Leaflet ROTARIX oral suspension

Indicated for: prevention of rotavirus gastroenteritis

Route of administration: oral

Substance: rotavirus vaccine (vaccine)

ATC: J07BH01 (Antiinfectives for systemic use | Viral vaccines | Rotavirus diarrhea vaccines)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid live vaccines
Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage
Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light
Protect from light

Store protected from light.

The rotavirus vaccine is used to prevent severe gastroenteritis caused by rotavirus infection, a common illness in infants and young children. Rotavirus is a leading cause of severe diarrhea, which can result in severe dehydration and hospitalization, especially in the first years of life.

The vaccine is administered orally and is included in the vaccination schedule for infants. It is given in two or three doses, depending on the type of vaccine, usually starting at 6 weeks of age. It is important that all doses are completed before the age of 8 months.

The vaccine is highly effective in preventing severe forms of rotavirus gastroenteritis and significantly reduces the risk of hospitalization. It is well-tolerated, with side effects being rare and generally mild, such as irritability or minor gastrointestinal disturbances.

Rotavirus vaccination is an essential preventive measure to protect infant health and reduce the burden of the disease in the community. It is recommended by international health organizations and is widely available in many countries.

General data about ROTARIX

  • Substance: rotavirus vaccine
  • Date of latest medicines list: 01-06-2026
  • Product code: W53550001
  • Pharmaceutical form: oral suspension
  • Packing volume: 15ml
  • Product type: Original
  • Price: 287.45 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: GLAXO SMITHKLINE BIOLOGICALS SA - BELGIA
  • Holder: GLAXO SMITHKLINE BIOLOGICALS SA - BELGIA
  • Number: 330/2008/09
  • Shelf life: 3 years

Pharmaceutical forms available for rotavirus vaccine

PDF icon EMA leaflet
Published: 05/10/2009
Updated: 22/04/2026