Note: This consent is given subject to the following condition:

The New Zealand Sponsor must provide confirmatory data from the ongoing phase 3 randomised, open label, study BGB-3111-306 comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated mantle cell lymphoma who are ineligible for stem cell transplantation.

Note: This renewed consent is valid for two years from 8 June 2025.

Note: This consent is given subject to the following condition:

The New Zealand Sponsor must provide confirmatory efficacy and safety data from ongoing and future clinical trials, in particular study 1540, as soon as they become available.

Note: This renewed consent is valid for two years from 29 June 2025.

Note: This consent is given subject to the following condition:

The medicine may only be marketed or distributed when no other oxybutynin hydrochloride tablet medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.

Note: This renewed consent is valid for two years from 6 July 2025.

Note: This consent is given subject to the following conditions:

The New Zealand Sponsor must fulfil the following obligations:

1. Provide confirmatory safety and efficacy data from the ongoing study 61186372NSC3001.
2. Provide an update regarding the re-evaluation (and possible revision) of the drug substance specifications following the manufacture of 30 commercial-scale drug substance batches and update the specification ranges/limits as appropriate.
3. Provide an update regarding the re-evaluation (and possible revision) of the drug product specification ranges/limits following the manufacture of 30 commercial-scale drug product batches and update the specification ranges/limits as appropriate.

Note: This renewed consent is valid for two years from 8 June 2025.