✨ Medicines Approval




NEW ZEALAND GAZETTE, No. 15

14 FEBRUARY 2013

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 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: Pegatron Combination Therapy (Combination Product)

PEG-Intron dose:

  • Active Ingredient: Peginterferon alfa-2b 50mcg
  • Dosage Form: Powder for injection with diluent

Rebetol dose:

  • Active Ingredient: Ribavirin 200mg
  • Dosage Form: Capsule

New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore

Product: Pegatron Combination Therapy (Combination Product)

PEG-Intron dose:

  • Active Ingredient: Peginterferon alfa-2b 80mcg
  • Dosage Form: Powder for injection with diluent

Rebetol dose:

  • Active Ingredient: Ribavirin 200mg
  • Dosage Form: Capsule

New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore

Product: Pegatron Combination Therapy (Combination Product)

PEG-Intron dose:

  • Active Ingredient: Peginterferon alfa-2b 100mcg
  • Dosage Form: Powder for injection with diluent

Rebetol dose:

  • Active Ingredient: Ribavirin 200mg
  • Dosage Form: Capsule

New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore

Product: Pegatron Combination Therapy (Combination Product)

PEG-Intron dose:

  • Active Ingredient: Peginterferon alfa-2b 120mcg
  • Dosage Form: Powder for injection with diluent

Rebetol dose:

  • Active Ingredient: Ribavirin 200mg
  • Dosage Form: Capsule

New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore

Product: Pegatron Combination Therapy (Combination Product)

PEG-Intron dose:

  • Active Ingredient: Peginterferon alfa-2b 150mcg
  • Dosage Form: Powder for injection with diluent

Rebetol dose:

  • Active Ingredient: Ribavirin 200mg
  • Dosage Form: Capsule

New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Schering-Plough Products Inc, Las Piedras, Puerto Rico
MSD International GmbH (Singapore Branch), Singapore



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 15





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Approval, Distribution, Pegatron Combination Therapy
  • Minister of Health