Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-6401
Trade NameDose FormStrengthIdentifier
TamifluCapsule75 mg
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
10/6/1999Consent given
Approval date: 27/1/2000
Restricted
 

Composition

ComponentIngredientManufacturer
capsuleActive 
 Oseltamivir phosphate 98.5 mg equivalent to 75 mg oseltamivirPatheon 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 stepManufacturer
Finished Product TestingDelpharm Milano S.r.L
Via Carnevale 1
Segrate
Milan 20090
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
 Labor LS SE & Co.KG
Mangelsfeld 4, 5 & 6
Bad Bocklet
Grossenbrach 97708
Germany
 Roche Pharma AG
Emil-Barell Strasse 1
Grenzach-Wyhlen D-79639
Germany
Manufacture of Final Dose FormCatalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Schorndorf D-73614
Germany
 Cenexi SAS
52 rue Marcel et Jacques Gaucher
Fontenay-sous-Bois 94120
France
 Delpharm Milano S.r.L
Via Carnevale 1
Segrate
Milan 20090
Italy
PackingCatalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Schorndorf D-73614
Germany
 F Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
Switzerland
Secondary PackagingPharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Blister pack, PVDC/PE/PVC-Al10 capsules10 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 DateApplication TypeChange(s)StatusPayment DatePriority
28/5/2020CMN 24(5)Contraindications, warnings and precautions; Administrative fee (CMN)Initial evaluation17/6/2020 
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