Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: APO-CANDESARTAN HCTZ 16/12.5
Active Ingredients: Candesartan cilexetil 16mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Alembic Pharmaceuticals Limited, Gujarat, India

 

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

  • The medicine may only be marketed or distributed when no other candesartan cilexetil/hydrochlorothiazide medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, to meet sole tender obligations.

Note: This consent is valid for two years from the date of publication of this notice.

Product: APO-CANDESARTAN HCTZ 32/12.5
Active Ingredients: Candesartan cilexetil 32mg
Hydrochlorothiazide 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Alembic Pharmaceuticals Limited, Gujarat, India

 

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

  • The medicine may only be marketed or distributed when no other candesartan cilexetil/hydrochlorothiazide medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, to meet sole tender obligations.

Note: This consent is valid for two years from the date of publication of this notice.

Product: APO-CANDESARTAN HCTZ 32/25
Active Ingredients: Candesartan cilexetil 32mg
Hydrochlorothiazide 25mg
Dosage Form: Tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Alembic Pharmaceuticals Limited, Gujarat, India

 

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

  • The medicine may only be marketed or distributed when no other candesartan cilexetil/hydrochlorothiazide medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, to meet sole tender obligations.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 2.5mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 5mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 7.5mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 10mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 15mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 20mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Lenalidomide Juno
Active Ingredient: Lenalidomide 25mg
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:

  1. Lenalidomide Juno 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.
  2. Juno Pharmaceuticals NZ Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Juno.

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 5th day of September 2022.

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