Medicine
Hemgenix kit
Hemgenix kit is a prescription medicine containing Etranacogene dezaparvovec, marketed by CSL Behring, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store HEMGENIX in the original carton until use. After dilution Once diluted…
Key facts
- Active ingredient (INN)
- Etranacogene dezaparvovec
- Brand
- Hemgenix
- Dosage form
- Kit
- Packs
- 1 kit and 36 more
- Marketing authorisation holder
- CSL Behring
- Manufacturer
- CSL Behring
- Origin register
- US FDA, United States
- Storage
- Store HEMGENIX in the original carton until use. After dilution Once diluted, store HEMGENIX in the infusion bag protected from light. Store diluted HEMGENIX in the infusion bag at 15°C to 25°C (59°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BD Medicines that stop bleeding, subgroup B02B, subgroup B02BD
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 November 2022
- Identifiers
- RxCUI 2626772, 2626778, 2626780 +7DailyMed set ID 35b2db65-4c6c-4173-ab56-b2bca69193bdNDC 0053-0240, 0053-0300, 0053-0330 +36Application BLA125772
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 * 1 injection, suspension in 1 vial, glass | 0053-0100-10 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0110-11 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0120-12 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0130-13 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0140-14 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0150-15 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0160-16 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0170-17 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0180-18 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0190-19 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0200-20 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0210-21 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0220-22 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0230-23 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0240-24 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0250-25 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0260-26 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0270-27 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0280-28 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0290-29 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0300-30 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0310-31 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0320-32 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0330-33 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0340-34 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0350-35 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0360-36 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0370-37 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0380-38 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0390-39 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0400-40 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0410-41 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0420-42 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0430-43 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0440-44 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0450-45 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0460-46 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0470-47 | CSL Behring | 22 November 2022 |
| 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass | 0053-0480-48 | CSL Behring | 22 November 2022 |
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
Etranacogene dezaparvovec is a prescription medicine indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated. MedsAcross supplies Etranacogene dezaparvovec 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 Etranacogene dezaparvovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HEMGENIX prescribing information (CSL Behring) · U.S. National Library of Medicine, DailyMed
- Hemgenix: European public assessment report (EPAR) · European Medicines Agency
Need Hemgenix 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.