Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:

Schedule

*Product:*	Pomolide
Active Ingredient:	Pomalidomide 1mg
Dosage Form:	Capsule
New Zealand Sponsor:	Juno Pharmaceuticals NZ Limited
Manufacturer:	Natco Pharma Limited, Telangana, India
Note: This consent is given subject to the following conditions: Pomolide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This renewed consent is valid for two years from the date of the publication of this notice.

*Product:*	Pomolide
Active Ingredient:	Pomalidomide 2mg
Dosage Form:	Capsule
New Zealand Sponsor:	Juno Pharmaceuticals NZ Limited
Manufacturer:	Natco Pharma Limited, Telangana, India
Note: This consent is given subject to the following conditions: Pomolide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This renewed consent is valid for two years from the date of the publication of this notice.

*Product:*	Pomolide
Active Ingredient:	Pomalidomide 3mg
Dosage Form:	Capsule
New Zealand Sponsor:	Juno Pharmaceuticals NZ Limited
Manufacturer:	Natco Pharma Limited, Telangana, India
Note: This consent is given subject to the following conditions: Pomolide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This renewed consent is valid for two years from the date of the publication of this notice.

*Product:*	Pomolide
Active Ingredient:	Pomalidomide 4mg
Dosage Form:	Capsule
New Zealand Sponsor:	Juno Pharmaceuticals NZ Limited
Manufacturer:	Natco Pharma Limited, Telangana, India
Note: This consent is given subject to the following conditions: Pomolide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope of practice of internal medicine. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Pomolide.
Note: This renewed consent is valid for two years from the date of the publication of this notice.

*Product:*	Rilutek
Active Ingredient:	Riluzole 50mg
Dosage Form:	Film coated tablet
New Zealand Sponsor:	Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer:	Opella Healthcare International SAS, Compiegne, France
Note: This consent is given subject to the following conditions: Rilutek Tablets can only be prescribed by authorised prescribers where the prescribing decision is taken in collaboration with, or following consultation with, physicians who care for patients with Motor Neuron Disease, neurologists and palliative care physicians. Rilutek Tablets can only be used by patients with vital capacity greater than 60%.
Note: This renewed consent is valid for two years from the date of the publication of this notice.

Dated this 26th day of September 2025.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Renewal of Provisional Consent to the Distribution of Medicines

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