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MedsAcross

Molecule

Tisagenlecleucel

Autologous
Available on requestBiologicOrphanOncology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Tisagenlecleucel is a autologous. MedsAcross lists 2 presentations of it from 1 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Autologous, CD19-directed Chimeric Antigen Receptor, Cultured, Genetically-modified, Genetically-modified Autologous T Cells, T Lymphocytes, CD19 Receptor Interactions, Increased T Lymphocyte Activation
ATC classification
L01XL04 Tisagenlecleucel · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XL
US FDA first approval
Not recorded
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injectable suspension
Biologic
Yes
Identifiers
UNII Q6C9WHR03ORxCUI 1986438Q30314624

All presentations

2 presentations of Tisagenlecleucel, sorted by availability.

MedicineManufacturerRegisterAvailability
Kymriah 2000000 injectable suspensionIntravenousNovartis PharmaceuticalsUS FDAAvailable on request
Kymriah 60000000 injectable suspensionIntravenousNovartis PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Tisagenlecleucel in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Tisagenlecleucel available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Tisagenlecleucel and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tisagenlecleucel have?

The catalogue lists 1 brand names for Tisagenlecleucel, including Kymriah.

Is Tisagenlecleucel authorised in the European Union?

Yes. Tisagenlecleucel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Tisagenlecleucel need cold chain shipping?

No listed presentation of Tisagenlecleucel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Tisagenlecleucel in?

Tisagenlecleucel is classified under ATC code L01XL04 (Tisagenlecleucel).

References

  1. Kymriah: European public assessment report (EPAR). European Medicines Agency. Retrieved 1 September 2026

Request Tisagenlecleucel for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.