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Retavibart

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Ready to proceed? Start a request for Retavibart on our secure patient portal to submit your prescription, upload documents and track your approval status.

Retavibart

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Retavibart
Generic Name (API): Retavibart
Dosage Form & Strength: 120 mg
Route: Intramuscular (IM) injection
Drug Class: Long-acting anti-RSV (Pre-F) fully human monoclonal antibody

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Retavibart Used For?

Retavibart is a long-acting antibody injection that protects babies against serious chest infections caused by respiratory syncytial virus (RSV). It was developed by Zhuhai Trinomab Pharmaceutical Co., Ltd. and is sold in China as 新多妥 (Xinduotuo). In research it was called TNM001.

China's National Medical Products Administration (NMPA) approved it in September 2026, after a priority review. It is approved for:

  • Prevention of RSV lower respiratory tract infection (such as bronchiolitis and pneumonia)
  • In newborns and infants who are entering, or are born during, their first RSV season

It is a prescription infection-prevention medicine and should be given under the care of a paediatrician or neonatologist.

How It Works

RSV is a common seasonal virus. Most infants catch it in their first year, and in young babies it can spread to the lungs and lead to hospital care. Retavibart is a fully human monoclonal antibody, isolated from natural human immune cells, that locks on to the pre-fusion (Pre-F) form of the virus's F protein. This stops the virus from fusing with cells in the airways. Instead of waiting for the baby's own immune system to respond, the injection gives ready-made protection straight away. The company reports protection data for up to 270 days (about nine months) from one dose.

What the Trials Showed

A phase 2b trial, published as a conference abstract in Open Forum Infectious Diseases (2026), included 751 infants with a median age of 2.5 months, including some born early or with heart disease. Compared with a placebo injection, one dose of retavibart cut lab-confirmed RSV chest infections needing medical care by 66.2% and RSV hospital admissions by 82.3% over about five months. In the 92 higher-risk babies, the reductions were 91.1% and 93.5%.

Trinomab reports that its phase 3 trial in healthy full-term and late-preterm infants also showed a significant fall in RSV chest infections, especially severe ones. Full phase 3 numbers had not been published in a journal at the time of writing.

Recommended Dosage

  • 120 mg, as one injection into the muscle of the outer thigh
  • One fixed dose for every baby, with no weight-based calculation
  • For babies entering their first RSV season, or born during it

The paediatrician decides the right timing for your baby based on the label and local RSV patterns.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Overall safety: in the phase 2b trial, the rates of side effects and of serious side effects were similar with retavibart and with placebo. No baby died and none left the trial because of a side effect. Babies were followed for safety for up to 240 days after the injection.

  • After the injection: the doctor will usually ask you to wait a short while so the baby can be observed.
  • Allergies: tell the doctor about any earlier reaction to an injection, and seek help at once if the baby develops swelling, a rash or trouble breathing after the dose.
  • Not a treatment for active illness: it is a preventive injection. A baby who already has a cough, fever or breathing difficulty must be seen by a doctor straight away.

Limits of the evidence: the approved use is for infants in their first RSV season. Detailed phase 3 safety figures were not yet published in a journal, so the full Chinese prescribing information should guide use.

How to Access Retavibart 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, 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 Retavibart to India?

The injection can be imported only in the patient's name, by the patient's family or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified paediatrician or neonatologist
  • The baby's birth details and relevant medical notes
  • A parent's ID proof (issued by the Government of India) and the baby's birth certificate where available

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit. Because RSV seasons are predictable, we suggest starting the request a few weeks before the planned injection date.

Is Retavibart available in India?

No. It is approved only in China. It has no CDSCO approval and is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it.

Families can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. We also arrange other preventive anti-infective imports, such as Prevymis.

It 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 — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. It is stored and shipped as directed on the pack, using temperature-controlled shipping to the treating hospital or clinic. We time each delivery to the baby's planned injection date. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Families across India can access this medicine through regulated import pathways, with delivery arranged to the treating hospital or clinic on a valid paediatrician's prescription.

Delhi

Paediatricians and neonatal units in Delhi can send us the prescription; our New Delhi dispatch point keeps transit short.

Mumbai

We plan delivery around the baby's injection appointment so the dose is ready on the day.

Bangalore

Parents and paediatricians in Bangalore receive a written quote before anything is ordered.

Chennai

Deliveries go directly to the hospital or clinic that will give the injection.

Hyderabad

Neonatal units in Hyderabad can request it for a named baby, with updates at each step.

Kolkata

Shipments to Kolkata and the eastern states travel under controlled temperature conditions.

Pune

Families in Pune can use the same documented import route through their paediatrician.

Ahmedabad

The paediatrician can share the prescription and birth details with us to begin the import.

Vellore

Babies cared for at hospitals in Vellore can have the injection delivered straight to the hospital.

Chandigarh

Serves families from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.

Lucknow

We coordinate delivery to children's hospitals and clinics across Uttar Pradesh.

Kochi

Families across Kerala can receive the injection at their hospital in Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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