Advice summary application for registration of a chemical product



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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.



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