Regulatory PathRegulatory requirements compared

Active substance

Zanamivir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RELENZA 5MG POWDER FOR INHALATION5 mgInhalation powder · Inhalation use1 Multidose containerSAR 60.95NCE · PrescriptionGlaxo Saudi Arabia LtdValid
Indications — CHI Daman Drug Formulary

SICKLE CELL DISEASE - INFLUENZA; TRAVEL RELATED INFECTIONS-INFLUENZA PROPHYLAXIS; TRAVEL RELATED INFECTIONS-TREATMENT

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
RELENZA5MGpowder · inhalationGLAXOSMITHKLINEPrescription26 Jul 1999

EMA European Union — centrally authorised medicines

Dectova GlaxoSmithKline Trading Services Limited · Authorised · authorised 26 Apr 2019 · ATC J05AH01

Therapeutic indication (EMA)

Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ?6 months) when: The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RELENZA022408635 MG / ACTPOWDER · INHALATION; ORALGLAXOSMITHKLINE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffZanamivir 5mg inhalation powder blisters with device£16.3620 blister1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for zanamivir →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.