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: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 2.5mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 5mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 7.5mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 10mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 15mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 20mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lenalidomide Te Arai
Active Ingredient: Lenalidomide 25mg
Dosage Form: Capsule
New Zealand Sponsor: Te Arai BioFarma Limited
Manufacturer: Lotus Pharmaceutical Co, Limited, Nantou City, Taiwan
Note: This consent is given subject to the following conditions:
  1. Lenalidomide Te Arai 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. Te Arai BioFarma Limited will manage a pregnancy prevention programme relating to the distribution and use of Lenalidomide Te Arai.
Also note: This consent is valid for two years from the date of publication of this notice.

Dated this 21st day of October 2019.

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