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Palivizumab

Synagis · ATC code J06BD01

Key facts
Active substance
Palivizumab
Drug class
Immunoglobulin therapy
ATC code
J06BD01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Synagis 50 mg/0.5 ml solution for injection / Synagis 100 mg/1 ml solution for injection
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-29

Key facts

Palivizumab (Synagis) is a humanised monoclonal antibody against respiratory syncytial virus (RSV). It is given intramuscularly to prevent serious RSV disease in high-risk children.

What it is used for

  • Prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk:
  • Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
  • Children less than 2 years of age treated for bronchopulmonary dysplasia within the last 6 months, or with haemodynamically significant congenital heart disease.

Dosing

  • 15 mg/kg body weight once a month during the RSV season; volume in ml = weight in kg × 0.15.
  • Give the first dose before the RSV season where possible; children hospitalised with RSV should continue monthly doses.
  • After cardiac bypass, give 15 mg/kg as soon as stable after surgery, then resume monthly.
  • Intramuscular, preferably anterolateral thigh; volumes over 1 ml are given as a divided dose.

Contraindications

  • Hypersensitivity to the active substance, any of the excipients or other humanised monoclonal antibodies.

Important warnings

  • Allergic reactions including very rare anaphylaxis, sometimes fatal; treatment for anaphylaxis should be available immediately.
  • A moderate to severe acute infection or febrile illness may warrant delaying the dose.
  • Caution in thrombocytopenia or any coagulation disorder.
  • Record the product name and batch number.

Side effects

  • Common: fever, rash and injection site reaction.
  • Most serious: anaphylaxis and other acute hypersensitivity reactions.

Interactions

  • No formal interaction studies; palivizumab is not expected to interfere with the immune response to vaccines.

Pregnancy and breastfeeding

  • Not relevant: Synagis is not indicated for use in adults.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SynagisAstraZeneca AB · EMEA/H/C/000257

Source: European Medicines Agency (EMA), product information

Turkey

  • SynagisASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Synagis
Liechtenstein
Synagis
Norway
Synagis

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Synagis – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC J06BD.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.