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Medicine

Gavreto 100 mg capsule

Pralsetinib · Oral · Rigel Pharmaceuticals
Available on requestPrescription onlyUS FDA

Gavreto 100 mg capsule is a prescription medicine containing Pralsetinib for oral use, marketed by Rigel Pharmaceuticals, 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.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to…

Key facts

Active ingredient (INN)
Pralsetinib
Brand
Gavreto
Strength
100 mg
Dosage form
Capsule
Route
Oral
Packs
120 capsules, 60 capsules, 90 capsules
Marketing authorisation holder
Rigel Pharmaceuticals
Manufacturer
Rigel Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F). Protect from moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01EX23 Pralsetinib
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
24 June 2024
Identifiers
RxCUI 2394941, 2394947DailyMed set ID 16edd46e-28b8-f06d-e063-6394a90ae31bNDC 71332-006Application NDA213721

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
120 capsule in 1 bottle71332-006-12Rigel Pharmaceuticals24 June 2024
60 capsule in 1 bottle71332-006-60Rigel Pharmaceuticals24 June 2024
90 capsule in 1 bottle71332-006-90Rigel Pharmaceuticals24 June 2024

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 4 September 2020Drugs@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

Pralsetinib is a kinase inhibitor indicated for treatment of adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC), among other approved uses. MedsAcross supplies Pralsetinib 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 Pralsetinib

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

Data sources

Need Gavreto 100 mg capsule 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.