MedeliX
Start asking

infliximab

Remicade · ATC code L04AB02

Brand names: Remicade, Avsola, Ixifi, Remsima, Tolurine

Key facts
Active substance
infliximab
Drug class
Immunosuppressive drug
ATC code
L04AB02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Remicade 100 mg powder for concentrate for solution for infusion.
Marketing authorisation holder
Janssen Cilag International NV
Information as of
2026-10-27

Key facts

Infliximab is a monoclonal antibody against tumour necrosis factor alpha (TNF blocker) given intravenously for inflammatory diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

What it is used for

  • Rheumatoid arthritis (with methotrexate) in adults
  • Crohn's disease (moderately to severely active or fistulising) in adults; severe, active disease in children and adolescents aged 6 to 17
  • Ulcerative colitis in adults; severely active disease in children and adolescents aged 6 to 17
  • Ankylosing spondylitis, psoriatic arthritis and moderate to severe plaque psoriasis in adults
  • Each after inadequate response to, or intolerance of, conventional therapies

Dosing

  • Rheumatoid arthritis: 3 mg/kg IV, repeated at 2 and 6 weeks, then every 8 weeks; with methotrexate; may be increased step-wise up to 7.5 mg/kg
  • Crohn's disease, ulcerative colitis, psoriatic arthritis, psoriasis: 5 mg/kg IV at weeks 0, 2 and 6, then every 8 weeks
  • Ankylosing spondylitis: 5 mg/kg at weeks 0, 2 and 6, then every 6 to 8 weeks
  • Children (6 to 17 years) with Crohn's disease or ulcerative colitis: 5 mg/kg at weeks 0, 2 and 6, then every 8 weeks
  • Reconsider therapy if no response within the stated time frames; further schemes in the full text

Contraindications

  • Hypersensitivity to infliximab, other murine proteins or any excipient
  • Tuberculosis or other severe infections (sepsis, abscesses, opportunistic infections)
  • Moderate or severe heart failure (NYHA class III/IV)

Important warnings

  • Acute infusion reactions including anaphylactic shock, and delayed hypersensitivity; emergency equipment must be available
  • Serious, sometimes fatal infections including tuberculosis; screen for active and latent tuberculosis before starting
  • Hepatitis B reactivation, including fatal cases; test for HBV before starting
  • Malignancies (including lymphoma, HSTCL), heart failure, demyelinating disorders and hepatobiliary events can occur
  • No concurrent live vaccines; traceability: record tradename and batch number

Side effects

  • Most common: upper respiratory tract infection (25.3% vs 16.5% in controls)
  • Serious: HBV reactivation, heart failure, serious infections (sepsis, TB), serum sickness, haematologic reactions, lupus-like syndrome, lymphoma and other malignancies, serious infusion reactions

Interactions

  • Methotrexate and other immunomodulators may reduce antibody formation against infliximab
  • Combination with other biologics for the same conditions (e.g. anakinra, abatacept) not recommended
  • Do not give live vaccines concurrently

Pregnancy and breastfeeding

  • Women of childbearing potential should use contraception for at least 6 months after the last dose; infants exposed in utero should wait twelve months before live vaccines
  • Infliximab is detected at low levels in human milk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Flixabi · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/004020
  • RemicadeJanssen Cilag International NV · EMEA/H/C/000240
  • Remsima · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/002576
  • Zessly · biosimilarSandoz GmbH · EMEA/H/C/004647

Source: European Medicines Agency (EMA), product information

Turkey

  • AvsolaAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry
  • IxifiPFİZER PFE İLAÇLARI A.Ş. · 1 register entry
  • RemicadeJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • RemsimaCELLTRİON HEALTHCARE İLAÇ SAN. VE TİC. LTD. ŞTİ. · 13 register entries
  • TolurineABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Remicade, Remsima, Zessly
Liechtenstein
Remicade, Remsima, Zessly
Norway
Remicade, Remsima, Zessly

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Remicade – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AB.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.