ADRENALINE-LINK 1:10,000 1 mg/10 mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe, Link Pharmaceuticals, CON-220
Product name
ADRENALINE-LINK 1:10,000 1 mg/10 mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe
Sponsor name
Link Pharmaceuticals
Consent start
Consent no.
CON-220
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
Do not bear the Australian name of the medicine (paragraphs 8(1)(a), 9(1)(a) and
10(4)(c) of TGO 91). Do not have the name of the medicine and the name and
quantity of the active ingredient displayed as a 'cohesive unit' on the main
label as detailed in subections 9(2) and 9(3) of TGO 91. Do not bear the
approved route of administration (paragraphs 8(1)(m), 9(1)(f) and 10(4)(k) of
TGO 91). Do not bear the statements 'Use in one patient on one occasion only.
Contains no antimicrobial preservative' (paragraph 10(3)(b) of TGO 91). Do not
have the name of the medicine displayed on at least three non-opposing sides of
the carton (paragraph 8(1)(o) of TGO 91). The UK carton label does not express
the name and quantity of each excipient in the medicine (paragraph 10(3)(a) of
TGO 91). The label for the prefilled syringe does not bear the name or
registered trademark of the Australian sponsor or the Australian distributor
(paragraph 10(4)(j) of TGO 91).
Conditions imposed
A 'Dear Healthcare Professional letter identical to that provided to the
Therapeutic Goods Administration on 25 October 2017 will be supplied with the
affected product, informing that the product is packaged with UK labelling and
advising the Healthcare Professionals of the differences between the UK
labelling, including packaging insert, and the Australian approved product. In
particular, that this product is for intravenous use only.
The labels (i.e. UK carton, carton closure and prefilled syringe labels)
to which this consent applies are those provided with the letter of application,
where the carton label includes an over-sticker that details the Australian
sponsor's name and contact details (address, phone, fax and email), and the AUST
R number.
Therapeutic product type
Prescription medicines