β¨ 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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β¨ LLM interpretation of page content
π₯ Consent to Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Approval, Distribution, Pegatron Combination Therapy
- Minister of Health
NZ Gazette 2013, No 15