tigecycline (TYGACYCLINE) 50 mg Powder for injection Glass vial, Neo Health (Australia) Pty Ltd, CON-157
Product name
tigecycline (TYGACYCLINE) 50 mg Powder for injection Glass vial
Sponsor name
Neo Health (Australia) Pty Ltd
Consent start
Consent no.
CON-157
Standard
The requirements of the United States Pharmacopeia monograph Tigecycline for Injection.
Non-compliance with standard
The goods do not need to comply with the limit applied to the specified impurity
tigecycline epimer.
Conditions imposed
The expiry limit for the tigecycline epimer will be NMT 2.5%.
Therapeutic product type
Prescription medicines