Medicine
Gozellix kit
Gozellix kit is a prescription medicine containing Gozetotide, marketed by Telix Innovations, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store GOZELLIX refrigerated upright in the original packaging at 2° to 8°C…
Key facts
- Active ingredient (INN)
- Gozetotide
- Brand
- Gozellix
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Telix Innovations
- Manufacturer
- Telix Innovations
- Origin register
- US FDA, United States
- Storage
- Store GOZELLIX refrigerated upright in the original packaging at 2° to 8°C (36° to 46°F). Do not freeze. After radiolabeling, keep Gallium Ga 68 Gozetotide Injection upright with appropriate shielding to protect from radiation at room temperature (25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V09I Diagnostic radiopharmaceuticals, subgroup V09I
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 March 2025
- Identifiers
- DailyMed set ID abeab169-e38e-433a-b8a9-f1dab31518c8NDC 84552-500Application NDA219592
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 carton * 2.5 mL in 1 vial, multi-dose * 6.4 mL in 1 vial, multi-dose * 2 mL in 1 ampule * 1 powder, for solution in 1 vial, multi-dose | 84552-500-25 | Telix Innovations | 20 March 2025 |
| 1 kit in 1 carton * 2.5 mL in 1 vial, multi-dose * 6.4 mL in 1 vial, multi-dose * 2 mL in 1 ampule * 1 powder, for solution in 1 vial, multi-dose | 84552-500-64 | Telix Innovations | 20 March 2025 |
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.
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
Other strengths and forms of Gozetotide
Clinical summary
Gozetotide is a prescription medicine indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer, among other approved uses. MedsAcross supplies Gozetotide 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 GozetotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LOCAMETZ prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Locametz: European public assessment report (EPAR) · European Medicines Agency
Need Gozellix kit 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.