Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-4913/1
Trade NameDose FormStrengthIdentifier
ZithromaxCapsule250 mg
SponsorApplication dateRegistration situationClassification
Pfizer New Zealand Limited
P O Box 3998
AUCKLAND 1140
14/12/1990Approval lapsed
Approval date: 16/12/1993
Notification date: 3/1/2001
Prescription
 

Composition

ComponentIngredientManufacturer
capsuleActive 
 Azithromycin dihydrate 250 mgPfizer Pharmaceuticals LLC
Road #2, Km 58.2
Barceloneta 00617
Puerto Rico
  Pfizer Inc
Global Manufacturing Division
Eastern Point Road
Groton
Connecticut 06340
United States of America
  Pfizer Ireland Pharmaceuticals
Ringaskiddy API Plant
Ringaskiddy
Co. Cork
Ireland

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormPfizer Italia SrL
Strada Statale No 156
Km 47600
Borgo San Michele
Latina I-04010
Italy
PackingPfizer Italia SrL
Strada Statale No 156
Km 47600
Borgo San Michele
Latina I-04010
Italy
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Blister pack, 4, 6 capsules 24 months from date of manufacture stored at or below 30°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
19/1/2011Changed Medicine NotificationActive ingredient manufacturing process - Grade 1; Active ingredient specifications/test methods - Grade 4; Administrative fee (CMN)Granted 3/2/201128/1/2011 
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