Medicine
Hemlibra 12 mg/0.4 mL injection
Hemlibra 12 mg/0.4 mL injection is a prescription medicine containing Emicizumab for subcutaneous use, marketed by Genentech, 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 HEMLIBRA vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Emicizumab
- Brand
- Hemlibra
- Strength
- 12 mg/0.4 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 0.4 mL
- Marketing authorisation holder
- Genentech
- Manufacturer
- Genentech
- Origin register
- US FDA, United States
- Storage
- Store HEMLIBRA vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Prior to administration, if needed, unopened vials of HEMLIBRA may be stored out of and then returned to refrigeration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B02BX06 Emicizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 January 2024
- Identifiers
- RxCUI 1989799, 1989804, 1989809 +7DailyMed set ID 2483adba-fab6-4d1b-96c5-c195577ed071NDC 50242-927Application BLA761083
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-use in 1 carton / .4 mL in 1 vial, single-use | 50242-927-01 | Genentech | 31 January 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.
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 Emicizumab
Clinical summary
Emicizumab is a prescription medicine indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency). MedsAcross supplies Emicizumab 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 EmicizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hemlibra prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Hemlibra: European public assessment report (EPAR) · European Medicines Agency
Need Hemlibra 12 mg/0.4 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.