Medicine
Wainua 45 mg/0.8 mL injection
Wainua 45 mg/0.8 mL injection is a prescription medicine containing Eplontersen for subcutaneous use, marketed by AstraZeneca 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
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton…
Key facts
- Active ingredient (INN)
- Eplontersen
- Brand
- Wainua
- Strength
- 45 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.8 mL
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton protected from light. Do not freeze. If not used within the 6 weeks stored at room temperature, discard WAINUA. If needed, WAINUA can be kept at room temperature (up to 30°C [86°F]) in the original carton for up to 6 weeks.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX21 Eplontersen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 December 2023
- Identifiers
- RxCUI 2671944, 2671950, 2741485 +1DailyMed set ID d7dcb847-71dd-4fff-82d0-d43a465fc096NDC 0310-9400, 0310-9420Application NDA217388
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 | 0310-9400-01 | AstraZeneca Pharmaceuticals | 21 December 2023 |
| 1 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 0310-9420-01 | AstraZeneca Pharmaceuticals | 30 April 2026 |
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
Eplontersen is an antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. It is available as injection for subcutaneous use. MedsAcross supplies Eplontersen 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 EplontersenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- WAINUA prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Wainzua: European public assessment report (EPAR) · European Medicines Agency
Need Wainua 45 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.