Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule, Pfizer Australia Pty Ltd, CON-877
Product name
Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-877
Standard
Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform with the requirements of Paragraph 11(2)(f) of
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related
medicines (TGO 91) in that the carton label for the product states the strength
of the active ingredient as 10mmol (0.75g) in 10mL.
Conditions imposed
The carton label to which this consent applies is that provided with the
application in the email correspondence from Pfizer Australia Pty Ltd to the
TGA dated 8th October 2021.
Therapeutic product type
Prescription medicines