KINERET anakinra 100 mg/0.67 mL solution for injection prefilled syringe, A. Menarini Australia Pty Ltd , CON-362
Product name
KINERET anakinra 100 mg/0.67 mL solution for injection prefilled syringe
Sponsor name
A. Menarini Australia Pty Ltd
Consent start
Consent no.
CON-362
Standard
Paragraphs 8(1)(h), 8(1)(i), subparagraphs 9(3)(a)(ii), 11(5)(iii) and 11(5)(vi) in the Therapeutics Goods Order 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels do not include thestorage conditionscontact details of the
Sponsorthe active name and quantity of each active ingredient together
immediately below the name of the medicine
Conditions imposed
1. Supply is restricted to the UK sourced Kineret Product in Australian-specific
28s carton as provided to the Therapeutic Goods Administration (TGA )in the
application.2. The sponsor must inform the TGA in at least once every 12 months
of the numbers of patients treated with the Product in the previous 12 month
period. This information should be submitted to biological.medicines@tga.gov.au
unless you have reached agreement with the TGA for an alternative.3. A
DearHealthCareProfessional letter will be sent to all relevant hospital
pharmacies explaining the altered packaging of Kineret as detailed in company's
application and previous correspondence.4. The consent is granted until the
medicine is listed on the PharmaceuticalBenefitScheme (PBS) for indications
other than the orphan indication cryopyrin-associated periodic syndromes (CAPS).
The sponsor must inform the TGA in writing as soon as possible when new
indication is listed on the PBS.
Therapeutic product type
Prescription medicines