Advice summary application for registration of a chemical product

ADVICE SUMMARY

APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT

Product name: TROCOXIL 95MG CHEWABLE TABLETS FOR DOGS

Applicant: PFIZER ANIMAL HEALTH A DIV OF PFIZER AUSTRALIA PTY LTD

Product number: 64462

Application number: 48415

Purpose of Application and Description of Use: Registration of a 95mg mavacoxib tablet product for the treatment of pain and inflammation associated with degenerative joint disease in dogs, in conjunction with the approval of mavacoxib (**654/64462).

Active Constituent(s):

MAVACOXIB

Regulatory Decision:

To grant the application subject to the following conditions:

Standard Conditions of Registration/Approval

1. 
   Containers must meet AgVet Code Regulation 18 (Condition of Registration - All products)
   
2. 
   Shelf Life - Label must contain an expiry date (Condition of Registration - Vet products and date controlled Ag products)
   
3. 
   Product must not be supplied without meeting GMP Requirements (Condition of Registration - Vet products)
   
4. 
   Label must contain an Expiry Date and Batch Number
   

1. 
   Product Label (MPL) must comply with Labelling Standard / Code
   
2. 
   Statutory linking conditions MPL
   

(Vet only)

For full conditions, refer to Standard Conditions for Applications on the APVMA website.