ROTARIX Powder and solvent for oral suspension Ref.[9867] Active ingredients: Rota virus

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: GlaxoSmithKline Biologicals s.a., Rue de lInstitut 89, B-1330, Rixensart, Belgium

Product name and form

Rotarix powder and solvent for oral suspension.

Rotavirus vaccine, live.

Pharmaceutical Form

Powder and solvent for oral suspension.

The powder is white.

The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.

Qualitative and quantitative composition

After reconstitution, 1 dose (1 ml) contains: Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50.

* Produced on Vero cells

Excipients with known effect: This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rota virus

Rotavirus vaccine is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P [8], G2P [4], G3P [8], G4P [8] and G9P [8].
List of Excipients

Powder:

Sucrose
Dextran
Sorbitol
Amino acids
Dulbecco’s Modified Eagle Medium (DMEM)

Solvent:

Calcium carbonate
Xanthan gum
Sterile water

Pack sizes and marketing

1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl).

1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl).

Transfer adapter for reconstitution (1/dose) in the following pack sizes:

  • pack size of 1 glass container of powder plus 1 oral applicator of solvent
  • pack size of 5 glass containers of powder plus 5 oral applicators of solvent
  • pack size of 10 glass containers of powder plus 10 oral applicators of solvent
  • pack size of 25 glass containers of powder plus 25 oral applicators of solvent

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330, Rixensart, Belgium

Marketing authorization dates and numbers

EU/1/05/330/001
EU/1/05/330/002
EU/1/05/330/003
EU/1/05/330/004

Date of first authorisation: 21 February 2006
Date of latest renewal: 14 January 2016

Drugs

Drug Countries
ROTARIX Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa
 
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