SALBUTAMOL CIPLA salbutamol 5 mg/2.5 mL (as sulfate) inhalation ampoules, Cipla Australia Pty Ltd, CON-894
Product name
SALBUTAMOL CIPLA salbutamol 5 mg/2.5 mL (as sulfate) inhalation ampoules
Sponsor name
Cipla Australia Pty Ltd
Batches
IA10660 and IA10661
Consent start
Consent no.
CON-894
Standard
Paragraph 9(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform to the requirements of paragraph 9(3)(a) of
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related
medicines (TGO 91), in that the labels do not include the name and quantity of
the active ingredient together on one line immediately below the medicine name
on the main label.
Conditions imposed
The labels to which this consent applies are those provided with the
application and email correspondence dated 26 October 2021.
Therapeutic product type
Prescription medicines