IMUKIN interferon gamma-1b recombinant human 2 million IU (100 micrograms)/0.5mL injection vial, Link Medical Products Pty Ltd, CON-344
Product name
IMUKIN interferon gamma-1b recombinant human 2 million IU (100 micrograms)/0.5mL injection vial
Sponsor name
Link Medical Products Pty Ltd
Consent start
Consent no.
CON-344
Standard
Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product label does not comply with TGO 91 regarding the following
informationParagraphs 8(1)(a) and9(1)(a) the name of the medicine. The name of
the UK medicine (Immukin) is spelt differently to AU (Imukin).Paragraphs 8(1)(c)
and9(1)(c) the quantity or proportion of all active ingredients in the medicine.
The strength on the UK labelling (2x106 IU (0.1 mg)) is presented differently on
the AU labelling (2 million IU (100 microgram))Paragraph 8(1)(i) the name and
contact details of the sponsor or distributor. Name and address of the
Australian sponsor are not included on the labellingParagraph 9(3)(a) the name
and quantity of each active ingredient. The name of the active ingredient and
quantity of active ingredient are not in a cohesive unit on separate lines
immediately below the name of the medicine Paragraph 10(4)(j) the name of the
sponsor or distributor, or the registered trademark. Name of the sponsor is not
included on the vial labelSubparagraph 11(1)(a)(i) an expressed quantity for 1
microgram up to 999 micrograms. The strength of the active is presented as 0.1
mg and not 100 mcg
Conditions imposed
1. The ordered UK stock to cover the medicine shortage is identical to the
Australian registered product.2. There will be a sticker including Link's
details attached to the product labels for physician/patient contact.3.
Arrangements are in place to include a health care professional letter
(identical to that provided to the TGA on 26 November 2019) with IMUKIN
dispensed by relevant pharmacies.
Therapeutic product type
Prescription medicines