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: Buvidal Monthly
Active Ingredient: Buprenorphine 160mg
Dosage Form: Injection (depot)
New Zealand Sponsor: CARSL Consulting
Manufacturer: Rechon Life Science AB, Limhamn, Sweden
   
Product: Cetirizine Hayfever & Allergy Relief
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Noumed Pharmaceuticals Limited
Manufacturer: Sai Parenterals Pvt Limited, Bhongir, India
   
Product: Eikance 0.01%
Active Ingredient: Atropine sulfate monohydrate 0.1027mg/mL equivalent to atropine sulfate 0.1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Pharma Stulln GmbH, Stulln, Germany
   
Product: Emesan Travel (Pharmacy Only)
Active Ingredient: Diphenhydramine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Advance Pharma GmbH, Berlin, Germany
   
Product: Emesan Travel (Restricted)
Active Ingredient: Diphenhydramine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: CARSL Consulting
Manufacturer: Advance Pharma GmbH, Berlin, Germany
   
Product: IPCA-Hydroxychloroquine
Active Ingredient: Hydroxychloroquine sulfate 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturers: Ipca Laboratories Limited, Silvassa, India
Ipca Laboratories Limited, Pithampur, India
   
Product: Quichlor
Active Ingredient: Hydroxychloroquine sulfate 200mg
Dosage Form: Coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturers: Ipca Laboratories Limited, Silvassa, India
Ipca Laboratories Limited, Pithampur, India
   
Product: Rivaroxaban Dr.Reddy’s
Active Ingredient: Rivaroxaban 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Rivaroxaban Dr.Reddy’s
Active Ingredient: Rivaroxaban 15mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Rivaroxaban Dr.Reddy’s
Active Ingredient: Rivaroxaban 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Bachupally, India
   
Product: Ticagrelor-Teva
Active Ingredient: Ticagrelor 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Watson Pharma Private Limited, Verna, India
   
Product: Ticagrelor-Teva
Active Ingredient: Ticagrelor 90mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Watson Pharma Private Limited, Verna, India


Dated this 15th day of December 2023.

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