NUCALA mepolizumab 100 mg solution for injection in pre-filled syringe, GlaxoSmithKline Australia Pty Ltd, CON-353
Product name
NUCALA mepolizumab 100 mg solution for injection in pre-filled syringe
Sponsor name
GlaxoSmithKline Australia Pty Ltd
Batches
8N5G
Consent start
Consent no.
CON-353
Standard
Subsection 8(2), Paragraphs 8(1)(h), 8(1)(i), 10(3)(a), 10(3)(b) and subparagraph 9(3)(a)(i) in the Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines (TGO No. 91)
Non-compliance with standard
Cartons8(1)(h) The medicine's storage conditions ('Store in a refrigerator') do
not include the permitted temperature range in which it should be stored (i.e.
2°C to 8°C). The cartons do not include the storage instructions of 'Store in
the original packaging to protect from light'.8(1)(i) The name and details of
the Australian sponsor are not included.8(2) The cartons do not include a
specific space for a dispensing label, however, there is sufficient space on the
back panel for a dispensing label to be attached to the carton.9(3)(a)(i) The
name of the medicine and the name of the active ingredients on the main label
does not appear as a cohesive unit. The active ingredient name is not included
immediately below the name of the medicine.10(3)(a) The quantity of each
ingredient is not included.10(3)(b) The cartons include a statement regarding
single use, however, do not include a statement regarding antimicrobial
preservatives.The cartons do not include details regarding the availability of
the Australian Consumer Medicine Information (CMI).Syringe and pen labelsThe
Australian CMI and Instructions for Use are not included as package inserts.
Conditions imposed
The NUCALA pre-filled pen and pre-filled syringe in UK packaging will be
over-stickered with the relevant number(s) in order to comply with
paragraph 19D(3)(c) of the Act to include the registration number (AUST-R) (and
in accordance with the requirements of regulation 15 of the Therapeutic Goods
Regulations 1990).
The supply of NUCALA pre-filled pen and pre-filled syringe in UK
packaging will only occur as part of the Product Familiarisation Program (PFP)
aimed at educating healthcare professionals (HCPs) with the new presentations
before they become more widely available. The PFP will be governed by the
requirements of the Medicines Australia (MA) Code of Conduct.
Relevant risk management strategies have been in place including
education of health professionals as well as provision of the Australian Product
Information, Consumer Medicine Information and Instructions for Use as part of
the PFP.
This consent is for approximately 2,159 pre-filled pens and
approximately 868 pre-filled syringes (of NUCALA mepolizumab), batch numbers
9C6B and 8N5G respectively.
Therapeutic product type
Prescription medicines