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CSL TETANUS IMMUNOGLOBULIN-VF (human) for intravenous use 4000 IU injection vial, CSL Behring Australia, CON-400
Product name
CSL TETANUS IMMUNOGLOBULIN-VF (human) for intravenous use 4000 IU injection vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-400
Duration
The consent is effective from the 29th April 2020 until further notice.
Standard
Paragraph 8(1)(c) and subparagraphs 10(3)(a)(i), 11(2)(f)(v) iin 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 container3. The product’s carton
does not state the weightof 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 waspresented with thesubmission.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines