New Zealand Gazette – 1998 – No. 196

Page 4648

✨ Medicines Consent Notices

4648 NEW ZEALAND GAZETTE No. 196

Schedule

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Factor II 500 IU, factor IX 500 IU, factor X 500 IU with water for injection 20 mL as diluent	Injection, powder with diluent	CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia. Diluent: Pharmacia & Upjohn (Perth) Pty Limited, Bentley, Western Australia, Australia	Prothrombinex-HT

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 26th day of November 1998.

G. R. BOYD,
Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.

g08566

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

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Mesalazine 1% w/v, 4% w/v	Enema	Tillotts Pharma AG., Ziefen, Switzerland	Asacol Enema
Metoprolol succinate 47.5 mg, 95 mg, 190 mg	Tablets, modified release	Astra Pharmaceutical Production AB., Södertälje, Sweden	Betaloc CR
Bromhexine hydrochloride 1.6 mg/mL	Solution, oral	Boehringer Ingelheim Pharma KG., Biberach an der Riss, Germany and Boehringer Ingelheim France, Reims Cedex, France	Bisolvon Elixir
Alendronate sodium 13.05 mg, 52.21 mg equivalent to 10 mg, 40 mg alendronic acid	Tablets	Merck Manufacturing Division, Bo. Sabana Hoyos, Arecibo, Puerto Rico and Merck Sharp & Dohme Italia SpA., Pavia, Italy	Fosamax
Ispaghula husk 5.25 mg/dose	Granules, oral	Reckitt & Colman Products Limited, Hull, North Humberside, United Kingdom	Fybogest Forte Orange, Fybogest Forte Regular
Ispaghula husk 5.25 mg/dose	Granules, oral	Reckitt & Colman Products Limited, Hull, North Humberside, United Kingdom	Fybogest Orange, Fybogest Regular
Ispaghula husk 3.5 mg/dose	Granules, oral	Reckitt & Colman Products Limited, Hull, North Humberside, United Kingdom	Fybogest Regular
Somatropin 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, 2 mg	Injection with diluent	Vetter Pharma-Fertigung GmbH & Co Kg., Ravensburg, Germany and Recip AB., Stockholm, Sweden	Genotropin Miniquick
Midazolam hydrochloride 1 mg/mL, 5 mg/mL	Injection, solution	F Hoffmann-La Roche Limited, Basle, Switzerland	Hypnovel
Caldiamide sodium 12 mg/mL, gadodiamide 287 mg/mL	Injection, solution	Nycomed AS Production, Oslo, Norway; Nycomed Puerto Rico Inc., Barceloneta, Puerto Rico and Nycomed Ireland Limited, Carrigtwohill, County Cork, Eire	Omniscan
Pantoprazole sodium sesquihydrate 22.6 mg, 45.1 mg equivalent to 20 mg, 40 mg pantoprazole	Tablets, enteric coated	Byk Gulden Lomberg Chemische Fabrik GmbH., Konstanz, Germany and Oranienburger Pharmawerk GmbH., Oranienburg, Germany	Somac
Ondansetron 4 mg, 8 mg	Wafer	Scherer DDS Limited, Blagrove, Swindon, Wiltshire, England	Zofran Zydis
Goserelin acetate 3.6 mg	Implant, subcutaneous	Zeneca Pharmaceuticals, Macclesfield, Cheshire, England	Zoladex Injectable Implant

Dated this 26th day of November 1998.

G. R. BOYD,
Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.

g08567

Consent to the Distribution of Changed Medicines

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VUW Te Waharoa — NZ Gazette 1998, No 196

NZLII — NZ Gazette 1998, No 196

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Provisional Consent to the Distribution of a New Medicine (continued from previous page)

Domain🏥 Health & Social Welfare
Dated26 November 1998
KeywordsMedicines Act 1981, Provisional Consent, Factor II, Factor IX, Factor X
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Regulation and Safety

🏥 Consent to the Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
Dated26 November 1998
KeywordsMedicines Act 1981, Consent, Mesalazine, Metoprolol succinate, Bromhexine hydrochloride, Alendronate sodium, Ispaghula husk, Somatropin, Midazolam hydrochloride, Caldiamide sodium, Pantoprazole sodium sesquihydrate, Ondansetron, Goserelin acetate
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Regulation and Safety

🏥 Consent to the Distribution of Changed Medicines

Domain🏥 Health & Social Welfare
Dated26 November 1998
KeywordsMedicines Act 1981, Consent, Changed Medicines
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Regulation and Safety

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