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Molecule

Talimogene laherparepvec

Available on requestBiologicCold chainOncology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Talimogene laherparepvec is a prescription medicine indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. It is available as injectable suspension for intralesional use. MedsAcross supplies Talimogene laherparepvec for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

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

Key facts

ATC classification
L01XL02 Talimogene laherparepvec · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XLL01XX51 Talimogene laherparepvec · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XX
US FDA first approval
Not recorded
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intralesional
Dosage forms
Injectable suspension
Biologic
Yes
Identifiers
UNII 07730V90L6RxCUI 1721264CAS 1187560-31-1DrugBank DB13896Q7679524

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

Source: US FDA prescribing information

How it works

IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.

Source: US FDA prescribing information

Dosing overview

For intralesional injection only. Do not administer intravenously. Administer IMLYGIC by injection into cutaneous, subcutaneous, and/or nodal lesions. Recommended starting dose is up to a maximum of 4 mL of IMLYGIC at a concentration of 10 6 (1 million) plaque-forming units (PFU) per mL. Subsequent doses should be administered up to 4 mL of IMLYGIC at a concentration of 10 8 (100 million) PFU per mL.

Source: US FDA prescribing information

Contraindications

Immunocompromised Patients. Pregnant Patients Immunocompromised Patients IMLYGIC is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.

Source: US FDA prescribing information

Warnings and precautions

Accidental Exposure to IMLYGIC: Accidental exposure may lead to transmission of IMLYGIC and herpetic infection. Healthcare providers and close contacts should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. Accidental Exposure to IMLYGIC continued: Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC. If accidental exposure occurs, exposed individuals should clean the affected area. Herpetic Infection: Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission. Injection Site Complications: Consider the risks and benefits before continuing IMLYGIC treatment if persistent infection or delayed healing develops.

Source: US FDA prescribing information

Side effects

The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. The following adverse reactions are discussed in greater detail in another section of the label: Herpetic Infection Injection Site Complications The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain.

Source: US FDA prescribing information

Interactions

IMLYGIC is sensitive to acyclovir. Acyclovir or other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC. No drug interaction studies have been conducted with IMLYGIC.

Source: US FDA prescribing information

Storage

Store and transport IMLYGIC at −90°C to −70°C (−130°F to −94°F). Store IMLYGIC in the carton until use.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Talimogene laherparepvec, sorted by availability.

MedicineManufacturerRegisterAvailability
Imlygic 1000000 PFU/mL injectable suspensionIntralesional Cold chainAmgenUS FDAAvailable on request
Imlygic 100000000 PFU/mL injectable suspensionIntralesional Cold chainAmgenUS 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 Talimogene laherparepvec in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Talimogene laherparepvec available for export from India?

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

What brand names does Talimogene laherparepvec have?

The catalogue lists 1 brand names for Talimogene laherparepvec, including Imlygic.

Is Talimogene laherparepvec authorised in the European Union?

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

Does Talimogene laherparepvec need cold chain shipping?

At least one listed presentation of Talimogene laherparepvec must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Talimogene laherparepvec in?

Talimogene laherparepvec is classified under ATC code L01XL02 (Talimogene laherparepvec).

References

  1. Imlygic prescribing information (Amgen). U.S. National Library of Medicine, DailyMed. Retrieved 29 November 2024
  2. Imlygic: European public assessment report (EPAR). European Medicines Agency. Retrieved 6 January 2026

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