CSL CMV IMMUNOGLOBULIN-VF (human) 1.5 million units/vial injection vial, CSL Behring Australia, CON-401
Product name
CSL CMV IMMUNOGLOBULIN-VF (human) 1.5 million units/vial injection vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-401
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 vial label and carton do 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 vial label and carton do not express the quantity of
the excipient as the mass in the stated volume of fill in the container.3. The
product's vial label and carton do not state the weight of the active ingredient
in the stated volume of fill of the injection in the container.
Conditions imposed
The vial label and carton exempted from TGO 91 are identical to those approved
by the TherapeuticGoodsAdministration and presented with this submission.
Therapeutic product type
Prescription medicines