How do you find using the New Zealand Gazette? Please give your feedback by completing this survey.

Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

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 medicine set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Doxylin 100
Doxycycline hydrochloride 115mg equivalent to doxycycline 100mg
Film coated tablet
Mylan New Zealand Limited
Alphapharm Pty Limited, Brisbane, Australia

Note: Provisional consent is subject to the following restrictions:

  • Provisional consent is to be granted for three months to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other doxycycline immediate release oral dosage forms with consent to distribute are available on the New Zealand market and to meet sole supply obligations.

Note: This consent is valid for three months from the date of publication of this notice.

Dated this 7th day of May 2018.

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