Notice Type
Departmental
Consent to the Distribution of Changed Medicines Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Naropin. Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 10 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Naropin. Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 2 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Naropin. Active Ingredient(s): Ropivacaine hydrochloride (monohydrate) 7.5 mg/mL. Dosage Form: Solution for injection. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Ogen. Active Ingredient(s): Piperazine oestrone sulphate 0.75 mg. Dosage Form: Tablet. NZ Sponsor: Pharmacia & Upjohn. Manufacturer(s): Abbott Health Products, Pharmaceutical Products Plant, Cruce Davila, Barceloneta, Spain. Product: Ogen. Active Ingredient(s): Piperazine oestrone sulphate 1.5 mg. Dosage Form: Tablet. NZ Sponsor: Pharmacia & Upjohn. Manufacturer(s): Abbott Health Products, Pharmaceutical Products Plant, Cruce Davila, Barceloneta, Spain. Product: Ogen. Active Ingredient(s): Piperazine oestrone sulphate 3 mg. Dosage Form: Tablet. NZ Sponsor: Pharmacia & Upjohn. Manufacturer(s): Abbott Health Products, Pharmaceutical Products Plant, Cruce Davila, Barceloneta, Spain. Product: Pulmicort Aerosol. Active Ingredient(s): Budesonide 200 g/dose . Dosage Form: Aerosol inhaler, metered dose. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): 3M Health Care (UK) Limited, Loughborough, Leicestershire, England. Product: Pulmicort Nebulising Solution. Active Ingredient(s): Budesonide 0.25 mg/mL. Dosage Form: Suspension for inhalation. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Pulmicort Nebulising Solution. Active Ingredient(s): Budesonide 0.5 mg/mL. Dosage Form: Suspension for inhalation. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): Astra Pharmaceutical Production AB, Sodertalje, Sweden. Astra Pharmaceuticals Pty Limited, North Ryde, New South Wales, Australia. Product: Pulmicort Turbuhaler. Active Ingredient(s): Budesonide 100 g/dose. Dosage Form: Powder for inhalation. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): ASP SA (Astra Pharm Prod AB), Dunkerque, France. Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Pulmicort Turbuhaler. Active Ingredient(s): Budesonide 200 g/dose. Dosage Form: Powder for inhalation. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): ASP SA (Astra Pharm Prod AB), Dunkerque, France. Astra Pharmaceutical Production AB, Sodertalje, Sweden. Product: Pulmicort Turbuhaler. Active Ingredient(s): Budesonide 400 g/dose. Dosage Form: Powder for inhalation. NZ Sponsor: AstraZeneca Limited. Manufacturer(s): ASP SA (Astra Pharm Prod AB), Dunkerque, France. Astra Pharmaceutical Production AB, Sodertalje, Sweden. Dated this 30th day of August 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).
Publication Date
2 Sep 1999

Notice Number

1999-go6420

Page Number

2601