✨ Medicine Consent Notices




NEW ZEALAND GAZETTE, No. 46 β€” 26 MAY 2016

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:
Boostrix-IPV

Active Ingredients:
Diphtheria toxoid, adsorbed 2.5Lf U
Pertactin 2.5mcg
Pertussis filamentous haemagglutinin 8mcg
Pertussis toxoid, adsorbed 8mcg
Polio virus type 1 40DAgU
Polio virus type 2 8DAgU
Polio virus type 3 32DAgU
Tetanus toxoid 5Lf U

Dosage Form:
Suspension for injection

New Zealand Sponsor:
GlaxoSmithKline (NZ) Limited

Manufacturers:
GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Saint-Amand-Les-Eaux), Saint-Amand-Les-Eaux, France

Product:
Harvoni

Active Ingredients:
Ledipasvir 90mg
Sofosbuvir 400mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Gilead Sciences (NZ)

Manufacturers:
Patheon Inc, Mississauga, Canada
Gilead Sciences Ireland UC, Carrigtohill, Ireland

Dated this 19th day of May 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

2016-go2933

Provisional Consent to the Distribution of New Medicines

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Pinorax

Active Ingredients:
Dantron 5mg/mL
Poloxamer 188 40mg/mL

Dosage Form:
Oral suspension

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pinewood Laboratories Limited, Clonmel, Ireland

Note: This consent is given subject to the following condition: Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.

Also note: This renewed consent is valid for two years from the date of publication of this notice.

Product:
Pinorax

Active Ingredients:
Dantron 15mg/mL
Poloxamer 188 200mg/mL

Dosage Form:
Oral suspension

New Zealand Sponsor:
AFT Pharmaceuticals Limited

Manufacturer:
Pinewood Laboratories Limited, Clonmel, Ireland

Note: This consent is given subject to the following condition: Pinorax may only be used for the prevention or treatment of constipation in the terminally ill.

Also note: This renewed consent is valid for two years from the date of publication of this notice.

Dated this 19th day of May 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 46





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
19 May 2016
Medicines, Distribution, Boostrix-IPV, Harvoni, Vaccine, Hepatitis C
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Provisional Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
19 May 2016
Medicines, Provisional Consent, Pinorax, Constipation, Terminally Ill
  • CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health