Medicine
Mylotarg 5 mg/5 mL powder for injection
Mylotarg 5 mg/5 mL powder for injection is a prescription medicine containing Gemtuzumab ozogamicin for intravenous use, marketed by Wyeth 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. 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
Refrigerate (2°C to 8°C, 36°F to 46°F) MYLOTARG vials and store in the…
Key facts
- Active ingredient (INN)
- Gemtuzumab ozogamicin
- Brand
- Mylotarg
- Strength
- 5 mg/5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Wyeth Pharmaceuticals
- Manufacturer
- Wyeth Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Refrigerate (2°C to 8°C, 36°F to 46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FX02 Gemtuzumab ozogamicin
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 September 2017
- Identifiers
- RxCUI 1944701, 1944704DailyMed set ID 32fd2bb2-1cfa-4250-feb8-d7956c794e05NDC 0008-4510Application BLA761060
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 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0008-4510-01 | Wyeth Pharmaceuticals | 7 September 2017 |
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
Clinical summary
Gemtuzumab ozogamicin is a CD33-directed immunoconjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older, among other approved uses. MedsAcross supplies Gemtuzumab ozogamicin 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 Gemtuzumab ozogamicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mylotarg prescribing information (Wyeth Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Mylotarg: European public assessment report (EPAR) · European Medicines Agency
Need Mylotarg 5 mg/5 mL powder for 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.