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EMA Approves Tyruko For Multiple Sclerosis Treatment.pdf

chmp-summary-positive-opinion-tyruko_en.pdf
Preview of EMA Approves Tyruko for Multiple Sclerosis Treatment
🔗 Source: ema.europa.eu
📊 Size: 146 KB
👤 Author: CHMP
⬇️ Downloads: 186

Summary

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on July 20, 2023, recommending the granting of a marketing authorization for Tyruko, a biosimilar medicinal product intended for the treatment of multiple sclerosis.

Product Information:

Active substance: Natalizumab (ATC code: L04AA23)
 Formulation: 300 mg concentrate for solution for infusion
Indication: Single disease-modifying therapy for adults with highly active relapsing-remitting multiple sclerosis (RRMS).

Target Patient Groups:

Patients with highly active RRMS despite adequate treatment with at least one disease-modifying therapy.
Patients with rapidly evolving severe RRMS characterized by:
 2 or more disabling relapses in one year
Gadolinium enhancing lesions on brain MRI
Significant increase in T2 lesion load compared to a recent MRI

Key Points:

Tyruko is highly similar to the reference product Tysabri (natalizumab), which has been authorized in the EU since 2006.
 Clinical data demonstrate comparable quality, safety, and efficacy between Tyruko and Tysabri.
* Prescribing should be done by specialized physicians with experience in neurological conditions, in centers equipped for timely MRI access.

The full summary of product characteristics (SmPC), including detailed recommendations, will be published in the European public assessment report (EPAR) after marketing authorization is granted by the European Commission.

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Description

The European Medicines Agency (EMA) has recommended the approval of Tyruko (natalizumab) for treating multiple sclerosis, manufactured by Sandoz GmbH. Available as a 300mg concentrate for infusion, Tyruko exhibits selective immunosuppressive properties. For inquiries, visit www.ema.europa.eu/contact or call +31 (0)88 781 6000.

Technical Information

  • File Format: PDF
  • File Size: 146 KB
  • Pages: 2
  • Language: EN
  • Author: CHMP
  • Total Downloads: 186
  • Last Updated: 7 days ago

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