✨ Medicines Distribution Consents




NEW ZEALAND GAZETTE, No. 84

12 JULY 2012

Health

Medicines Act 1981

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:

Schedule

Product:
Avonex Pen

Active Ingredient:
Interferon beta-1a 60Β΅g/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics

Manufacturers:
Catalent Pharma Solutions LLC, Pennsylvania, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Biogen Idec Denmark Manufacturing ApS, Hillerod, Denmark

Product:
Lemsip Ibuprofen Cold & Flu Liquid Capsules

Active Ingredients:
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg

Dosage Form:
Soft gelatin capsule

New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited

Manufacturer:
Softgel Healthcare Pvt. Limited, Tamilnadu, India

Product:
Lemsip Multi Relief Cold & Flu Liquid

Active Ingredients:
Guaifenesin 200mg
Paracetamol 1000mg
Phenylephrine hydrochloride 12.2mg

Dosage Form:
Linctus

New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited

Manufacturer:
Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom

Product:
Nurofen Cold & Flu PE Liquid Capsules

Active Ingredients:
Ibuprofen 200mg
Phenylephrine hydrochloride 5mg

Dosage Form:
Soft gelatin capsule

New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited

Manufacturer:
Softgel Healthcare Pvt. Limited, Tamilnadu, India

Product:
Paracetamol-AFT

Active Ingredient:
Paracetamol 10mg/mL

Dosage Form:
Solution for infusion

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturers:
Fresenius Kabi Deutschland GmbH, Friedberg, Germany
S.M. Farmaceutici SRL, Zona Industriale, Italy

Dated this 5th day of July 2012.

DR STEWART JESSAMINE, 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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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product:
Bicillin L-A

Active Ingredient:
Benzathine benzylpenicillin tetrahydrate 450mg/mL

Dosage Form:
Suspension for injection

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturers:
Wyeth Pharmaceuticals Inc, Pennsylvania, United States of America
King Pharmaceuticals Inc, Michigan, United States of America

Note: This renewed consent is valid for two years from 7 August 2012.



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2012, No 84





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
5 July 2012
Medicines Act 1981, New Medicines, Distribution Consent, Avonex Pen, Lemsip Ibuprofen Cold & Flu, Lemsip Multi Relief Cold & Flu, Nurofen Cold & Flu PE, Paracetamol-AFT
  • Dr Stewart Jessamine, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
5 July 2012
Medicines Act 1981, Provisional Consent Renewal, Bicillin L-A, Pfizer New Zealand Limited
  • Dr Stewart Jessamine, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health