CSL HEPATITIS B IMMUNOGLOBULIN VF (human) 400IU injection vial, CSL Behring Australia, CON-405
Product name
CSL HEPATITIS B IMMUNOGLOBULIN VF (human) 400IU injection vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-405
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
TherapeuticGoodsAdministration and presented with thesubmission.
Therapeutic product type
Prescription medicines