Regulatory PathRegulatory requirements compared

Active substance

Oseltamivir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OSELTA 75MG CAPSULES75 mgCapsule · Oral use10 BlisterSAR 79.85Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
Oselow75 mgCapsule · Oral use10 BlisterSAR 71.85Generic · PrescriptionBoston Oncology ArabiaValid
Oseltamivir PPI75 mgCapsule · Oral use10 BlisterSAR 28.90Generic · PrescriptionPharma Pharmaceutical Industries & Biological ProductsValid
Oseltamivir PPI45 mgCapsule · Oral use10 BlisterSAR 16.15Generic · PrescriptionPharma Pharmaceutical Industries & Biological ProductsValid
Oseltamivir PPI30 mgCapsule · Oral use10 BlisterSAR 15.60Generic · PrescriptionPharma Pharmaceutical Industries & Biological ProductsValid
TABUFLU 75MG CAPSULES75 mgCapsule · Oral use10 BlisterSAR 75.85Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
TAMIFLU 75 MG CAPSULE75 mgCapsule · Oral use10 BlisterSAR 79.85NCE · PrescriptionROCHEValid
TAMIFLU 12MG-ML ORAL SUSPENSION12 mg/mlOromucosal suspension · Oral use1 BottleSAR 112.05NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

COMMUNITY ACQUIRED PNEUMONEA; SICKLE CELL DISEASE - INFLUENZA; TRAVEL RELATED INFECTIONS-INFLUENZA PROPHYLAXIS; TRAVEL RELATED INFECTIONS-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
TAMIFLUEQ 75MG BASEcapsule · oralROCHEPrescription27 Oct 1999
TAMIFLUEQ 6MG BASE/MLfor suspension · oralROCHEPrescription14 Dec 2000
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralNATCOPrescription3 Aug 2016
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralZYDUS PHARMSPrescription24 Feb 2017
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralAMNEAL PHARMSPrescription17 May 2017
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralMACLEODS PHARMSPrescription14 Sep 2017
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralZYDUS PHARMSPrescription14 Sep 2017
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralALVOGENPrescription31 Oct 2017
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralLUPINPrescription9 Jan 2018
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralLUPINPrescription20 Feb 2018
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralHETERO LABS LTD IIIPrescription23 Feb 2018
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralSTRIDES PHARMAPrescription8 Jun 2018
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralTEVA PHARMS USAPrescription27 Feb 2019
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralALEMBICPrescription24 Jun 2019
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralSUNSHINEPrescription4 Mar 2020
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralMSNPrescription20 May 2020
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralAJANTA PHARMA LTDPrescription27 May 2020
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralINVAGEN PHARMSPrescription30 Aug 2021
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralEPIC PHARMA LLCPrescription1 Oct 2021
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralSUNSHINEPrescription5 Jan 2022
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralSTRIDES PHARMAPrescription13 Jan 2022
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralHETERO LABS LTD VPrescription28 Mar 2022
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralMSNPrescription2 May 2022
OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLfor suspension · oralEPIC PHARMA LLCPrescription14 Feb 2023
OSELTAMIVIR PHOSPHATEEQ 30MG BASE; EQ 45MG BASE; EQ 75MG BASEcapsule · oralINVAGEN PHARMSPrescription3 Oct 2023

16 more — full table

EMA European Union — centrally authorised medicines

Tamiflu Roche Registration GmbH · Authorised · authorised 20 Jun 2002 · ATC J05AH02

Therapeutic indication (EMA)

Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.

Ebilfumin Actavis Group PTC ehf · Authorised · authorised 22 May 2014 · ATC J05AH02

Therapeutic indication (EMA)

Treatment of influenzaIn patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child. Prevention of influenzaPost-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2 of the SmPC). Ebilfumin is not a substitute for influenza vaccination.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP OSELTAMIVIR0249740930 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP OSELTAMIVIR0249742575 MGCAPSULE · ORALJAMP PHARMA CORPORATION
MINT-OSELTAMIVIR0249744130 MGCAPSULE · ORALMINT PHARMACEUTICALS INC
MINT-OSELTAMIVIR0249747675 MGCAPSULE · ORALMINT PHARMACEUTICALS INC
NAT-OSELTAMIVIR0245798975 MGCAPSULE · ORALNATCO PHARMA (CANADA) INC
NAT-OSELTAMIVIR0247263530 MGCAPSULE · ORALNATCO PHARMA (CANADA) INC
NAT-OSELTAMIVIR0247264345 MGCAPSULE · ORALNATCO PHARMA (CANADA) INC
NAT-OSELTAMIVIR024998946 MG / MLPOWDER FOR SUSPENSION · ORALNATCO PHARMA (CANADA) INC
SANDOZ OSELTAMIVIR0250400630 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
SANDOZ OSELTAMIVIR0250401445 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
SANDOZ OSELTAMIVIR0250402275 MGCAPSULE · ORALSANDOZ CANADA INCORPORATED
TAMIFLU0224147275 MGCAPSULE · ORALHOFFMANN-LA ROCHE LIMITED
TAMIFLU0230484830 MGCAPSULE · ORALHOFFMANN-LA ROCHE LIMITED
TAMIFLU0230485645 MGCAPSULE · ORALHOFFMANN-LA ROCHE LIMITED
TAMIFLU023818426 MG / MLPOWDER FOR SUSPENSION · ORALHOFFMANN-LA ROCHE LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOSELTAMIVIR 6 MG/ML SUSPENSION$0.14964per ML30 Sep 2026
US NADACOSELTAMIVIR PHOS 30 MG CAPSULE$0.67955per EA23 Sep 2026
US NADACOSELTAMIVIR PHOS 45 MG CAPSULE$0.7872per EA23 Sep 2026
US NADACOSELTAMIVIR PHOS 75 MG CAPSULE$0.79621per EA23 Sep 2026
US NADACTAMIFLU 6 MG/ML SUSPENSION$2.43293per ML18 Feb 2026
US NADACTAMIFLU 75 MG CAPSULE$14.51856per EA18 Mar 2026
NHS Drug TariffOseltamivir 30mg capsules£7.7110 capsule1 Oct 2026
NHS Drug TariffOseltamivir 45mg capsules£15.4110 capsule1 Oct 2026
NHS Drug TariffOseltamivir 6mg/ml oral suspension sugar free£10.2750 ml1 Oct 2026
NHS Drug TariffOseltamivir 75mg capsules£15.4110 capsule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.4.3. Other antivirals · complementary
    Influenza due to identified seasonal influenza virus
    Oral > Liquid: 6 mg per mL (as phosphate) powder for oral liquid (EMLc) | Oral > Solid: 30 mg capsule (as phosphate); 45 mg capsule (as phosphate); 75 mg capsule (as phosphate)

Safety signals and safety-related labeling changes

All safety entries for oseltamivir →

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.