YONDELIS trabectedin 1 mg powder for solution for infusion vial, Specialised Therapeutics Australia Pty Ltd, CON-1250
Product name
YONDELIS trabectedin 1 mg powder for solution for infusion vial
Sponsor name
Specialised Therapeutics Australia Pty Ltd
Batches
3I001A4, 4A013A1
Consent start
Consent no.
CON-1250
Standard
Paragraph 8(1)(l) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not contain the information required by 8(1)(l) in relation to
the preparation and storage of the prepared medicine on the label or on a
package insert.
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the TGA on 20
June 2024 will be supplied with each affected batch describing where the package
insert information containing the information required under 8(1)(l) can be
found.
Therapeutic product type
Prescription medicines