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:
| 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).