CECLOR cefaclor 250 mg/5 mL (as monohydrate) powder for oral liquid bottle, Mylan Health Pty Ltd, CON-676
Product name
CECLOR cefaclor 250 mg/5 mL (as monohydrate) powder for oral liquid bottle
Sponsor name
Mylan Health Pty Ltd
ARTG
54898
Batches
0001E0
Consent start
Consent no.
CON-676
Standard
The Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform with the requirements of TGO 91 due to global
supply chain issues in introducing the TGO 91 compliant labels into the
manufacturing process. However, the product is supplied with labels that have
been approved by the TGA, assessed against TGO 69 requirements.
Therapeutic product type
Prescription medicines