Leaflet ENGERIX B 10mg/0.5ml 10mcg / 0.5ml injection suspension


Indicated for: prevention of hepatitis B

Substance: hepatitis B vaccine (vaccine)

ATC: J07BC01 (Antiinfectives for systemic use | Viral vaccines | Hepatitis vaccines)

The hepatitis B vaccine is used to prevent infection with the hepatitis B virus (HBV), which can cause acute and chronic hepatitis, liver cirrhosis, and liver cancer. The vaccine contains the hepatitis B surface antigen (HBsAg), produced using recombinant technology, which stimulates the immune system to produce specific antibodies against the virus.

The vaccine is administered intramuscularly, usually in three doses, following a standard schedule (0, 1, and 6 months). It is recommended for all newborns, children, adolescents, and unvaccinated adults, as well as individuals at high risk of infection, such as healthcare workers, dialysis patients, and travelers to endemic areas.

Common side effects include pain at the injection site, mild fever, and fatigue. In rare cases, severe allergic reactions may occur.

The hepatitis B vaccine is an essential measure for preventing HBV infection and its severe complications, contributing to public health protection.

General data about ENGERIX B 10mg/0.5ml 10mcg / 0.5ml

  • Substance: hepatitis B vaccine
  • Date of last drug list: 01-05-2026
  • Commercial code: W52082005
  • Concentration: 10mcg / 0.5ml
  • Pharmaceutical form: injection suspension
  • Packing volume: 0,5ml
  • Product type: original
  • Price: 48.80 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: GLAXOSMITHKLINE BIOLOGICALS S.A. - BELGIA
  • Holder: GLAXOSMITHKLINE BIOLOGICALS S.A. - BELGIA
  • Number: 6545/2014/05
  • Shelf life: 3 years

Pharmaceutical forms available for hepatitis B vaccine

Concentrations available for hepatitis B vaccine

  • 100mcg/5ml
  • 10mcg/0.5ml
  • 10mcg/5ml
  • 10mcg/ml
  • 200mcg/10ml
  • 20mcg/ml
  • 40mcg/ml
  • 5mcg/0.5ml

Compensation lists for ENGERIX B 10mg/0.5ml 10mcg / 0.5ml GlaxoSmithKline

E2 - Sublist E - section E2 with 100% discount from the reference price

Price

Copayment

Patient

48.80 RON

48.80 RON

0.00 RON