YUFLYMA 40 mg Solution for injection Ref.[28034] Active ingredients: Adalimumab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary

Product name and form

Yuflyma 40 mg solution for injection in pre-filled syringe.

Yuflyma 40 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear to slightly opalescent, colourless to pale brown solution.

Qualitative and quantitative composition

Yuflyma 40 mg solution for injection in pre-filled syringe:

Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab.

Yuflyma 40 mg solution for injection in pre-filled pen:

Each 0.4 ml single dose pre-filled pen contains 40 mg of adalimumab.

Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Adalimumab

Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
List of Excipients

Acetic acid
Sodium acetate trihydrate
Glycine
Polysorbate 80
Water for injections

Pack sizes and marketing

Yuflyma 40 mg solution for injection in pre-filled syringe

Solution for injection in a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled syringe (0.4 ml sterile solution) with 2 alcohol pads.
  • 2 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad.
  • 4 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad.
  • 6 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad.

Yuflyma 40 mg solution for injection in pre-filled syringe with needle guard

The syringe is made from type I glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled syringe with needle guard (0.4 ml sterile solution) with 2 alcohol pads.
  • 2 pre-filled syringes with needle guard (0.4 ml sterile solution), each with 1 alcohol pad.
  • 4 pre-filled syringes with needle guard (0.4 ml sterile solution), each with 1 alcohol pad.
  • 6 pre-filled syringes with needle guard (0.4 ml sterile solution), each with 1 alcohol pad.

Yuflyma 40 mg solution for injection in pre-filled pen

Solution for injection in a pre-filled pen for patient use containing a pre-filled syringe. The syringe inside the pen is made from type 1 glass with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).

Packs of:

  • 1 pre-filled pen (0.4 ml sterile solution), with 2 alcohol pads.
  • 2 pre-filled pens (0.4 ml sterile solution), each with 1 alcohol pad.
  • 4 pre-filled pens (0.4 ml sterile solution), each with 1 alcohol pad.
  • 6 pre-filled pens (0.4 ml sterile solution), each with 1 alcohol pad.

Not all presentations or pack sizes may be marketed.

Marketing authorization holder

Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary

Marketing authorization dates and numbers

Yuflyma 40 mg solution for injection in pre-filled syringe:

EU/1/20/1513/001
EU/1/20/1513/002
EU/1/20/1513/003
EU/1/20/1513/004

Yuflyma 40 mg solution for injection in pre-filled syringe with needle guard:

EU/1/20/1513/005
EU/1/20/1513/006
EU/1/20/1513/007
EU/1/20/1513/008

Yuflyma 40 mg solution for injection in pre-filled pen:

EU/1/20/1513/009
EU/1/20/1513/010
EU/1/20/1513/011
EU/1/20/1513/012

Date of first authorisation: 11 February 2021

Drugs

Drug Countries
YUFLYMA Austria, Germany, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom
 
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