LEMTRADA alemtuzumab 10 mg/mL injection concentrated vial, Commercial Eyes Pty Ltd (on behalf of Sanofi-Aventis Australia Pty Ltd), CON-670
Product name
LEMTRADA alemtuzumab 10 mg/mL injection concentrated vial
Sponsor name
Commercial Eyes Pty Ltd (on behalf of Sanofi-Aventis Australia Pty Ltd)
Consent start
Consent no.
CON-670
Standard
Therapeutic Goods Order No.91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
Section 6 - The name of the medicine on the main panel is not the most
conspicuously shown. Section 8(1)(o) - The name of medicine is not present on at
least three non-opposing sides. Section 6 '“ One excipient present on the label
is not the Australian Approved Name.
Therapeutic product type
Prescription medicines