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Médicament Spinraza.pdf

spinraza-epar-summary-public_en.pdf
Preview of médicament Spinraza
🔗 Source: ema.europa.eu
📊 Size: 78 KB
👤 Author: CHMP
⬇️ Downloads: 122

Summary

Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of muscles. It contains the active substance nusinersen and is given by intrathecal injection into the spine. The recommended dose is 12 mg, given as soon as possible after diagnosis, followed by 3 more doses after 2, 4, and 9 weeks, and then one dose every 4 months thereafter. Spinraza works by enabling the SMN2 gene to produce full-length protein, replacing the missing protein and relieving symptoms. Studies have shown that Spinraza improves movement and survival in babies and children with SMA. Common side effects include headache, back pain, and vomiting. The European Medicines Agency approved Spinraza due to its clinically meaningful improvements in young children with SMA, and the company will complete ongoing studies of its long-term safety and effectiveness.

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Description

Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of muscles.

Technical Information

  • File Format: PDF
  • File Size: 78 KB
  • Pages: 3
  • Language: EN
  • Author: CHMP
  • Total Downloads: 122
  • Last Updated: 6 hours ago

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This PDF document about médicament Spinraza provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into médicament Spinraza.

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