About Medsafe

Revised: 5 November 2018

What's New

Additions to the Medsafe Website from 22-26 October 2018


COMMITTEES
Medicines Adverse Reaction Committee
175th meeting - 13 September 2018

CONSULTATIONS
Proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products

MEDIA RELEASES
Dangers of purchasing medicines online highlighted

CONSUMER MEDICINE INFORMATION
New
Tradename Dose form Active ingredient(s)
Clonidine Hydrochloride injection clonidine
Dortimopt eye drops solution dorzolamide; timolol
Giotrif tablet afatinib
Updated
Tradename Dose form Active ingredient(s)
Logem tablet lamotrigine
Oxis turbuhaler formoterol
Seebri capsule glycopyrronium bromide
Zoledronic acid Mylan infusion zoledronic acid
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Dortimopt eye drops solution dorzolamide; timolol
Giotrif tablet afatinib
Updated
Tradename Active ingredient(s) Dose form
Actemra infusion, injection tocilizumab
Azamun tablet azathioprine
Cytarabine injection cytarabine
Depo-Medrol injection methylprednisolone
Ikorel tablet nicorandil
Logem tablet lamotrigine
Mitozantrone injection mitoxantrone
Oxis turbuhaler formoterol
Rilutek tablet riluzole
Seebri capsule glycopyrronium bromide
Zemaira infusion alpha1-proteinase inhibitor
Zoledronic acid Mylan infusion zoledronic acid
Zoledronic acid infusion zoledronic acid


Additions to the Medsafe Website from 16-19 October 2018


COMMITTEES
Medicines Assessment Advisory Committee
Summary of recommendations from the out-of-session meeting from 29 August to 1 October 2018
Vacancies

MEDICINES
Influenza Vaccine Composition in 2019

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Vancomycin (Mylan) vancomycin infusion
Updated
Tradename Active ingredient(s) Dose form
Adenocor adenosine injection
Dynastat parecoxib injection
Noradrenaline (BNM) noradrenaline injection
Nozinan levomepromazine tablet, injection
Oxycodone (BMN) oxycodone tablet
Qvar beclometasone inhaler
Stemetil prochlorperazine injection
Trental pentoxifylline tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Perindopril perindopril tablet
Vancomycin (Mylan) vancomycin infusion
Updated
Tradename Active ingredient(s) Dose form
Alanase beclometasone nasal spray
Lamivudine/Zidovudine/Alphapharm lamivudine; zidovudine tablet
Neostigmine Methylsulphate (AstraZeneca) neostigmine injection
Qvar beclometasone inhaler
Soliris eculizumab infusion
 


Additions to the Medsafe Website from 11-15 October 2018

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Amlodipine tablet Amlodipine
Apo-Primidone tablet Primidone
Bisolvon Dry pastilles Dextromethorphan
Esmeron injection Rocuronium
Leuprorelin Sandoz implant Leuprorelin
Mylan Midazolam injection Rosuvastatin
Updated
Tradename Active ingredient(s) Dose form
Abraxane injection Paclitaxel
Alanase nasal spray Beclometasone
Apo-Diltiazem CD capsule Diltiazem
Betnovate skin lotion Betamethasone; Neomycin
Erbitux infusion Cetuximab
Eumovate topical cream Clobetasone; Neomycin
Galvumet tablet Metformin; Vildagliptin
Genotropin injection Somatropin
Maviret tablet Glecaprevir; Pibrentasvir
Methoblastin tablet Methotrexate
Miacalcic injection Calcitonin
Noflam tablet Naproxen
Prezista tablet Darunavir
Seroquel tablet Quetiapine
Sporanox capsule Itraconazole
Synacthen Depot injection Tetracosactide
Temaccord capsule Temozolomide
Zapril tablet Cilazapril
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Bisolvon Dry pastilles Dextromethorphan
Bisolvon Dry oral solution Dextromethorphan
Caspofungin (Martindale) infusion Carbaril
Mylan Midazolam injection Rosuvastatin
Scandonest 2% Special Solution injection Mepivacaine
Updated
Tradename Active ingredient(s) Dose form
Abraxane injection Paclitaxel
Actemra infusion, injection Tocilizumab
Adenocor injection Adenosine
Alanase nasal spray Beclometasone
Apo-Amlodipine tablet Amlodipine
Apo-Azithromycin tablet Azithromycin
Apo-Diltiazem CD Diltiazem Diltiazem
Apo-Primidone tablet Primidone
Betnovate skin lotion Betamethasone; Neomycin
Buscopan tablet, injection Hyoscine
Clobex shampoo Clobetasol
DBL - Hyoscine injection Vincristine
Dexmethsone tablet Dexamethasone
Differin cream Adapalene
Differin gel Adapalene
Dynastat injection Parecoxib
Eloxatin infusion Oxaliplatin
Erbitux infusion Cetuximab
Erivedge capsule Vismodegib
Esmeron injection Rocuronium
Eumovate topical cream Clobetasone; Neomycin
Evoltra injection Clofarabine
Fasturtec infusion Rasburicase
Galvumet tablet Metformin; Vildagliptin
Havrix Junior injection, suspension Hepatitis A vaccine
Hiberix injection Haemophilus influenzae type b vaccine
Intal Forte inhaler Cromoglicic acid
Lasix infusion, oral solution Furosemide
Lidocaine-Claris lidocaine Lidocaine
Maviret tablet Glecaprevir; Pibrentasvir
Medrol tablet Methylprednisolone
Miacalcic injection Calcitonin
Naramig tablet Naratriptan
Nimenrix injection Neisseria meningitidis vaccine; Tetanus vaccine
Noflam tablet Naproxen
Nozinan injection, tablet Levomepromazine
Panafen Plus Codeine; Ibuprofen Ibuprofen
Paracetamol Kabi injection Paracetamol
Paracetamol-AFT infusion Paracetamol
pdp-Pyrazinamide tablet Pyrazinamide
Peptisoothe syrup Ranitidine
Prezista tablet Darunavir
Primacor injection Milrinone
Priorix injection Measles vaccine; Mumps vaccine; Rubella vaccine
Qvar aerosol inhaler Beclometasone
Renagel tablet Sevelamer
Revlimid capsule Lenalidomide
Reyataz capsule Atazanavir
Sporanox capsule Itraconazole
Stemetil injection, suppository Prochlorperazine
Synacthen injection Tetracosactide
Synacthen Depot injection Tetracosactide
Temaccord capsule Temozolomide
Trental tablet Pentoxifylline
Xgeva injection Denosumab
Zapril tablet Cilazapril
Zeldox capsule Ziprasidone
Zeldox IM injection Ziprasidone
Zinacef injection, infusion Cefuroxime
Zusdone capsule Ziprasidone

Additions to the Medsafe Website from 17 September – 10 October 2018


ABOUT MEDSAFE
Vacancies
Advisor (Science) Wellington

COMMITTEES
Medicines Adverse Reaction Committee
Medicines Adverse Reaction Committee - Vacancy

Medicines Classification Committee
Medicines Classification Committee - Dates and Deadlines
Medicines Classification Committee - Comments on agenda for the 61st Medicines Classification Committee meeting 27 September 2018

COMPLIANCE
Sale of medicines and medical devices via social media

INFORMATION FOR INDUSTRY
Current Guidelines on the Regulation of Therapeutic Products in New Zealand
Part 4: Manufacture of medicines (PDF 1058 KB, 13 pages)

MEDICAL DEVICES
Surgical Mesh
Actions Taken by Medsafe
Overseas Actions and Reviews
Surgical Mesh Implants - Implementation of Government Response to Report of the Health Committee on Petition 2011/102

MEDIA RELEASES
Medsafe statement: Pharmacy Licencing Update

RECALL
Coaguchek (PDF 559 KB, 8 pages)

SAFETY ALERT
Volulyte and Voluven (PDF 821 KB, 2 pages)

CONSUMER MEDICINE INFORMATION
Updated
Tradename Dose form Active ingredient(s)
Exjade tablet deferasirox
FEIBA NF injection factor viii inhibitor bypassing fraction
Invega tablet paliperidone
Invega Sustenna suspension paliperidone
Invega Trinza suspension paliperidone
Isotane capsule isotretinoin
Risperdal tablet, oral solution risperidone
Risperdal Consta injection risperidone
DATA SHEETS
New
Tradename Dose form Active ingredient(s)
Neupro patch Rotigotine
Updated
Tradename Dose form Active ingredient(s)
Clinpro toothpaste sodium fluoride
Exjade tablet deferasirox
FEIBA NF injection factor viii inhibitor bypassing fraction
Genotropin injection somatropin
Isotane capsule isotretinoin
Nitrolingual spray glyceryl trinitrate