CSL ZOSTER IMMUNOGLOBULIN VF (human) 200IU injection vial, CSL Behring Australia, CON-404
Product name
CSL ZOSTER IMMUNOGLOBULIN VF (human) 200IU injection vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-404
Standard
Paragraph 8(1)(c) and subparagraphs 10(3)(a)(i) and 11(2)(f)(v) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
1.The product's carton does not express the quantity or proportion of all active
ingredients as the weight in the stated volume of fill in the container.2.The
product's carton does not express the quantity of the excipient as the mass in
the stated volume of fill in the container.3.The product's carton does not state
the weight of the active ingredient in the stated volume of fill of the
injection in the container.
Conditions imposed
The carton exempted from TGO 91 is identical to that approved by the
TherapeuticGoodsAdministrationand presented with the submission
Therapeutic product type
Prescription medicines