SIGNIFOR LAR pasireotide 60 mg (as embonate) modified release powder for injection vial and 2 mL diluent in prefilled syringe composite pack, Accelagen (agent on behalf of the sponsor, Recordati Rare Diseases Australia), CON-419
Product name
SIGNIFOR LAR pasireotide 60 mg (as embonate) modified release powder for injection vial and 2 mL diluent in prefilled syringe composite pack
Sponsor name
Accelagen (agent on behalf of the sponsor, Recordati Rare Diseases Australia)
Consent start
Consent no.
CON-419
Standard
Paragraph 8(1)(i) and 10(5)(g) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The productslabels state the sponsor is Novartis, which does not reflect the
current sponsorship of the product as Recordati Rare Diseases Australia Pty
Ltdpre-filled syringe diluent label of SIGNIFOR LAR does not include the
approved route of administration of the medicine
Therapeutic product type
Prescription medicines