STAMARIL Powder and solvent for suspension for injection Ref.[27697] Active ingredients: Yellow fever, live attenuated

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, FRANCE Distributed in the UK by: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

STAMARIL, powder and solvent for suspension for injection in pre-filled syringe.

Yellow fever vaccine (Live).

Pharmaceutical Form

Powder and solvent for suspension for injection.

Before reconstitution, the powder is homogeneous, beige to orange beige, and the solvent is a clear and colorless solution.

Qualitative and quantitative composition

After reconstitution, 1 dose (0.5 mL) contains:

Yellow fever virus1 17D-204 strain (live, attenuated) not less than 1000 IU.

1 produced in specified pathogen-free chick embryos

Excipients with known effects:

This product contains approximately 8 mg of sorbitol (E420) per dose.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Yellow fever, live attenuated
List of Excipients

Powder:

Lactose
Sorbitol E420
L-Histidine hydrochloride
L-Alanine
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Calcium chloride
Magnesium sulphate

Solvent:

Sodium chloride
Water for injections

Pack sizes and marketing

Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and an attached needle and needle-shield (natural rubber or polyisoprene) – pack size of 1, 10 or 20.

Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl), and a tip-cap (styrene – butadiene) – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.

Powder in vial (type I glass), with a stopper (chlorobutyl) and a flip-off cap (aluminium) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and a tip cap (styrene – butadiene) with 1 or 2 separate needles attached in the blister – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, FRANCE

Distributed in the UK by:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 46602/0007

03/09/2007

Drugs

Drug Countries
STAMARIL Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa
 
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