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About Medsafe

Revised: 27 March 2017

What's New


Additions to the Medsafe Website from 3-28 April 2017


ABOUT MEDSAFE
Vacancies
Advisor/Senior Advisor Science
 
COMMITTEES
Medicines Assessment Advisory Committee
Summary of recommendations from the 104th meeting - 23 February 2017
 
Medicines Adverse Reactions Committee
Minutes for the 169th meeting - 9 March 2017
 
Medicines Classification Committee
Comments on agenda for the 58th meeting
 
MEDICINES
Policy Statements
Tips for changing to the new data sheet format
 
PUBLICATIONS
Recent Official Information Act Releases
Request for data on erectile dysfunction drugs being stopped at the NZ boarder (Adobe PDF 2027KB, 5 pages) 


CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Tecentriq atezolizumab infusion
Trinomia aspirin; atorvastatin; ramipril capsule
Vitalipid N (adult & infant) dl-alpha tocopherol; ergocalciferol; phytomenadione; retinol injection
Updated
Tradename Active ingredient(s) Dose form
Bezalip bezafibrate tablet
Brevinor ethinyloestradiol; norethisterone tablet
Brevinor 21 day ethinyloestradiol; norethisterone tablet
Brevinor 28 day ethinyloestradiol; norethisterone tablet
Cefuroxime cefuroxime injection
Concerta methylphenidate tablet
Diane-35 ED cyproterone; ethinylestradiol tablet
Dipentum olsalazine capsule
tablet
Fluvax influenza vaccine polyvalent injection
Fortum ceftazidime injection
Glycophos sodium glycerophosphate infusion
Imbruvica ibrutinib capsule
Inlyta axitinib tablet
Isoptin verapamil tablet
Isoptin verapamil injection
Keytruda pembrolizumab infusion
Lemtrada alemtuzumab infusion
Levothyroxine levothyroxine tablet
Loette ethinyloestradiol; levonorgestrel tablet
Monofeme ethinyloestradiol; levonorgestrel tablet
Normin ethinyloestradiol; norethisterone tablet
NuvaRing ethinylestradiol; etonogestrel vaginal ring
Opdivo nivolumab infusion
Plaquenil hydroxychloroquine sulfate tablet
Rotarix rotavirus vaccine
Stocrin efavirenz tablet
Varilrix varicella vaccine injection
Yasmin drospirenone; ethinylestradiol tablet
Yaz drospirenone; ethinylestradiol tablet
Zapril cilazapril tablet
Zarator atorvastatin calcium tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apomorphine apomorphine infusion
Bimatoprost Actavis bimatoprost eye drops solution
Dilantin phenytoin sodium capsule
tablet
oral suspension
Tecentriq atezolizumab infusion
Trinomia aspirin; atorvastatin; ramipril capsule
Vitalipid N (adult & infant) dl-alpha tocopherol; ergocalciferol; phytomenadione; retinol injection
Updated
Tradename Active ingredient(s) Dose form
Antabuse disulfiram tablet
Arrow-Fluoxetine fluoxetine capsule
tablet
Arrow-Iloprost Iloprost infusion
Arrow-Lamotrigine lamotrigine tablet
Arrow-Lisinopril lisinopril tablet
Arrow-Losartan potassium & Hydrochlorthiazide hydrochlorthiazide; losartan tablet
Arrow-Meloxicam meloxicam tablet
Arrow-Morphine morphine tablet
Arrow-Ornidazole ornidazole tablet
Arrow-Quinapril quinapril tablet
Arrow-Roxithromycin roxithromycin tablet
Arrow-Sertraline sertraline tablet
Arrow-Simva simvastatin tablet
Arrow-Sumatriptan sumatriptan tablet
Arrow-Timolol timolol eye drops solution
Arrow-Tolterdine tolterdine tablet
Arrow-tramadol tramadol capsule
Ava 20 ED ethinylestradiol; levonorgestrel tablet
Ava 30 ED ethinylestradiol; levonorgestrel tablet
Azarga brinzolamide; timolol eye drops
Azopt brinzolamide eye drops
Beclazone beclometasone inhaler
Betoptic
Betoptic S
betaxolol eye drops
Bezalip bezafibrate tablet
Bicillin L-A benzathine benzylpenicillin injection
Cefotaxime cefotaxime injection
Cefoxitin Actavis cefoxitin injection
Cefuroxime cefuroxime injection
Concerta methylphenidate tablet
Cubicin daptomycin infusion
Cyclogyl cyclopentolate eye drops
DermAssist hydrocortisone cream
Diane-35 ED cyproterone; ethinylestradiol tablet
Differin adapalene cream
Differin adapalene gel
DP-Allopurinol allopurinol tablet
Duotrav timolol; travoprost eye drops
Flucon fluorometholone eye drops
Fluvax influenza vaccine polyvalent injection
Fortum ceftazidime injection
Glycophos sodium glycerophosphate infusion
Imbruvica ibrutinib capsule
Iopidine apraclonidine eye drops
Isoptin verapamil tablet
Keytruda pembrolizumab infusion
Lemtrada alemtuzumab infusion
Levemir insulin detemir injection
Levothyroxine levothyroxine tablet
Levrix levocetirizine tablet
Losartan Actavis losartan tablet
Metronidazole-Claris metronidazole infusion
Mirvaso brimonidine topical gel
Mydriacyl tropicamide eye drops solution
MyGran sumatriptan tablet
Naltraccord naltrexone tablet
NuvaRing ethinylestradiol; etonogestrel vaginal ring
Opdivo nivolumab infusion
Penicillin G Sodium benzylpenicillin injection
Pentacarinat pentamidine injection
Plaquenil hydroxychloroquine sulfate tablet
Praxbind idarucizumab injection
Rotarix rotavirus vaccine oral suspension
Rozex metronidazole topical gel
Rozex metronidazole cream
Simbrinza brimonidine; brinzolamide eye drops
Stocrin efavirenz tablet
Sutent sunitinib malate capsules
Targocid teicoplanin injection
Tazocin EF piperacillin; tazobactam injection
Travatan travoprost eye drops
Tygacil tigecycline injection
Uptravi selexipag tablet
Varilrix varicella vaccine injection
Yasmin drospirenone; ethinylestradiol tablet
Yaz drospirenone; ethinylestradiol tablet
Zapril cilazapril tablet
Zopiclone Actavis zopiclone tablet

Additions to the Medsafe Website from 27-31 March 2017


COMMITTEES
Medicines Adverse Reactions Committee
Opportunity to join the Medicines Adverse Reactions Committee

MEDICINES
Forms and Templates
Data sheet template (Word 17 KB, 2 pages)
This has been updated to included the standard wording on reporting suspected adverse reactions and the Poisons Centre phone number

PUBLICATIONS
Recent Official Information Act Releases
Request for MARC report on Risk Communication (Adobe PDF 11,786 KB, 48 pages)

SAFETY
Alert Communication
Andrographis paniculata – potential risk for allergic reactions

Dear Healthcare Professional Letters
Zelboraf (PDF 98KB, 2 pages) - Risk of Dupuytren's Contracture and Plantar Fascial Fibromatosis

Monitoring Communication
Animas Vibe Insulin Pump and Blood Glucose Analyser - ongoing issues with screen fade, cracked battery casing and other issues. 

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
ApoHealth Famciclovir ONCE famciclovir tablet
Champix varenicline tablet
Enbrel etanercept injection
Epclusa sofosbuvir; velpatasvir tablet
Galvus vildagliptin tablet
Harvoni ledipasvir; sofosbuvir tablet
Opdivo nivolumab infusion
Remicade infliximab injection
Sovaldi sofosbuvir tablet
Topamax topiramate tablet
capsule
Utrogestan progesterone capsule
Trileptal oxcarbazepine tablet
oral suspension
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
ApoHealth Famciclovir ONCE famciclovir tablet
Buspirone (Orion) buspirone tablet
Champix varenicline tablet
DBL Cefepime cefepime injection
DBL Cefotaxime Sodium cefotaxime sodium injection
DBL Flucloxacillin Sodium flucloxacillin sodium injection
DBL Piperacillin and Tazobactam piperacillin and tazobactam injection
Dilantin phenytoin sodium tablet
capsule
oral suspension
Epclusa sofosbuvir; velpatasvir tablet
Galvus vildagliptin tablet
Harvoni ledipasvir; sofosbuvir tablet
Hospira Cefazolin Sodium cefazolin sodium injection
Hospira Cefoxitin Sodium cefoxitin sodium injection
Hospira Ceftazidime ceftazidime injection
Hospira Ceftriaxone Sodium ceftriaxone sodium injection
Pregnyl chorionic gonadotrophin injection
Sirturo bedaquiline tablet
Sovaldi sofosbuvir tablet
Trileptal oxcarbazepine tablet
oral suspension
Utrogestan progesterone capsule

Additions to the Medsafe Website from 21-27 March 2017


SAFETY INFORMATION

Trans-Tasman Early Warning System — Alert Communication
Consumer Level Recall - EpiPen® (Adrenaline) 300 micrograms (mcg) Auto-Injector

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Pindolol pindolol tablet
Jurnista hydromorphone tablet
Rejuvenail ciclopirox nail lacquer
Sandostatin LAR (NEW FORMULATION) octreotide injection
Sylvant siltuximab infusion
Updated
Tradename Active ingredient(s) Dose form
Accuretic quinapril hydrochloride; hydrochlorothiazide tablet
Celecoxib Pfizer celecoxib capsule
Edurant rilpivirine tablet
Elonva corifollitropin alfa injection
Ibavyr ribavirin tablet
Levlen ED ethinylestradiol; levonorgestrel tablet
Microgynon 20 ED ethinylestradiol; levonorgestrel tablet
Microgynon 30 ED ethinylestradiol; levonorgestrel tablet
Microgynon 50 ED ethinylestradiol; levonorgestrel tablet
Microlut Levonorgestrel tablet
TMP trimethoprim tablet
Zelboraf vemurafenib tablet
DATA SHEETS
New
Tradename Active Ingredient(S) Dose Form
Sandostatin LAR (NEW FORMULATION) octreotide injection
Updated
Tradename Active ingredient(s) Dose form
Apo-Folic folic acid tablet
Apo-Nicotinic Acid nicotinic acid tablet
BiCNU carmustine injection
Brevinor 21 day
Brevinor 1 21 day
Brevinor 1 28 day
Norimin
ethinylestradiol; norethisterone tablet
Elonva corifollitropin alfa injection
Fluorescein SERB fluorescein injection
Humira adalimumab pen
injection
Ibavyr ribavirin tablet
Jurnista hydromorphone tablet
Levlen ED ethinylestradiol; levonorgestrel tablet
Loette ethinylestradiol; levonorgestrel tablet
Luvox fluvoxamine tablet
Microgynon 20 ED ethinylestradiol; levonorgestrel tablet
Microgynon 30 ED ethinylestradiol; levonorgestrel tablet
Microgynon 50 ED ethinylestradiol; levonorgestrel tablet
Microlut levonorgestrel tablet
Monofeme ethinylestradiol; leonorgestrel tablet
Opdivo nivolumab infusion
Xylocaine 1% with Adrenaline adrenaline; lidocaine injection


Additions to the Medsafe Website from 14-20 March 2017


PUBLICATIONS
Media Releases
Primodos

CONSUMER MEDICINE INFORMATION
New    
Tradename Active ingredient(s) Dose form
Enlafax XR venlafaxine capsule
Updated
Tradename Active ingredient(s) Dose form
Cefuroxime cefuroxime injection
Creon pancreatin capsule
Fortum ceftazidime injection
Isoptin verapamil tablet
Isoptin SR verapamil tablet
Marevan warfarin tablet
Xalkori crizotinib capsule
Xolair omalizumab injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Leflunomide leflunomide tablet
Enlafax XR venlafaxine capsule
Lodi amiodarone infusion
Updated
Tradename Active ingredient(s) Dose form
Apo-Pyridoxine pyridoxine tablet
Cefuroxime cefuroxime injection
Edurant rilpivirine tablet
Enbrel etanercept injection
Erwinase asparaginase injection
Ethinyloestradiol ethinylestradiol tablet
Fortum ceftazidime injection
Isoptin
Isoptin SR
verapamil tablet
Marevan warfarin tablet
Noxafil posaconazole injection
Reyataz atazanavir capsule
Sprycel dasatinib tablet
Xeomin botulinum toxin type a injection
Xolair omalizumab injection
Zelboraf vemurafenib tablet
Zinacef cefuroxime sodium injection
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