ROTARIX oral suspension medication leaflet

J07BH01 rotavirus vaccine • Antiinfectives for systemic use | Viral vaccines | Rotavirus diarrhea vaccines

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 last drug list: 01-04-2026

Commercial code: W53550001

Pharmaceutical form: oral suspension

Packing volume: 15ml

Product type: original

Price: 287.45 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

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: 27/05/2024