ZINBRYTA Solution for injection Ref.[8979] Active ingredients: Daclizumab

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: BIOGEN IDEC Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom

Product name and form

Zinbryta 150 mg solution for injection in pre-filled syringe.

Zinbryta 150 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Colourless to slightly yellow, clear to slightly opalescent liquid with pH 6.

Qualitative and quantitative composition

Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.

Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection.

Daclizumab beta is produced in a mammalian cell line (NS0) by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Daclizumab

Daclizumab beta is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2RĪ±), and prevents IL-2 binding to CD25, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor. Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
List of Excipients

Sodium succinate
Succinic acid
Sodium chloride
Polysorbate 80
Water for injections

Pack sizes and marketing

Pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield containing 1 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.

Pack sizes:

  • Pack containing one 150 mg pre-filled syringe.
  • 3 month multipack containing three 150 mg pre-filled syringes (3 boxes containing 1 syringe each).

A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen. The syringe inside the pen is a pre-filled syringe made of glass (Type 1) with a rubber stopper and thermoplastic rigid needle shield, containing 1 mL of solution. A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.

Pack sizes:

  • Pack containing one 150 mg pre-filled pen.
  • 3 month multipack containing three 150 mg pre-filled pens (3 boxes containing 1 pen each).

Not all pack sizes may be marketed

Marketing authorization holder

BIOGEN IDEC Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom

Marketing authorization dates and numbers

EU/1/16/1107/001
EU/1/16/1107/002
EU/1/16/1107/003
EU/1/16/1107/004

Date of first authorisation: 01 July 2016

Drugs

Drug Countries
ZINBRYTA Estonia, Lithuania
 
Next: Usage >

Ā© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈