REMSIMA Solution for injection Ref.[116266] Active ingredients: Infliximab

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary

Product name and form

Remsima 120 mg solution for injection in pre-filled syringe.

Remsima 120 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear to opalescent, colourless to pale brown solution.

Qualitative and quantitative composition

Remsima 120 mg solution for injection in pre-filled syringe: Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*.

Remsima 120 mg solution for injection in pre-filled pen: Each 1 mL single dose pre-filled pen contains 120 mg of infliximab*.

* Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.

Excipient(s) with known effect:

This medicine contains 45 mg sorbitol (E420) and 0.5 mg polysorbate 80 (E433) in each mL of solution.

For the full list of excipients, see section 6.1.

Active Ingredient

Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
List of Excipients

Acetic acid
Sodium acetate trihydrate
Sorbitol (E420)
Polysorbate 80 (E433)
Water for injections

Pack sizes and marketing

Remsima 120 mg solution for injection in pre-filled syringe:

Remsima 120 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.

Packs of:

  • 1 prefilled syringe (1 mL sterile solution) with 2 alcohol pads.
  • 2 prefilled syringes (1 mL sterile solution) with 2 alcohol pads.
  • 4 prefilled syringes (1 mL sterile solution) with 4 alcohol pads.
  • 6 prefilled syringes (1 mL sterile solution) with 6 alcohol pads.

Remsima 120 mg solution for injection in pre-filled syringe with automatic needle guard:

Remsima 120 mg solution for injection in single-use pre-filled syringe with automatic needle guard. The syringe is made from type I glass with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.

Packs of:

  • 1 prefilled syringe with automatic needle guard (1 mL sterile solution) with 2 alcohol pads.
  • 2 prefilled syringes with automatic needle guard (1 mL sterile solution) with 2 alcohol pads.
  • 4 prefilled syringes with automatic needle guard (1 mL sterile solution) with 4 alcohol pads.
  • 6 prefilled syringes with automatic needle guard (1 mL sterile solution) with 6 alcohol pads.

Remsima 120 mg solution for injection in pre-filled pen:

Remsima 120 mg solution for injection in single-use pre-filled pen. The syringe inside the pen is made from type 1 glass with a plunger stopper (flurotec-coated elastomer) and needle with a rigid needle shield.

Packs of:

  • 1 prefilled pen (1 mL sterile solution) with 2 alcohol pads.
  • 2 prefilled pens (1 mL sterile solution) with 2 alcohol pads.
  • 4 prefilled pens (1 mL sterile solution) with 4 alcohol pads.
  • 6 prefilled pens (1 mL sterile solution) with 6 alcohol pads.

Not all 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

EU/1/13/853/006
EU/1/13/853/007
EU/1/13/853/008
EU/1/13/853/009
EU/1/13/853/010
EU/1/13/853/011
EU/1/13/853/012
EU/1/13/853/013
EU/1/13/853/014
EU/1/13/853/015
EU/1/13/853/016
EU/1/13/853/017

Date of first authorisation: 22 November 2019

Drugs

Drug Countries
REMSIMA Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom
 
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