FYLREVY (Estetrol)

FYLREVY (estetrol) from Gedeon Richter is a hormone replacement therapy authorised in the EU on 26 March 2026 for oestrogen-deficiency symptoms, such as hot flushes, in postmenopausal women: both women who have had a hysterectomy and those who still have a uterus and have had no period for at least 12 months.

Estetrol (E4) is an oestrogen naturally produced by the human fetal liver. In two randomised, placebo-controlled trials, FYLREVY significantly reduced the frequency and severity of moderate to severe hot flushes and night sweats. Gedeon Richter developed it under the name Donesta. Women with a uterus also take a progestogen to protect the womb lining.

• It must not be used by women with known or suspected breast or other oestrogen-sensitive cancer, unexplained vaginal bleeding, untreated endometrial hyperplasia, past or current blood clots, heart attack or stroke, severe liver disease or porphyria.
• In women with a uterus (taking progesterone), endometrial thickening and vaginal bleeding are very common; breast tenderness and pain may also occur.
• As with all HRT, the lowest effective dose for the shortest time and regular review are recommended. The medicine is under additional monitoring.

Can FYLREVY be imported to India?

Yes. FYLREVY is authorised in the European Union. If a gynaecologist prescribes it, it can be imported in the patient’s name under the named-patient route.

Which strength is right?

The EU label starts women who still have a uterus on 14.2 mg once daily, with an increase to 18.9 mg if symptoms are not relieved enough; these women also take a progestogen continuously. Women who have had a hysterectomy take 18.9 mg. One tablet is taken once a day at about the same time, with or without food.

What documents do we need?

• A prescription from a gynaecologist stating the strength
• Gynaecologist’s notes confirming postmenopausal status and symptoms
• Government-issued photo ID of the patient (or the hospital’s details for hospital orders)

We confirm the order only after the prescription or requisition has been checked.

What pack sizes are there and how is it stored?

FYLREVY comes in packs of 28, 84 or 168 tablets (28 tablets per blister, with a storage case); not all pack sizes may be marketed. The EU label says it needs no special storage conditions, and its shelf life is 3 years.

An 84-tablet pack covers about three months of daily use, which many patients prefer for imports. IPN sources FYLREVY from authorised European distributors and imports it in the patient’s name.

For FYLREVY price in India and delivery time, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, or email info@indianpharmanetwork.in.

Global Approval Status:

• European Union: Marketing authorisation — 26 March 2026 (CHMP positive opinion 29 January 2026).
• United States: Not FDA-approved as of October 2026.

Sources:

• FYLREVY – EU product information (EMA EPAR)

Information last checked: October 2026.

What is FYLREVY indicated for?

It is a natural-type oestrogen (estetrol, E4) hormone therapy, prescribed for menopausal hot flushes and oestrogen-deficiency symptoms.

Which company makes FYLREVY?

Gedeon Richter.

What is the mechanism of FYLREVY?

FYLREVY contains synthetic estetrol, identical to the estetrol made by the fetal liver in pregnancy. It replaces the oestrogen the body stops making after menopause, which eases hot flushes and night sweats.

Is estetrol the same as estradiol?

No. Estetrol (E4) is a different natural oestrogen produced by the fetal liver during pregnancy.

Do I need to take a progestogen with FYLREVY?

If you still have a uterus, yes: the EU label says a progestogen should be added continuously to protect the womb lining. After a hysterectomy it is usually not needed.

Does FYLREVY have FDA approval?

Not as of October 2026.