.A.
The European Medicines Agency authorised Infanrix Hexa, a hexavalent vaccine that combines diphtheria, tetanus, pertussis, hepatitis B, poli…
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EMA approval · 2026-01-28EMA Authorised: Heplisav B (hepatitis B surface antigen) — Dynavax GmbH
The European Medicines Agency authorised Heplisav B, a hepatitis B vaccine based on hepatitis B surface antigen, for use in the European Uni…
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EMA approval · 2026-01-16EMA Authorised: Entecavir Viatris (previously Entecavir Mylan) (entecavir monohydrate) — Viatris Limited
The EMA authorised Entecavir Viatris (entecavir monohydrate) for the treatment of chronic hepatitis B.
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CLINICAL_TRIALS approval · 2025-12-15Clinical Trial Update: Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B
The update notes that a treatment for chronic hepatitis B, including patients regardless of HBeAg status, has been approved for marketing.
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EMA approval · 2025-12-03EMA Authorised: Baraclude (Entecavir) — Bristol-Myers Squibb Pharma EEIG
The European Medicines Agency authorised Baraclude (entecavir) for chronic hepatitis B. The marketing authorization holder is Bristol-Myers …
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EMA approval · 2025-11-18EMA Authorised: Viread (tenofovir disoproxil fumarate) — Gilead Sciences Ireland UC
The European Medicines Agency authorised Viread (tenofovir disoproxil fumarate) for chronic hepatitis B and HIV infections; the marketing au…
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EMA approval · 2025-11-07EMA Authorised: HBVaxPro (hepatitis B, recombinant surface antigen) — Merck Sharp & Dohme B.V.
EMA authorised HBVaxPro, a recombinant hepatitis B surface antigen vaccine, for immunization against hepatitis B in the European Union. The …
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EMA approval · 2025-11-05EMA Authorised: Pegasys (peginterferon alfa-2a) — pharmaand GmbH
EMA authorised Pegasys (peginterferon alfa-2a) for chronic hepatitis C, chronic hepatitis B, polycythemia vera, and essential thrombocythemi…
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EMA approval · 2025-10-15EMA Authorised: Zutectra (human hepatitis B immunoglobulin) — Biotest Pharma GmbH
The European Medicines Agency has authorised Zutectra, a human hepatitis B immunoglobulin, for passive immunization in hepatitis B infection…
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EMA approval · 2025-09-29EMA Authorised: Hexyon (filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid) — Sanofi Winthrop Industrie
EMA authorised Hexyon, a hexavalent vaccine combining protection against hepatitis B, diphtheria, tetanus, pertussis, Haemophilus influenzae…
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EMA approval · 2025-09-29EMA Authorised: Hexacima (hepatitis B surface antigen;Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett);Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein;tetanus toxoid) — Sanofi Winthrop Industrie
The European Medicines Agency authorised Hexacima, a hexavalent vaccine combining hepatitis B surface antigen, diphtheria toxoid, pertussis …
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EMA approval · 2025-06-03EMA Authorised: Zeffix (lamivudine) — GlaxoSmithKline Trading Services Limited
EMA authorised Zeffix (lamivudine) for chronic hepatitis B, with GlaxoSmithKline Trading Services Limited as the marketing authorisation hol…
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FDA approval · 2024-12-23FDA Approved: ENTECAVIR — Supplemental Application (Carlsbad Technology, Inc.)
FDA approved a supplemental application for entecavir (ENTECAVIR) submitted by Carlsbad Technology, Inc.
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FDA approval · 2024-12-23FDA Approved: ENTECAVIR — Original Application (Epic Pharma, LLC)
FDA approved Epic Pharma, LLC's original application for entecavir, a generic version of Baraclude, for the treatment of chronic hepatitis B…
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FDA approval · 2024-12-19FDA Approved: ENTECAVIR — Supplemental Application (Solco Healthcare LLC)
FDA approved a Supplemental Application for ENTECAVIR from Solco Healthcare LLC, enabling continuation of marketing and manufacturing of the…