Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 86

23 JUNE 2011

Product: I-Fluconazole
Active Ingredient: Fluconazole 200mg
Dosage Form: Capsule
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Dadra and Nagar Haveli, India

Product: Imodium Advanced
Active Ingredients:

  • Loperamide hydrochloride 2mg
  • Simeticone 125mg
    Dosage Form: Chewable tablet
    New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
    Manufacturer: Johnson & Johnson / Merck Consumer Pharmaceutical Company, Pennsylvania, United States of America

Product: Imodium Caplets
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico

Product: Nuromol (General Sale)
Active Ingredients:

  • Ibuprofen 200mg
  • Paracetamol 500mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
    Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

Product: Nuromol (Pharmacy Only)
Active Ingredients:

  • Ibuprofen 200mg
  • Paracetamol 500mg
    Dosage Form: Film coated tablet
    New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
    Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

Product: Sudafed PE Sinus + Anti-inflammatory Pain Relief (General Sale)
Active Ingredients:

  • Ibuprofen 200mg
  • Phenylephrine hydrochloride 5mg
    Dosage Form: Tablet
    New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
    Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa

Product: Sudafed PE Sinus + Anti-inflammatory Pain Relief (Pharmacy Only)
Active Ingredients:

  • Ibuprofen 200mg
  • Phenylephrine hydrochloride 5mg
    Dosage Form: Tablet
    New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
    Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa

Product: Vagifem Low
Active Ingredients: Estradiol hemihydrate 0.0103mg equivalent to anhydrous estradiol 10mcg
Dosage Form: Pessary
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Måløv, Denmark

Product: Voltaren Spray
Active Ingredient: Diclofenac sodium 4%w/w
Dosage Form: Topical spray
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Pharbil Waltrop GmbH, Waltrop, Germany

Dated this 17th 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).

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Gazette.govt.nz PDF NZ Gazette 2011, No 86





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🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
17 June 2011
Medicines Act, New Medicines, Distribution, Fluconazole, Loperamide, Simeticone, Ibuprofen, Paracetamol, Diclofenac, Estradiol
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health