Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Daurismo 25 mg film-coated tablets.
Daurismo 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Daurismo 25 mg film-coated tablets: 7 mm round, yellow film-coated tablet debossed with “Pfizer” on one side and “GLS 25” on the other side. Daurismo 100 mg film-coated tablets: 11 mm round, pale orange film-coated tablet debossed with “Pfizer” on one side and “GLS 100” on the other side. |
Each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib.
Excipient with known effect: Each film-coated tablet contains 1.3 mg of lactose monohydrate.
Each film-coated tablet contains glasdegib maleate equivalent to 100 mg of glasdegib.
Excipient with known effect: Each film-coated tablet contains 5.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Glasdegib |
Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway that binds to Smoothened (SMO), a transmembrane protein, leading to decreased Glioma-Associated Oncogene (GLI) transcription factor activity and downstream pathway signalling. Hh pathway signalling is required for maintaining a leukaemic stem cell (LSC) population thus, glasdegib binding to and inhibiting SMO reduces GLI1 levels in AML cells and the leukaemic initiating potential of AML cells. |
| List of Excipients |
|---|
|
Tablet core: Sodium starch glycolate Film-coating: Lactose monohydrate |
PVC (polyvinyl chloride) blister sealed with aluminium foil containing 10 film-coated tablets, or high-density polyethylene (HDPE) bottle with polypropylene closure containing 30 or 60 film-coated tablets.
Daurismo 25 mg film-coated tablets:
One carton contains 60 film-coated tablets in 6 blisters.
One carton contains 60 film-coated tablets in an HDPE bottle.
Daurismo 100 mg film-coated tablets:
One carton contains 30 film-coated tablets in 3 blisters.
One carton contains 30 film-coated tablets in an HDPE bottle.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Daurismo 25 mg film-coated tablets:
EU/1/20/1451/001
EU/1/20/1451/002
Daurismo 100 mg film-coated tablets:
EU/1/20/1451/003
EU/1/20/1451/004
Date of first authorisation: 26 June 2020
| Drug | Countries | |
|---|---|---|
| DAURISMO | Austria, Canada, Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States |
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