About Medsafe

Revised: 18 February 2018

What's New

Additions to the Medsafe Website from 5-9 February 2018


SAFETY INFORMATION
Early Warning System Alert Communciations
UPDATE - Heater-cooler devices used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations

CONSUMER MEDICINE INFORMATION
Updated    
Tradename Active ingredient(s) Dose form
Asacol mesalazine tablet
Eliquis apixaban tablet
Gadovist 1.0 gadobutrol injection
Humira adalimumab injection
Isopto Carpine pilocarpine hydrochloride eye drops
Keytruda pembrolizumab infusion
Klacid clarithromycin injection tablet
Neulastim pegfilgrastim injection
Neupogen filgrastim injection
Rheumon etofenamate topical gel
Simbrinza brinzolamide; brimonidine tartrate eye drops
Travatan travoprost eye drops
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Alkeran melphalan tablet
Alkeran melphalan injection
Asacol mesalazine tablet
Diflucan One fluconazole capsule
Eliquis apixaban tablet
Epclusa sofosbuvir; velpatasvir tablet
Gadovist 1.0 gadobutrol injection
Harvoni ledipasvir; sofosbuvir tablet
Humira adalimumab injection
Imatinib-AFT imatinib capsule
Keytruda pembrolizumab infusion
Klacid clarithromycin injection tablet
Lamictal lamotrigine chewable/dispersible tablet
Loette ethinylestradiol; levonorgestrel tablet
Neulastim pegfilgrastim injection
Neupogen filgrastim injection
Noriday norethisterone tablet
Proctosedyl cinchocaine; hydrocortisone rectal ointment suppository
RA-Morph morphine oral solution
Rheumon etofenamate topical gel
Sovaldi sofosbuvir tablet
Vidaza azacitidine injection

Additions to the Medsafe Website from 29 January - 2 February 2018


Committees
Medicines Classification Committee
Recent New Zealand Gazette Notices Relating to Classification
 
Dietary Supplements
Regulation of Dietary Supplements
This page has been reviewed and the links updated.
 
Information for Industry
Current Guidelines on the Regulation of Therapeutic Products in New Zealand
The following guidelines have been updated, which happens as Medsafe regularly reviews its documents. Please ensure you use the latest version of a form when submitting any application to Medsafe.


Medicines
Forms and templates
The following forms have been updated, which happens as Medsafe regularly reviews its documents. Please ensure you use the latest version of a form when submitting any application to Medsafe.

Safety
Early Warning System Monitoring Communications

Media Release
Surgical Mesh Implants - Regulatory action on surgical mesh products

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Pergoveris follitropin; luteinising hormone, human injection
Updated
Tradename Active ingredient(s) Dose form
Azarga brinzolamide; timolol eye drops
Clindamycin ABM clindamycin capsule
Clozaril clozapine tablet
DuoTrav travoprost; timolol eye drops
Elaprase idursulfase infusion
Imigran sumatriptan injection
Nimenrix neisseria meningitidis vaccine; tetanus vaccine injection
Relenza Rodisk zanamivir powder for inhalation
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Bisoprolol (Max Health) bisoprolol tablet
Metformin (Apotex) metformin tablet
Pergoveris follitropin; luteinising hormone, human injection
Piptaz Sandoz piperacillin; tazobactam injection
Updated
Tradename Active ingredient(s) Dose form
Actrapid neutral insulin injection
Apo-Azithromycin azithromycin tablet
Apo-Prazosin prazosin tablet
Clindamycin ABM clindamycin capsule
Clozaril clozapine tablet
DuoTrav travoprost; timolol eye drops
Elaprase idursulfase infusion
Eprex erythropoietin injection
Erbitux cetuximab infusion
FML fluorometholone eye drops
Imigran sumatriptan injection
Mixtard 30 neutral insulin injection
Opdivo nivolumab infusion
Penmix 30 neutral insulin injection
Pred Forte prednisolone ophthalmic suspension
Pred Mild prednisolone ophthalmic suspension
Protaphane neutral insulin injection
Relenza Rodisk zanamivir powder for inhalation
Tranexamic Acid (Boucher & Muir) tranexamic acid tablet
Xeomin botulinum toxin type a injection
Xylocaine Jelly lidocaine topical gel

Additions to the Medsafe Website from 20-26 January 2018

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Alphamox amoxicillin suspension
Updated
Tradename Active ingredient(s) Dose form
Azarga brinzolamide; timolol eye drops
NovoMix 30 FlexPen neutral insulin injection
NovoRapid FlexPen neutral insulin injection
NovoRapid Penfill neutral insulin injection
NuvaRing etonogestrel; ethinylestradiol vaginal ring
Simbrinza brinzolamide; brimonidine tartrate eye drops
Vexazone pioglitazone tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Bricanyl Turbuhaler terbutaline inhaler
Brilinta ticagrelor tablet
CeeNU lomustine capsule
Depo-Testosterone testosterone cipionate injection
Erivedge vismodegib capsule
Etopophos etoposide injection
Glycopyrronium Bromide glycopyrronium bromide injection
Glycopyrronium Bromide and Neostigmine Metilsulfate glycopyrronium bromide; neostigmine injection
Meropenem Ranbaxy meropenem injection
Nimenrix neisseria meningitidis vaccine; tetanus vaccine injection
NuvaRing etonogestrel; ethinylestradiol vaginal ring
Simbrinza brinzolamide; brimonidine tartrate eye drops
Solu-Cortef hydrocortisone injection
Vexazone pioglitazone tablet


Additions to the Medsafe Website from 8-19 January 2018


Committees
Medicines Classification Committee
Minutes of the 59th meeting of the Medicines Classification Committee
Dates and Deadlines

Publications
Recent Official Information Act Releases
Request for adverse reactions with Gardasil 9 (Adobe PDF 4774 KB, 8 pages)
Request for adverse reactions with Gardasil 9(2) (Adobe PDF 8159 KB, 10 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Aldurazyme laronidase infusion
Alecensa alectinib capsule
Calcium Folinate Sandoz folinic acid injection
Cortiment budesonide tablet
Hydrocortisone (Douglas) hydrocortisone tablet
Influvac Tetra influenza vaccine polyvalent injection
Ocrevus ocrelizumab infusion
Opdivo nivolumab infusion
Updated
Tradename Active ingredient(s) Dose form
Belkyra deoxycholic acid injection
Enbrel etanercept injection
Entocort budesonide capsule
Harvoni ledipasvir; sofosbuvir tablet
Ibrance palbociclib capsule
Influvac influenza vaccine polyvalent injection
Intron A Redipen interferon alfa injection
Kivexa abacavir; lamivudine tablet
Pentasa mesalazine enema
Pentasa mesalazine granules
Pentasa mesalazine suppositories
Pentasa mesalazine tablet
Priorix measles vaccine; mumps vaccine; rubella vaccine injection
Seretide fluticasone; salmeterol inhaler
Sovaldi sofosbuvir tablet
Syntometrine ergometrine; oxytocin injection
Triumeq abacavir; dolutegravir; lamivudine tablet
Venclexta venetoclax tablet
Xarelto rivaroxaban tablet
Zyvox linezolid tablet
infusion
oral suspension
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Abilify Maintena aripiprazole injection
Aldurazyme laronidase infusion
Alecensa alectinib capsule
Apo-Gabapentin gabapentin capsule & tablet
Calcium Folinate Sandoz folinic acid injection
Clonidine Hydrochloride clonidine injection
Cortiment budesonide tablet
Influvac Tetra influenza vaccine polyvalent injection
Ocrevus ocrelizumab infusion
Opdivo nivolumab infusion
Updated
Tradename Active ingredient(s) Dose form
Alphamox amoxicillin oral suspension
Atacand candesartan tablet
Betaloc CR metoprolol tablet
Binarex bicalutamide tablet
Cefepime-AFT cefepime injection
Clobex clobetasol shampoo
Copaxone glatiramer injection
DBL Cisplatin cisplatin injection
DBL Flucloxacillin flucloxacillin injection
DBL Gemcitabine gemcitabine injection
DBL Vancomycin hydrochloride vancomycin hydrochloride injection
Hydrocortisone (Douglas) hydrocortisone tablet
Influvac influenza vaccine polyvalent injection
Intron A Redipen interferon alfa injection
Isuprel isoprenaline injection
Kivexa abacavir; lamivudine tablet
Neurontin gabapentin capsule
tablet
Nimenrix neisseria meningitidis vaccine; tetanus vaccine injection
Pentasa mesalazine enema
granules
suppositories
Potassium Chloride and Sodium Chloride (Baxter) potassium chloride; sodium chloride infusion
Prevenar 13 pneumococcal vaccine injection
Sovaldi sofosbuvir tablet
Temgesic buprenorphine injection
Triumeq abacavir; dolutegravir; lamivudine tablet
Venclexta venetoclax tablet
Xarelto rivaroxaban tablet
Xgeva denosumab injection
Xifaxan rifaximin tablet