Gazette.govt.nzPursuant 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: | 0.9% Sodium Chloride (Viaflo) |
| Active Ingredient: | Sodium chloride 0.9%w/v |
| Dosage Form: | Solution for infusion |
| New Zealand Sponsor: | Baxter Healthcare Limited |
| Manufacturer: | Bieffe Medital SA, Huesca, Spain |
| Product: | Bridion |
| Active Ingredient: | Sugammadex 100mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturers: | NV Organon, Oss, Netherlands Patheon Manufacturing Services LLC, North Carolina, United States of America |
| Product: | Dimetapp Cough & Cold |
| Active Ingredients: | Brompheniramine maleate 0.4mg/mL Dextromethorphan hydrobromide monohydrate 2mg/mL Phenylephrine hydrochloride 1mg/mL |
| Dosage Form: | Elixir |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Interphil Laboratories Inc, Cabuyao, Philippines |
| Product: | Dimetapp Cough & Cold Colour Free |
| Active Ingredients: | Brompheniramine maleate 0.4mg/mL Dextromethorphan hydrobromide monohydrate 2mg/mL Phenylephrine hydrochloride 1mg/mL |
| Dosage Form: | Elixir |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Interphil Laboratories Inc, Cabuyao, Philippines |
| Product: | Dimetapp Cough Cold & Flu Daytime/Nightime |
| Component one: | |
| Active Ingredients: | Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg |
| Dosage Form: | Capsule |
| Component two: | |
| Active Ingredients: | Dextromethorphan hydrobromide monohydrate 10mg Doxylamine succinate 6.25mg Paracetamol 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Catalent Australia Pty Limited, Melbourne, Australia |
| Product: | Dimetapp Cough Cold & Flu Decongestant Day & Night |
| Component one: | |
| Active Ingredients: | Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Liquid filled capsule |
| Component two: | |
| Active Ingredients: | Chlorphenamine maleate 2mg Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Catalent Australia Pty Limited, Melbourne, Australia |
| Product: | Dimetapp Cough Cold & Flu Night Relief |
| Active Ingredients: | Chlorphenamine maleate 2mg Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Catalent Australia Pty Limited, Melbourne, Australia |
| Product: | Dimetapp Multi Symptom Cough Cold & Flu |
| Active Ingredient: | Dextromethorphan hydrobromide monohydrate 10mg Paracetamol 300mg Phenylephrine hydrochloride 5mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Catalent Australia Pty Limited, Melbourne, Australia |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 250IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 500IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 750IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 1000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 1500IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 2000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: | Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany Patheon Italia SpA, Ferentino, Italy |
| Product: | ELOCTATE |
| Active Ingredient: | Efmoroctocog alfa 3000IU |
| Dosage Form: | Powder for infusion with diluent |
| New Zealand Sponsor: | sanofi-aventis new zealand limited |
| Manufacturers: |
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 1mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturer: | Mundipharma Pharmaceuticals Limited, Nicosia, Cyprus |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturer: | Bard Pharmaceuticals Limited, Cambridge, United Kingdom |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 10mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturer: | Bard Pharmaceuticals Limited, Cambridge, United Kingdom |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 20mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturer: | Bard Pharmaceuticals Limited, Cambridge, United Kingdom |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 10mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturer: | Hamol Limited, Nottingham, United Kingdom Rafa Laboratories Limited, Jerusalem, Israel |
| Product: | OxyNorm |
| Active Ingredient: | Oxycodone hydrochloride 50mg/mL equivalent to oxycodone base 45mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Mundipharma New Zealand Limited |
| Manufacturers: | Hamol Limited, Nottingham, United Kingdom Rafa Laboratories Limited, Jerusalem, Israel |
| Product: | Repatha |
| Active Ingredient: | Evolocumab 140mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturer: | Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Product: | Repatha (SureClick) |
| Active Ingredient: | Evolocumab 140mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Amgen New Zealand Limited |
| Manufacturer: | Amgen Manufacturing Limited, Juncos, Puerto Rico |
| Product: | Robitussin Cough & Chest Congestion |
| Active Ingredients: | Dextromethorphan hydrobromide monohydrate 3mg/mL Guaifenesin 20mg/mL |
| Dosage Form: | Oral solution |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Interphil Laboratories Inc, Cabuyao, Philippines |
| Product: | Robitussin Dry Cough Forte |
| Active Ingredient: | Dextromethorphan hydrobromide monohydrate 3mg/mL |
| Dosage Form: | Syrup |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Interphil Laboratories Inc, Cabuyao, Philippines |
| Product: | Robitussin Dry Cough Liquid Capsules |
| Active Ingredient: | Dextromethorphan hydrobromide monohydrate 15mg |
| Dosage Form: | Liquid filled capsule |
| New Zealand Sponsor: | GlaxoSmithKline Consumer Healthcare New Zealand ULC |
| Manufacturer: | Catalent Pharma Solutions LLC, Florida, United States of America |
Dated this 19th day of May 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).