Anpheros Search · Treatment

Cladribine

Also known as: Litak · Mavenclad

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In short

In the European Union, cladribine is indicated for the treatment of hairy-cell leukaemia. In the European Union, it is also indicated for the treatment of adult patients with highly active relapsing multiple sclerosis as defined by clinical or imaging features. In the United States, cladribine is indicated for the treatment of relapsing forms of multiple sclerosis in adults, including relapsing-remitting disease and active secondary progressive disease. Due to its safety profile, the United States labeling notes that its use is for patients with an inadequate response to, or an inability to tolerate, an alternate drug indicated for multiple sclerosis, and it is not for use in patients with clinically isolated syndrome.

From: Source: European Medicines Agency (EMA), Litak — EPAR, 03/04/2025. © European Medicines Agency. · Source: European Medicines Agency (EMA), Mavenclad — EPAR, 13/01/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
44157 cladribine
EMA
EMEA/H/C/000504, EMEA/H/C/004230

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) Cladribine

1 INDICATIONS AND USAGE Cladribine is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of cladribine is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5) ]. Cladribine is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of cladribine is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS. ( 1 , 5 ) Limitations of Use Cladribine is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile . ( 1 , 5 ) Limitations of Use Cladribine is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5) ].

Data provided by the U.S. Food and Drug Administration.

Document date: 20260619 · Official document →

EMA (EU) Litak

Litak is indicated for the treatment of hairy-cell leukaemia.

Source: European Medicines Agency (EMA), Litak — EPAR, 03/04/2025. © European Medicines Agency.

Document date: 03/04/2025 · Official document →

EMA (EU) Mavenclad

Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.

Source: European Medicines Agency (EMA), Mavenclad — EPAR, 13/01/2026. © European Medicines Agency.

Document date: 13/01/2026 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Cladribine approved for in the European Union?

Litak is indicated for the treatment of hairy-cell leukaemia. (Source: European Medicines Agency (EMA), Litak — EPAR, 03/04/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Litak — EPAR, 03/04/2025. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Mavenclad — EPAR, 13/01/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →