Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, medinfoEMEA@takeda.com
FRUZAQLA 1 mg hard capsules.
FRUZAQLA 5 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. FRUZAQLA 1 mg hard capsules: Opaque hard gelatin capsule, size 3 (approximate length 16 mm), with a yellow cap and a white body imprinted with “HM013” over “1mg” in black ink. FRUZAQLA 5 mg hard capsules: Opaque hard gelatin capsule, size 1 (approximate length 19 mm), with a red cap and a white body imprinted with “HM013” over “5mg” in black ink. |
Each hard capsule contains 1 mg fruquintinib.
Excipients with known effect: Each 1 mg hard capsule contains 0.0247 mg of tartrazine (E102) and 0.0004 mg of sunset yellow FCF (E110) colourants.
Each hard capsule contains 5 mg fruquintinib.
Excipient with known effect: Each 5 mg hard capsule contains 0.1829 mg of Allura red AC (E129) colourant.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fruquintinib |
Fruquintinib is a selective tyrosine kinase inhibitor of VEGFR-1, -2, and -3 with antitumor effects resulting from suppression of tumour angiogenesis. |
| List of Excipients |
|---|
|
Capsule content: Maize starch Capsule shell (1 mg hard capsules only): Gelatin Capsule shell (5 mg hard capsules only): Gelatin Printing ink: Shellac (E904) |
High-density polyethylene (HDPE) bottle (45 mL) with polypropylene (PP) child-resistant closure and a HDPE desiccant cartridge containing silica gel. The desiccant must be kept inside the bottle.
Each bottle contains 21 hard capsules. Each bottle is packaged in a carton.
Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, medinfoEMEA@takeda.com
EU/1/24/1827/001
EU/1/24/1827/002
Date of first authorisation: 20 June 2024
| Drug | Countries | |
|---|---|---|
| FRUZAQLA | Austria, France, Lithuania, Romania, United States |
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