Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Acupan
Nefopam hydrochloride 30mg
Tablet
iNova Pharmaceuticals (New Zealand) Limited
3M Health Care (UK) Limited, Loughborough, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Dalacin C Phosphate
Clindamycin phosphate 178.22mg/mL equivalent to clindamycin 150mg/mL
Solution for injection
Pfizer New Zealand Limited
Pfizer Manufacturing Belgium NV, Puurs, Belgium

Product:
Active Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturers:

Genvoya
Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir alafenamide 10mg
Tablet
Gilead Sciences (NZ)
Patheon Inc, Ontario, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 2.5mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 5mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 7.5mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 10mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 15mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 20mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Revlimid
Lenalidomide 25mg
Capsule
Celgene Limited
Penn Pharmaceutical Services Limited, Tredegar, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Product:
Active Ingredients:



Dosage Form:
New Zealand Sponsor:
Manufacturers:

Stribild
Cobicistat 150mg
Elvitegravir 150mg
Emtricitabine 200mg
Tenofovir disoproxil fumarate 300mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Ontario, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Tybost
Cobicistat 150mg
Film coated tablet
Gilead Sciences (NZ)
Patheon Inc, Ontario, Canada


Dated this 18th day of December 2018.

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