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Medicine

Trogarzo 199.5 mg/1.33 mL injection

Ibalizumab · Intravenous · Theratechnologies
Available on requestPrescription onlyUS FDA Cold chain

Trogarzo 199.5 mg/1.33 mL injection is a prescription medicine containing Ibalizumab for intravenous use, marketed by Theratechnologies, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and…

Key facts

Active ingredient (INN)
Ibalizumab
Brand
Trogarzo
Strength
199.5 mg/1.33 mL
Dosage form
Injection
Route
Intravenous
Packs
2 vials of 1.33 mL
Marketing authorisation holder
Theratechnologies
Manufacturer
Theratechnologies
Origin register
US FDA, United States
Storage
Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and protect from light.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J05AX23 Ibalizumab
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
20 April 2018
Identifiers
RxCUI 2043317, 2043322DailyMed set ID c548ad82-9d1f-4d16-95b6-4e6106badf43NDC 62064-122Application BLA761065

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
2 vial, single-use in 1 carton / 1.33 mL in 1 vial, single-use62064-122-02Theratechnologies20 April 2018

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 6 March 2018Drugs@FDA
EU (EMA)WithdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Clinical summary

Ibalizumab is a CD4-directed blocking antibody indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. MedsAcross supplies Ibalizumab 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

Read about Ibalizumab

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

Data sources

Need Trogarzo 199.5 mg/1.33 mL injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.