Brineura

Named-patient access overview. Brineura is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.

Quick orientation

Brineura (cerliponase alfa) is a recombinant human tripeptidyl peptidase-1 enzyme replacement therapy developed by BioMarin. It is approved by the US FDA for late infantile neuronal ceroid lipofuscinosis type 2 (CLN2 disease, TPP1 deficiency) in patients 3 years and older to slow loss of ambulation. The standard regimen is 300 mg every 14 days via implanted intracerebroventricular reservoir over approximately 4.5 hours. Brineura is available in the global pharmaceutical supply chain in 300 mg per 10 mL vial for intracerebroventricular infusion.

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How Reserve Meds coordinates Brineura

  1. Patient or treating physician submits an intake at the patient portal.
  2. Reserve Meds clinical team verifies appropriateness for the patient and destination country.
  3. Treating physician issues prescription and clinical justification.
  4. Country-specific named-patient documentation is prepared.
  5. Brineura is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
  6. Shipment is coordinated to the patient's physician or hospital pharmacy with appropriate handling.

Access by country

Reserve Meds publishes a detailed country deep-dive for Brineura in every market we coordinate. Each page below covers the destination-country regulatory pathway, real costs, indicative timelines, physician-credential requirements, and handling notes. Tap any country to read the full deep-dive.

Start a request for Brineura

Submit a 60-second intake. The clinical team will follow up within 24 hours with case-specific feasibility, timeline, and a formal quote.

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