Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: SpringWorks Therapeutics Ireland Limited, Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland
Ogsiveo 50 mg film‑coated tablets.
Ogsiveo 100 mg film‑coated tablets.
Ogsiveo 150 mg film‑coated tablets.
| Pharmaceutical Form |
|---|
|
Film‑coated tablet (tablet). Ogsiveo 50 mg film‑coated tablets: Round, biconvex, orange film‑coated tablets 8 mm diameter, debossed with "50" on one side. Ogsiveo 100 mg film‑coated tablets: Round, light orange film‑coated tablets 10 mm diameter, debossed with "100" on one side. Ogsiveo 150 mg film‑coated tablets: Oval, yellow orange film‑coated tablets 8.5 mm in width, 17.5 mm in length, debossed with "150" on one side. |
Each film‑coated tablet contains 50 mg of nirogacestat (as nirogacestat dihydrobromide).
Excipients with known effect:
Each film-coated tablet contains 57.8 mg of lactose monohydrate.
Each film-coated tablet contains sunset yellow FCF (E110).
Each film‑coated tablet contains 100 mg of nirogacestat (as nirogacestat dihydrobromide).
Excipients with known effect:
Each film‑coated tablet contains 115.7 mg of lactose monohydrate.
Each film‑coated tablet contains sunset yellow FCF (E110).
Each film‑coated tablet contains 150 mg of nirogacestat (as nirogacestat dihydrobromide).
Excipients with known effect:
Each film‑coated tablet contains 173.5 mg of lactose monohydrate.
Each film‑coated tablet contains sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Nirogacestat is a reversible and non‑competitive inhibitor of gamma secretase that blocks proteolytic activation of the Notch receptor. |
| List of Excipients |
|---|
|
Tablet core: Cellulose, microcrystalline Tablet coating: Macrogol polyvinyl alcohol graft copolymer (E1209) |
Ogsiveo 50 mg film‑coated tablets:
HDPE bottle with child resistant closure and induction seal containing 120 or 180 tablets.
Ogsiveo 100 mg film‑coated tablets
Ogsiveo 150 mg film‑coated tablets:
Clear PVC/PVDC blisters with aluminium lidding containing 14 tablets. One pack contains 56 tablets in 4 blisters.
Not all pack sizes may be marketed.
SpringWorks Therapeutics Ireland Limited, Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland
EU/1/25/1932/001
EU/1/25/1932/002
EU/1/25/1932/003
EU/1/25/1932/004
Date of First Authorization: 14 August 2025
| Drug | Countries | |
|---|---|---|
| OGSIVEO | Austria, Estonia, Lithuania, Romania, United States |
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