Brineura

Brineura Warnings and Precautions

• Administration-related reactions: Reactions may occur due to the intraventricular device and infusion procedure, including device-related complications such as infection.
• Hypersensitivity reactions: Fever, rash, and other allergic-type reactions have been reported; patients should be monitored during and after infusion.
• ECG changes: Brineura may cause changes in cardiac electrical activity; some patients may require ECG monitoring.
• Requires specialized administration: Must only be given by, or under the supervision of, a physician experienced in intraventricular access device use, in a setting equipped to manage the procedure.

How to Access Brineura in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant, frozen cold-chain conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Brineura to India?

Brineura (cerliponase alfa) injection may be imported in the patient's name only, by patients or government hospitals, in line with India's import regulations for unapproved medicines. The following documentation is required:

• A valid prescription from a qualified pediatric neurologist
• The patient's diagnostic reports, including confirmation of CLN2 disease (TPP1 deficiency)
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Brineura available in India?

Brineura (cerliponase alfa injection) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Brineura is not commercially marketed in India.

However, patients in India can legally access Brineura through the Named Patient Program (NPP) — an import provision that allows patients to receive medicines approved in other countries but not yet marketed in India, under a doctor's prescription and proper regulatory documentation.

Brineura received US FDA approval in April 2017 for slowing the loss of ambulation in pediatric patients with CLN2 disease, ensuring full transparency throughout the process.

Brineura can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others.

Sourcing & Delivery of Brineura

Brineura is sourced directly from authorized channels in the country of origin and shipped to India under GDP-compliant, frozen cold-chain logistics to preserve product integrity from dispatch to delivery.

• Frozen cold-chain shipping maintained at -25°C to -15°C throughout transit
• Real-time shipment tracking and delivery updates
• Delivery coordinated directly with the patient, family, or treating hospital

Availability of Brineura Across Major Cities in India

Named Patient Program supports access to Brineura for pediatric patients with CLN2 disease across major cities in India, coordinating documentation, sourcing, and frozen cold-chain delivery with treating specialists.

Mumbai

Patients in Mumbai can access Brineura through NPP with support from treating pediatric neurologists at the city's leading centers.

Delhi

In Delhi, NPP coordinates with hospitals and specialty pediatric neurology clinics to facilitate timely access to Brineura for eligible CLN2 patients.

Bangalore

Bangalore's pediatric neurology and genetics centers work with NPP to support patients requiring Brineura.

Chennai

Patients in Chennai can access Brineura through NPP, with coordination between treating doctors and the program's regulatory and logistics team.

Hyderabad

Hyderabad's pediatric neurology and genetic testing centers support diagnosis and access coordination for Brineura through NPP.

Kolkata

NPP facilitates access to Brineura for patients in Kolkata under the guidance of treating pediatric neurologists.

Pune

Patients in Pune can access Brineura through NPP with prescription-based coordination and frozen cold-chain delivery support.

Ahmedabad

NPP supports access to Brineura for patients in Ahmedabad, working directly with treating specialists.

Kochi

Patients in Kochi and across Kerala can access Brineura through NPP's regulated import pathway.

Chandigarh

NPP coordinates access to Brineura for patients in Chandigarh and the surrounding region.

Jaipur

Patients in Jaipur can access Brineura through NPP with support from treating pediatric neurologists.

Lucknow

NPP facilitates access to Brineura for CLN2 patients in Lucknow and across Uttar Pradesh.

Bhubaneswar

Patients in Bhubaneswar can access Brineura through NPP's coordinated import and delivery process.

Guwahati

NPP supports access to Brineura for patients in Guwahati and across the Northeast region.

NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.