✨ Consent to Distribution of New Medicines




21 JULY 2011 NEW ZEALAND GAZETTE, No. 109 3129

Product: Easitrav
Active Ingredient: Cyclizine hydrochloride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Etoposide
Active Ingredient: Etoposide 20mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India

Product: Glypressin
Active Ingredient: Terlipressin 0.85mg equivalent to terlipressin diacetate 1mg
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Zentiva AS (Czech Republic), Prague, Czech Republic

Product: Silagra
Active Ingredient: Sildenafil citrate 35.12mg equivalent to sildenafil 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Silagra
Active Ingredient: Sildenafil citrate 70.24mg equivalent to sildenafil 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Silagra
Active Ingredient: Sildenafil citrate 140.48mg equivalent to sildenafil 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India

Product: Your Pharmacy Congested Cold & Cough Medicine
Active Ingredients:
Brompheniramine maleate 0.4mg/mL
Dextromethorphan hydrobromide monohydrate 2mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand

Dated this 13th day of July 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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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 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: Enbrel
Active Ingredient: Etanercept 25mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: DSM Pharmaceuticals Inc, North Carolina, United States of America
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product: Enbrel
Active Ingredient: Etanercept 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: DSM Pharmaceuticals Inc, North Carolina, United States of America
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2011, No 109





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
13 July 2011
Medicines, Distribution, Consent, Medicines Act 1981
  • MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health