Notice Type
Departmental
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 set out in the Schedule hereto: Schedule Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) Meglumine gadoterate 377 mg/mL equivalent to 279.3 mg/mL gadoteric acid in 5 mL Injection, ampoule Laboratoires Guerbet, Alnay-sous-Bois, France Dotarem Meglumine gadoterate 377 mg/mL equivalent to 279.3 mg/mL gadoteric acid in 15 mL, 20 mL Injection, prefilled syringe Laboratoires Guerbet, Alnay-sous-Bois, France Dotarem Meglumine gadoterate 377 mg/mL equivalent to 279.3 mg/mL gadoteric acid in 10 mL, 15 mL, 20 mL Injection, bottle Laboratoires Guerbet, Alnay-sous-Bois, France Dotarem Bromhexine hydrochloride 0.8 mg/mL in 100 mL, 200 mL Liquid, oral 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia Dur-Elix Bromhexine hydrochloride 0.8 mg/mL, pseudoephedrine hydrochloride 4 mg/mL in 100 mL, 200 mL Liquid, oral 3M Pharmaceuticals (Australia) Pty Limited, Thornleigh, New South Wales, Australia Dur-Elix Plus Cefepime hydrochloride 601 mg, 1.202 g, 2.404 g equivalent to 500 mg in 15 mL, 1 g in 15 mL, 2 g in 77 mL cefipime Injection, powder for, vial Bristol-Myers Squibb SpA., Sermoneta, Latina, Italy and Bristol-Myers Squibb Barceloneta Inc., Barceloneta, Puerto Rico Maxipime Cefepime hydrochloride 1.202 mg, 2.404 g equivalent to 1 g, 2 g cefipime in 100 mL Injection, powder for, bottle Bristol-Myers Squibb SpA., Sermoneta, Latina, Italy and Bristol-Myers Squibb Barceloneta Inc., Barceloneta, Puerto Rico Maxipime Dextromethorphan hydrobromide 1 mg/mL, mepyramine maleate 1.67 mg/mL, paracetamol 21.67 mg/mL, pseudoephedrine hydrochloride 2 mg/mL in 25 mL, 30 mL, 100 mL, 200 mL Elixir Wyeth Australia Pty Limited, Smithfield, New South Wales, Australia Robitussin Night Relief Yellow fever virus strain 17 D/AB 237 live, stabilised not less than 1000 mouse LD units in 0.5 mL; and sodium chloride 2 mg in 0.5 ml as diluent Vaccine, injection, ampoule and vial; Diluent, single dose syringe Pasteur Merieux Serums et Vaccins SA., Marcy L'Etoile, France and Pasteur Merieux Serums et Vaccins, Val-De-Reuil Cedex, France Stamaril Dated this 31st day of October 1997. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on 20 February 1997.
Publication Date
6 Nov 1997

Notice Number

1997-go7931

Page Number

3715