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 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: Codral Cold & Flu
Active Ingredients: Codeine phosphate hemihydrate 9.5mg equivalent to codeine 7.03mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Laverton North, Australia
Product: Codral Nightime Cold & Flu
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Product: Sinutab PE Phenylephrine Sinus & Pain Relief (General Sale)
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Product: Sinutab PE Phenylephrine Sinus & Pain Relief (Pharmacy Only)
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Product: Sinutab PE Phenylephrine Sinus, Allergy & Pain Relief
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Product: Sudafed PE Phenylephrine Sinus + Allergy & Pain Relief
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Product: Sudafed PE Phenylephrine Sinus + Pain Relief
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg equivalent to phenylephrine 4.1mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Product: Sudafed PE Phenylephrine Sinus Day + Night Relief (Combination Product)
Day Tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night Tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Pfizer Laboratories (Pty) Limited, Cape Town, South Africa
Janssen-Cilag, Val de Reuil, France
Dated this 22nd day of June 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).