✨ Medicine Distribution Consent




21 FEBRUARY 2013 NEW ZEALAND GAZETTE, No. 21 569

Schedule

Product: Allertyne
Active Ingredient: Loratadine 10mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Drug Houses of Australia Private Limited, Singapore

Product: AS-Paclitaxel
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India

Product: GN-Paclitaxel
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India

Product: Imodium Capsules (Pharmacy Only)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag, Val de Reuil, France

Product: Imodium Capsules (General Sales)
Active Ingredient: Loperamide hydrochloride 2mg
Dosage Form: Capsule
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturers: Janssen Pharmaceutica NV, Beerse, Belgium
Janssen-Cilag, Val de Reuil, France

Product: Paclitox
Active Ingredient: Paclitaxel 6mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Agila (NZ) Pty Limited
Manufacturer: Onco Therapies Limited, Bangalore Karnataka, India

Product: Vinorelbine
Active Ingredient: Vinorelbine tartrate 13.85mg/mL equivalent to Vinorelbine 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Ltd, Goa, India

Dated this 14th day of February 2013.

Dr DON MACKIE, 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).

go975

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Buccaline
Active Ingredients: Haemophilus influenzae type b 1500million organisms
Pneumococcus I,II,III 1000million organisms
Staphylococcus aureus 1000million organisms
Streptococcus agalactiae 1000million organisms
Dosage Form: Tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: Laboratorio Farmaceutico SIT S.r.l, Pavia, Italy



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 21





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
14 February 2013
Medicines Act, New Medicines, Distribution Consent, Allergy, Paclitaxel, Loperamide, Vinorelbine
  • Dr DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
Medicines Act, New Medicine, Distribution Consent, Buccaline, Haemophilus influenzae, Pneumococcus, Staphylococcus aureus, Streptococcus agalactiae