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RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial, UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia, CON-1358
Product name
RYSTIGGO rozanolixizumab 140 mg/mL solution for injection for infusion vial
Sponsor name
UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Batches
CRXJ07
Consent start
Consent no.
CON-1358
Duration
The consent is effective from 26 May 2025 until 28 February 2026.
Standard
8(1)(h), 8(1)(i), 9(1)(g), 9(3)(a), 10(3)(a)(i), 10(3)(b) and 11(5)(iii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not comply as follows: • The storage conditions applicable to
the medicine do not include the permitted temperature ranges. • The name and
contact details of the Australian sponsor, UCB Australia, are not included. •
The route of administration is not stated as for infusion. • The name of the
medicine and the active ingredient on the main label do not appear as a cohesive
unit. • The name and quantity of each excipient in the medicine, expressed as
the nominal mass of that excipient in the stated volume of fill of the injection
in the container are not included. • The statement ‘Use in one patient on one
occasion only. Contains no antimicrobial preservative’ or words to that effect
are not included. • The storage conditions are not stated as ‘Store at 2°C to
8°C (Refrigerate. Do not freeze)'.
Conditions imposed
1. The RYSIGGO vials in UK-labelled packaging will be over-stickered with the
AUST R number 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).
2. The supply of RYSTIGGO vials in UK-labelled 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.
3. 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.
4. This consent is for 530 units of RYSTIGGO rozanolixizumab, batch CRXJ07.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines