Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
FYLREVY 14.2 mg film-coated tablets.
FYLREVY 18.9 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. FYLREVY 14.2 mg film-coated tablets: The film-coated tablet is orange, 6 mm diameter, round, biconvex with a drop-shaped debossing on one side. FYLREVY 18.9 mg film-coated tablets: The film-coated tablet is yellow, 6 mm diameter, round, biconvex with a drop-shaped debossing on one side. |
Each film-coated tablet contains 14.2 mg estetrol (as estetrol monohydrate).
Excipient with known effect:
Each film-coated tablet contains 42.9 mg lactose monohydrate.
Each film-coated tablet contains 18.9 mg estetrol (as estetrol monohydrate).
Excipient with known effect:
Each film-coated tablet contains 37.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Hypromellose (E464) |
Transparent PVC/aluminium blister containing 28 film-coated tablets in a carton with an etui storage case.
Pack sizes:
28, 84 or 168 film-coated tablets.
Not all pack sizes may be marketed.
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
FYLREVY 14.2 mg film-coated tablets
EU/1/26/2020/001
EU/1/26/2020/002
EU/1/26/2020/003
FYLREVY 18.9 mg film-coated tablets
EU/1/26/2020/004
EU/1/26/2020/005
EU/1/26/2020/006
| Drug | Countries | |
|---|---|---|
| FYLREVY | Estonia |
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