We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
NPLATE romiplostim (rbe) 625 microgram powder for injection vial, Amgen Australia Pty Ltd, CON-1009
Product name
NPLATE romiplostim (rbe) 625 microgram powder for injection vial
Sponsor name
Amgen Australia Pty Ltd
Consent start
Consent no.
CON-1009
Duration
The consent is effective from 13 September 2022 until 01 September 2023.
Standard
Paragraph 8(1)(i) of the Therapeutic Goods Order No.91 – Standard for labels of prescription and related medicines (TGO 91).
Non-compliance with standard
The product labels do not comply with the paragraph 8(1)(i) of TGO 91 in that,
on the cartons the contact details of the distributor of the medicine are not
current.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines