QDENGA Powder and solvent for solution for injection Ref.[50598] Active ingredients: Dengue vaccine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Takeda GmbH, Byk-Gulden-Str. 2, 78467 Konstanz, Germany

Product name and form

Qdenga powder and solvent for solution for injection.

Qdenga powder and solvent for solution for injection in pre-filled syringe.

Dengue tetravalent vaccine (live, attenuated).

Pharmaceutical Form

Powder and solvent for solution for injection.

Prior to reconstitution, the vaccine is a white to off-white coloured freeze-dried powder (compact cake).

The solvent is a clear, colourless solution.

Qualitative and quantitative composition

After reconstitution, 1 dose (0.5 mL) contains:

Dengue virus serotype 1* (live, attenuated): ≥3.3 log10 PFU**/dose.

Dengue virus serotype 2# (live, attenuated): ≥2.7 log10 PFU**/dose.

Dengue virus serotype 3* (live, attenuated): ≥4.0 log10 PFU**/dose.

Dengue virus serotype 4* (live, attenuated): ≥4.5 log10 PFU**/dose.

* Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs).
# Produced in Vero cells by recombinant DNA technology.
** PFU = Plaque-forming units.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dengue vaccine
List of Excipients

Powder:

α,α-Trehalose dihydrate
Poloxamer 407
Human serum albumin
Potassium dihydrogen phosphate
Disodium hydrogen phosphate
Potassium chloride
Sodium chloride

Solvent:

Sodium chloride
Water for injections

Pack sizes and marketing

Qdenga powder and solvent for solution for injection:

  • Powder (1 dose) in glass vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in glass vial (Type-I glass), with a stopper (bromobutyl rubber) and aluminium seal with purple flip-off plastic cap

Pack size of 1 or 10.

Qdenga powder and solvent for solution for injection in pre-filled syringe:

  • Powder (1 dose) in vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in pre-filled syringe (Type-I glass), with a plunger stopper (bromobutyl) and a tip cap (polypropylene), with 2 separate needles

Pack size of 1 or 5.

  • Powder (1 dose) in vial (Type-I glass), with a stopper (butyl rubber) and aluminium seal with green flip-off plastic cap + 0.5 mL solvent (1 dose) in pre-filled syringe (Type-I glass), with a plunger stopper (bromobutyl) and a tip cap (polypropylene), without needles

Pack size of 1 or 5.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda GmbH, Byk-Gulden-Str. 2, 78467 Konstanz, Germany

Marketing authorization dates and numbers

EU/1/22/1699/001
EU/1/22/1699/002
EU/1/22/1699/003
EU/1/22/1699/004
EU/1/22/1699/005
EU/1/22/1699/006

Drugs

Drug Countries
QDENGA Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom
 
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