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 set out in the Schedule hereto:

Schedule

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

Apo-Olopatadine
Olopatadine hydrochloride 1.11mg/mL equivalent to olopatadine 1mg/mL
Eye drops, solution
Apotex NZ Limited
Apotex Inc, Richmond Hill, Canada

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

Apo-Propranolol
Propranolol hydrochloride 10mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Apo-Propranolol
Propranolol hydrochloride 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

BETADINE Sore Throat Lozenges (Lozenge Fresh Menthol & Eucalyptus)
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

BETADINE Sore Throat Lozenges (Lozenge Orange)
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

BETADINE Sore Throat Lozenges (Lozenge Soothing Honey & Lemon)
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

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

Drofate
Propranolol hydrochloride 10mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Drofate
Propranolol hydrochloride 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Ipca-Propranolol
Propranolol hydrochloride 10mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

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

Ipca-Propranolol
Propranolol hydrochloride 40mg
Tablet
Ipca Pharma (NZ) Pty Limited
Ipca Laboratories Limited, Pithampur, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

MEDIX Cold & Flu PE Decongestion Plus Anti-Inflammatory Pain Relief
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Tablet
Nova Pharmaceuticals NZ Limited
Marksans Pharma Limited, Verna, Ina

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

MEDIX Honey & Lemon Double Antibacterial Lozenges
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

MEDIX Menthol & Eucalyptus Double Antibacterial Lozenges
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

Product:
Active Ingredients:

Dosage Form:

New Zealand Sponsor:
Manufacturer:

MEDIX Orange Double Antibacterial Lozenges
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Lozenge
Nova Pharmaceuticals NZ Limited
Makson Health Care (Private) Limited, Mandideep, India

Product:
Active Ingredients:

Dosage Form:
New Zealand Sponsor:
Manufacturer:

MEDIX Sinus PE Decongestion Plus Anti-Inflammatory Pain Relief
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg
Tablet
Nova Pharmaceuticals NZ Limited
Marksans Pharma Limited, Verna, India

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

Paracetamol Suppositories
Paracetamol 500mg
Suppository
PSM Healthcare Limited trading as API Consumer Brands
PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

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

Sensodyne Deep Clean
Potassium nitrate 5%w/w
Sodium fluoride 0.221%w/w
Toothpaste
GlaxoSmithKline Consumer Healthcare New Zealand Limited
Neocosmed Co Limited, Pathumthani, Thailand

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

Tranexamic Acid Injection
Tranexamic acid 100mg/mL
Solution for injection
Medicianz Healthcare Limited
Bioindustria Laboratorio Italiano Medicinali SpA, Novi Ligure, Italy

Dated this 1st day of September 2017.

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