Medicine
Berinert kit
Berinert kit is a prescription medicine containing Human c1-esterase inhibitor, 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
Do not freeze. When stored at temperatures of 2-30°C (36-86°F), BERINERT is…
Key facts
- Active ingredient (INN)
- Human c1-esterase inhibitor
- Brand
- Berinert
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- CSL Behring
- Manufacturer
- CSL Behring
- Origin register
- US FDA, United States
- Storage
- Do not freeze. When stored at temperatures of 2-30°C (36-86°F), BERINERT is stable for the period indicated by the expiration date on the carton and vial label. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 December 2011
- Identifiers
- RxCUI 867381, 1729336DailyMed set ID 8ea0c7fe-da9d-4218-a080-0509e09bedc6NDC 63833-825Application BLA125287
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 * 10 mL in 1 vial * 10 mL in 1 vial | 63833-825-02 | CSL Behring | 22 December 2011 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Alternatives
Other makers and brands of Human c1-esterase inhibitor kit.
Other strengths and forms of Human c1-esterase inhibitor
Clinical summary
Human c1-esterase inhibitor is a human C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). MedsAcross supplies Human c1-esterase inhibitor 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 Human c1-esterase inhibitorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cinryze prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Berinert 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.