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Summary Of Product Characteristics (SmPC).pdf

pemazyre-epar-product-information_en.pdf
Preview of Summary of Product Characteristics (SmPC)
🔗 Source: ema.europa.eu
📊 Size: 450 KB
👤 Author: CHMP
⬇️ Downloads: 71

Summary

Pemazyre is a medicinal product for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. It is available in 4.5 mg, 9 mg, and 13.5 mg tablets. The recommended dose is 13.5 mg taken once daily for 14 days followed by 7 days off therapy. Dose adjustments may be necessary due to hyperphosphataemia, serous retinal detachment, or concomitant use of strong CYP3A4 inhibitors. The product is subject to additional monitoring, and healthcare professionals are asked to report any suspected adverse reactions.

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Description

Pemazyre is a medicinal product for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2...

Technical Information

  • File Format: PDF
  • File Size: 450 KB
  • Pages: 36
  • Language: EN
  • Author: CHMP
  • Total Downloads: 71
  • Last Updated: 1 week ago

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