Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Pemazyre 4.5 mg tablets.
Pemazyre 9 mg tablets.
Pemazyre 13.5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Pemazyre 4.5 mg tablets: Round (5.8 mm), white to off-white tablet debossed on one side with “I” and “4.5” on the reverse. Pemazyre 9 mg tablets: Oval (10 × 5 mm), white to off-white tablet debossed on one side with “I” and “9” on the reverse. Pemazyre 13.5 mg tablets: Round (8.5 mm), white to off-white tablet debossed on one side with “I” and “13.5” on the reverse. |
Pemazyre 4.5 mg tablets: Each tablet contains 4.5 mg of pemigatinib.
Pemazyre 9 mg tablets: Each tablet contains 9 mg of pemigatinib.
Pemazyre 13.5 mg tablets: Each tablet contains 13.5 mg of pemigatinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pemigatinib |
Pemigatinib is a kinase inhibitor of FGFR1, 2 and 3 which inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements. FGFR2 fusions/rearrangements are strong oncogenic drivers and are the most common FGFR alteration occurring, almost exclusively, in 10-16% of intrahepatic cholangiocarcinoma (CCA). |
| List of Excipients |
|---|
|
Microcrystalline cellulose (E-460) |
PVC/Al blister containing 14 tablets. Carton box containing 14 or 28 tablets.
Not all pack sizes may be marketed.
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Pemazyre 4.5 mg tablets:
EU/1/21/1535/001
EU/1/21/1535/002
Pemazyre 9 mg tablets:
EU/1/21/1535/003
EU/1/21/1535/004
Pemazyre 13.5 mg tablets:
EU/1/21/1535/005
EU/1/21/1535/006
Date of first authorisation: 26 March 2021
Date of latest renewal: 16 February 2022
| Drug | Countries | |
|---|---|---|
| PEMAZYRE | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, United Kingdom, United States |
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