ESTALIS SEQUI 50/140 patches sachet composite pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-696
Product name
ESTALIS SEQUI 50/140 patches sachet composite pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Batches
Batch number 88943, Units 9,800
Consent start
Consent no.
CON-696
Standard
Paragraphs 8(1)(b) and 9(1)(b), subsection 9(2), paragraph 9(3)(a) and subparagraph 10(13)(a)(vi) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
Cartons Section 8 - Information to be included on the main label (1)(b) the name
of the active ingredient estradiol is spelt as 'oestradiol', that is, the
previous spelling prior to the harmonisation of medicine ingredient names, and
which ceased to be the Australian Approved Name on 30 April 2020. Section 9 -
Information to be included on the main carton label (1)(b) the name of the
active ingredient estradiol is spelt as 'oestradiol', that is, the previous
spelling prior to the harmonisation of medicine ingredient names, and which
ceased to be the Australian Approved Name on 30 April 2020. (2) The name of the
medicine on the main label must be presented in a continuous, uninterrupted
manner and not be broken up by additional information or background text. (3)
The name of the medicine and the name(s) of active ingredient(s) on the main
label must (a) appear as a cohesive unit by the placing of the name and quantity
of each active ingredient together on separate lines of text. Pouches Subsection
10(13) - Individually wrapped medicines (a)(vi) the name of the active
ingredient estradiol is spelt as 'oestradiol', that is, the previous spelling
prior to the harmonisation of medicine ingredient names, and which ceased to be
the Australian Approved Name on 30 April 2020. In addition, the labels differ
from the currently approved TGO 91 compliant labels as minor editorial changes
have been made.
Conditions imposed
The carton labels are over-stickered with the correct number and
'New formulation' statement.
A 'Dear Healthcare Provider' letter identical to that provided to the TGA
with your letters of application (e004996 (0010) and (0011)) will be supplied
with each affected batch outlining the reasons for the different labelling.
Therapeutic product type
Prescription medicines