Medicine
Myfembree 1 mg/0.5 mg/40 mg tablet
Myfembree 1 mg/0.5 mg/40 mg tablet is a prescription medicine containing Estradiol, Norethindrone and Relugolix for oral use, marketed by Sumitomo Pharma, 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 at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC…
Key facts
- Active ingredient (INN)
- Estradiol, Norethindrone and Relugolix
- Brand
- Myfembree
- Strength
- 1 mg/0.5 mg/40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 28 tablets, 7 tablets
- Marketing authorisation holder
- Sumitomo Pharma
- Manufacturer
- Sumitomo Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 May 2021
- Identifiers
- DailyMed set ID fc3feb73-cc84-43a8-aa32-b262460495e8NDC 72974-415Application NDA214846
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 |
|---|---|---|---|
| 28 tablet, film coated in 1 bottle, plastic | 72974-415-01 | Sumitomo Pharma | 26 May 2021 |
| 7 tablet, film coated in 1 bottle, plastic | 72974-415-99 | Sumitomo Pharma | 7 July 2021 |
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 |
| US FDA | First approved 26 May 2021 | Drugs@FDA |
| 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
Clinical summary
Estradiol, Norethindrone and Relugolix is a fixed-dose combination of an estrogen, a gonadotropin releasing hormone receptor antagonist and a progestin. It is available as tablets for oral use. MedsAcross supplies Estradiol, Norethindrone and Relugolix 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 Estradiol, Norethindrone and RelugolixFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Myfembree prescribing information (Sumitomo Pharma) · U.S. National Library of Medicine, DailyMed
Need Myfembree 1 mg/0.5 mg/40 mg tablet 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.