Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:

Trade Name: NexGard SPECTRA

Registration Number: A011184

Active Ingredients and Concentrations:

Each 0.5g chewable contains 9mg afoxolaner and 2mg milbemycin oxime for dogs 2–3.5kg
Each 1g chewable contains 19mg afoxolaner and 4mg milbemycin oxime for dogs 3.6–7.5kg
Each 2g chewable contains 38mg afoxolaner and 8mg milbemycin oxime for dogs 7.6–15kg
Each 4g chewable contains 75mg afoxolaner and 15mg milbemycin oxime for dogs 15.1–30kg
Each 8g chewable contains 150mg afoxolaner and 30mg milbemycin oxime for dogs 30.1–60kg

Formulation Type: Tablet (chewable)

Existing Use Claim:

NexGard SPECTRA kills adult fleas and is indicated for the treatment and prevention of flea (Ctenocephalides spp.) infestations and for the control of NZ cattle tick (Haemaphysalis longicornis) for at least one month. Effective flea control with NexGard SPECTRA also prevents flea tapeworm (Dipylidium caninum) infestation.

Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum), and whipworms (Trichuris vulpis).
Efficacy against the hookworm Uncinaria stenocephala has not been established.

It also treats and controls demodectic mange caused by Demodex spp., sarcoptic mange caused by Sarcoptes scabiei and ear mite (Otodectes cynotis) infestations.

NexGard SPECTRA is safe for all breeds and in puppies 8 weeks and older and weighing 2kg or more. The safe use of NexGard SPECTRA in breeding males and females has not been evaluated.

Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian.

Proposed new claims (changes in bold):

NexGard SPECTRA kills adult fleas and is indicated for the treatment and prevention of flea (Ctenocephalides spp.) infestations and for the control of NZ cattle tick (Haemaphysalis longicornis) for 5 weeks (35 days). Following administration, fleas are killed within 6-8 hours. Effective flea control with NexGard SPECTRA also prevents flea tapeworm (Dipylidium caninum) infestation.

Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum), and whipworms (Trichuris vulpis).

Efficacy against the hookworm Uncinaria stenocephala has not been established.

It also treats and controls demodectic mange caused by Demodex spp., sarcoptic mange caused by Sarcoptes scabiei and ear mite (Otodectes cynotis) infestations.

NexGard SPECTRA is safe for all breeds and in puppies 8 weeks and older and weighing 2kg or more. NexGard SPECTRA has also been shown to be safe in dogs with the ABCB1 (formerly known as MDR-1) gene mutation, such as ivermectin-sensitive Collie breeds. NexGard SPECTRA can be used in breeding, pregnant and lactating females. The safe use of NexGard SPECTRA in breeding males has not been evaluated.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 3, 2 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 10th day of October 2023.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).