TYGALINE tigecycline 50 mg Powder for injection Glass vial, Neo Health (Australia) Pty Ltd, CON-339
Product name
TYGALINE tigecycline 50 mg Powder for injection Glass vial
Sponsor name
Neo Health (Australia) Pty Ltd
Consent start
Consent no.
CON-339
Standard
The requirements of the United States Pharmacopeia -National Formulary (USP) monograph Tigecycline for Injection.
Non-compliance with standard
The productsdo not conform to the requirements of the USP monograph for
Tigecycline for Injection, in respect to expiry limit for tigecycline epimer.
Conditions imposed
The products comply with the USP monograph for Tigecycline for Injection
except for the tigecycline epimer impurity, for which the expiry limit of NMT
2.5% applies.
During these 12 months, if the United States Pharmacopeia will not widen
the limit for tigecycline epimer, other steps (eg. reduction of shelf life,
manufacturing improvements, etc.) should be taken to ensure that after this 12
month period, the monograph limit of NMT 2.0% is met at expiry.
Therapeutic product type
Prescription medicines