Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-6401 |
Trade Name | Dose Form | Strength | Identifier |
Tamiflu | Capsule | 75 mg | |
Sponsor | Application date | Registration situation | Classification |
Roche Products (NZ) Ltd P O Box 109113 Newmarket Auckland 1149 | 10/6/1999 | Consent given Approval date: 27/1/2000 | Restricted |
Composition
Component | Ingredient | Manufacturer |
capsule | Active | |
Oseltamivir phosphate 98.5mg equivalent to 75 mg oseltamivir | Patheon API Inc. 6173 E Old Marion Highway Florence South Carolina 29506-9330 UNITED STATES OF AMERICA | |
F Hoffmann-La Roche Ltd Grenzacherstrasse 124 Basel CH-4070 SWITZERLAND | ||
Excipient | ||
Croscarmellose sodium | ||
Gelatin | ||
Iron oxide black | ||
Iron oxide red | ||
Iron oxide yellow | ||
Opacode blue S-1-4118 | ||
Povidone | ||
Purified talc | ||
Sodium stearyl fumarate | ||
Starch | ||
Titanium dioxide | ||
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Delpharm Milano S.r.L Via Carnevale 1 Segrate Milan 20054 ITALY |
F Hoffmann-La Roche Ltd Betriebsstandort Analytiklabor Bau 250 Kaiseraugst CH-4303 SWITZERLAND | |
F Hoffmann-La Roche Ltd Grenzacherstrasse 124 Basel CH-4070 SWITZERLAND | |
Manufacture of Final Dose Form | Cenexi SAS 52 rue Marcel et Jacques Gaucher Fontenay-sous-Bois 94120 FRANCE |
Delpharm Milano S.r.L Via Carnevale 1 Segrate Milan 20054 ITALY | |
Packing | Delpharm Milano S.r.L Via Carnevale 1 Segrate Milan 20054 ITALY |
F Hoffmann-La Roche Ltd Betriebsstatten Kaiseraugst Wurmisweg Kaiseraugst CH-4303 SWITZERLAND | |
Secondary Packaging | Delpharm Milano S.r.L Via Carnevale 1 Segrate Milan 20054 ITALY |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
NZ Site of Product Release | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVDC/PE/PVC-Al | 10 capsules | 10 years from date of manufacture stored at or below 25°C |
Indications
· Tamiflu is indicated for the treatment of influenza in adults and children 2 weeks of age and older who have been symptomatic for no more than 2 days.
· Tamiflu is indicated for the prophylaxis of influenza in adults and children 1 year of age and older.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
31/5/2021 | Changed Medicine Notification | Active ingredient manufacturing process - Grade 1; Administrative fee (CMN) | Granted 29/6/2021 | 1/6/2021 |