Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
WELIREG 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Blue, oval tablet, approximately 13 × 8 mm, debossed with markings “177” on one side. |
Each film-coated tablet contains 40 mg of belzutifan.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Belzutifan |
Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α). Belzutifan binds to HIF-2α, and in conditions of hypoxia or impairment of VHL protein function, belzutifan blocks the HIF-2α-HIF-1β interaction, leading to reduced transcription and expression of HIF-2α target genes. In vivo, belzutifan demonstrated anti-tumor activity in mouse xenograft models of renal cell carcinoma. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose acetate succinate Film-coating: Polyvinyl alcohol (E1203) |
Aluminium/aluminium blisters.
Pack containing 30 film-coated tablets.
Multipack containing 90 (3 packs of 30) film-coated tablets.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/24/1893/001
EU/1/24/1893/002
| Drug | Countries | |
|---|---|---|
| WELIREG | Canada, France, Israel, Lithuania, United Kingdom, United States |
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