FASENRA benralizumab 30 mg in 1 mL solution for injection prefilled syringe, AstraZeneca Pty Ltd, CON-293
Product name
FASENRA benralizumab 30 mg in 1 mL solution for injection prefilled syringe
Sponsor name
AstraZeneca Pty Ltd
Batches
024E 17-2J
Consent start
Consent no.
CON-293
Standard
Therapeutic Goods Order No.91 '“ Standard for labels of prescription and related medicines.
Non-compliance with standard
The product label does not comply with the following Therapeutic Goods Order
No.91 requirements#58; 7(2)(d)(i)#58; Does not have registration number
8(1)(i)#58; Does not have name and contact details of the sponsor 9(3)(a)(i)#58;
The location of the active ingredient name and quantity in relation to the
tradename 10(3)(a)(i)#58; Does not have the quantity of all excipients and the
name of one excipient 10(3)(b)#58; Does not have the statement quot;Use in one
patient on one occasion only. Contains no antimicrobial preservative.quot;
11(2)(f)(v)#58; The expression of the active ingredient quantity on the main
panel 11(5)(iii)#58; Does not have the required storage conditions statements
Conditions imposed
The labels to which this consent applies are those provided for this
specific batch with UK labels.
Arrangements are in place to include a health care professional letter with
FASENRA dispensed by iCare Pharmacy or other relevant pharmacies.
Therapeutic product type
Prescription medicines