Medicine
Dawnzera 80 mg/0.8 mL injection
Dawnzera 80 mg/0.8 mL injection is a prescription medicine containing Donidalorsen for subcutaneous use, marketed by Ionis 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Storage as on the product label
Key facts
- Active ingredient (INN)
- Donidalorsen
- Brand
- Dawnzera
- Strength
- 80 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.8 mL
- Marketing authorisation holder
- Ionis Pharmaceuticals
- Manufacturer
- Ionis Pharmaceuticals
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B06AC Other blood-related medicines, subgroup B06A, subgroup B06AC
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 August 2025
- Identifiers
- RxCUI 2724447, 2724453DailyMed set ID 3ff501e0-f75f-07da-e063-6294a90a0cb7NDC 71860-103Application NDA219407
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 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 71860-103-01 | Ionis Pharmaceuticals | 21 August 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
Clinical summary
Donidalorsen is a prescription medicine indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. It is available as injection for subcutaneous use. MedsAcross supplies Donidalorsen 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 DonidalorsenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DAWNZERA prescribing information (Ionis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Dawnzera: European public assessment report (EPAR) · European Medicines Agency
Need Dawnzera 80 mg/0.8 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.