Notice Title

Consent to the Distribution of New Medicines

Publication Date
18 Jan 2024

Tags

Medicines Act Consent to the distribution of new medicines Health

Notice Number

2024-go182
Title
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File Type and Size
PDF (45 KB)

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: APO-Paracetamol 665mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India
   
Product: Colchicine Indoco
Active Ingredient: Colchicine 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Miro Healthcare Limited
Manufacturer: Indoco Remedies Limited, Verna, India
   
Product: Fulvestrant-AFT
Active Ingredient: Fulvestrant 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Jiangsu Hansoh Pharmaceutical Co Limited, Lianyungang, China
   
Product: Nortriptimed
Active Ingredient: Nortriptyline hydrochloride 11.38mg equivalent to nortriptyline 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Nortriptimed
Active Ingredient: Nortriptyline hydrochloride 28.46mg equivalent to nortriptyline 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Nortriptyline (Medsurge)
Active Ingredient: Nortriptyline hydrochloride 11.38mg equivalent to nortriptyline 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Nortriptyline (Medicianz)
Active Ingredient: Nortriptyline hydrochloride 11.38mg equivalent to nortriptyline 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Nortriptyline (Medsurge)
Active Ingredient: Nortriptyline hydrochloride 28.46mg equivalent to nortriptyline 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Nortriptyline (Medicianz)
Active Ingredient: Nortriptyline hydrochloride 28.46mg equivalent to nortriptyline 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Medsurge Pharma Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
   
Product: Omeprazole
Active Ingredient: Omeprazole 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
   
Product: Omeprazole
Active Ingredient: Omeprazole 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
   
Product: Omeprazole
Active Ingredient: Omeprazole 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: Teva Pharma (New Zealand) Limited
Manufacturer: Laboratorios Liconsa SA, Guadalajara, Spain
   
Product: Osteo Relief Paracetamol
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India
   
Product: Paliperidone ADVZ (25mg/0.25mL)
Active Ingredient: Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Paliperidone ADVZ (50mg/0.5mL)
Active Ingredient: Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Paliperidone ADVZ (75mg/0.75mL)
Active Ingredient: Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Pharmathen International SA, Rodopi Greece
   
Product: Paliperidone ADVZ (100mg/1mL)
Active Ingredient: Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Paliperidone ADVZ (150mg/1.5mL)
Active Ingredient: Paliperidone palmitate 156mg/mL equivalent to paliperidone 100mg/mL
Dosage Form: Suspension for injection
New Zealand Sponsor: Boucher & Muir (NZ) Limited t/a Mercury Pharma (NZ)
Manufacturer: Pharmathen International SA, Rodopi, Greece
   
Product: Paracetamol 665 mg
Active Ingredient: Paracetamol 665mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Arrotex Pharmaceuticals (NZ) Limited
Manufacturer: Gracure Pharmaceuticals Limited, Bhiwadi, India
   
Product: Rubifen LA
Active Ingredient: Methylphenidate hydrochloride 10mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Valpharma International SpA, Pennabilli, Italy
   
Product: Rubifen LA
Active Ingredient: Methylphenidate hydrochloride 20mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Valpharma International SpA, Pennabilli, Italy
   
Product: Rubifen LA
Active Ingredient: Methylphenidate hydrochloride 30mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Valpharma International SpA, Pennabilli, Italy
   
Product: Rubifen LA
Active Ingredient: Methylphenidate hydrochloride 40mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Valpharma International SpA, Pennabilli, Italy
   
Product: Rubifen LA
Active Ingredient: Methylphenidate hydrochloride 60mg
Dosage Form: Modified release capsule
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Valpharma International SpA, Pennabilli, Italy
   
Product: Thiotepa-Reach
Active Ingredient: Thiotepa 15mg
Dosage Form: Powder for infusion
New Zealand Sponsor: CARSL Consulting
Manufacturer: MSN Laboratories Private Limited, Mandal, India
   
Product: Thiotepa-Reach
Active Ingredient: Thiotepa 100mg
Dosage Form: Powder for infusion
New Zealand Sponsor: CARSL Consulting
Manufacturer: MSN Laboratories Private Limited, Mandal, India
   
Product: Tremfya (pre-filled pen)
Active Ingredient: Guselkumab 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland
   
Product: Tremfya (pre-filled syringe)
Active Ingredient: Guselkumab 100mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Cilag AG, Schaffhausen, Switzerland


Dated this 15th day of January 2024.

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