Medicine Approvals




NEW ZEALAND GAZETTE, No. 15
14 FEBRUARY 2013

Rebetol dose:

Active Ingredient: Ribavirin 200mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers:

  • Schering-Plough Company, County Cork, Ireland
  • Schering-Plough Products Inc, Las Piedras, Puerto Rico
  • Schering-Plough (Singapore) Pte Limited, Singapore
  • MSD International GmbH (Singapore Branch), Singapore

Product:

Victrelis® Pegatron® Combination Therapy (Combination Product)

Victrelis dose:

Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule

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 Company, County Cork, Ireland
  • Schering-Plough Products Inc, Las Piedras, Puerto Rico
  • Schering-Plough (Singapore) Pte Limited, Singapore
  • MSD International GmbH (Singapore Branch), Singapore

Product:

Victrelis® Pegatron® Combination Therapy (Combination Product)

Victrelis dose:

Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule

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 Company, County Cork, Ireland
  • Schering-Plough Products Inc, Las Piedras, Puerto Rico
  • Schering-Plough (Singapore) Pte Limited, Singapore
  • MSD International GmbH (Singapore Branch), Singapore

Product:

Victrelis® Pegatron® Combination Therapy (Combination Product)

Victrelis dose:

Active Ingredient: Boceprevir 200mg
Dosage Form: Capsule

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 Company, County Cork, Ireland
  • Schering-Plough Products Inc, Las Piedras, Puerto Rico
  • Schering-Plough (Singapore) Pte Limited, Singapore
  • MSD International GmbH (Singapore Branch), Singapore

Product:

Zoledronate-DRLA
Active Ingredient: Zoledronic acid monohydrate 0.0533mg/mL equivalent to zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Gland Pharma Limited, Andhara Pradesh, India



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Online Sources for this page:

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





✨ LLM interpretation of page content

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

🏥 Health & Social Welfare
Medicines, Approval, Distribution, Rebetol, Victrelis, Pegatron, Zoledronate-DRLA