Revised:  12 February 2020

About Medsafe

What's New

Additions to the Medsafe Website from 23 to 27 January 2020

 

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Ventolin Syrup salbutamol syrup
Updated
Tradename Active ingredient(s) Dose form
Adriamycin doxorubicin injection
Alphamox amoxicillin capsule
Bridion sugammadex injection
Erlyand apalutamide tablet
Glizide gliclazide tablet
Lorstat atorvastatin tablet
Lucrin Depot leuprorelin injection
Nucala mepolizumab injection
Ropin ropinirole tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Atgam antithymocyte immunoglobulin injection
Augmentin amoxicillin; clavulanic acid tablet, suspension, injection
Furosemide-Baxter furosemide injection
Glizide gliclazide tablet
Herceptin trastuzumab infusion
Hydrea hydroxycarbamide capsule
Jaqinus tofacitinib tablet
Lorstat atorvastatin tablet
Lucrin Depot leuprorelin injection
Milrinone-Baxter milrinone injection
Onglyza saxagliptin tablet
Oratane isotretinoin capsule
Plenvu ascorbic acid; macrogols; potassium chloride; sodium chloride; sodium sulfate oral solution
Ra-Morph morphine oral solution
Ropin ropinirole tablet
Solian amisulpride oral solution, tablet
Ventolin Syrup salbutamol syrup

Additions to the Medsafe Website from 18 to 23 January 2020

Reminder that the Consultation on proposed changes to current warning and advisory statements for paracetamol closes on 31 January 2020

COMMITTEES
Medicines Adverse Reactions Committee
Minutes of the Medicines Adverse Reactions Committee Meeting held on 5 December 2019

SAFETY
Dear Healthcare Professional
Supply of Accuretic 10mg/12.5mg tablets in alternative (Canadian) artwork to New Zealand

Monitoring Communcation
Update - Everet (levetiracetam) - supply and potential seizure control issues for patients
Update - Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
PiperTaz Sandoz piperacillin; tazobactam injection
PipTaz Sandoz piperacillin; tazobactam injection
Updated
Tradename Active ingredient(s) Dose form
Atgam antithymocyte immunoglobulin injection
Cilicaine VK phenoxymethlpenicillin capsule
Isoptin verapamil injection, tablet
Keytruda pembrolizumab infusion
Nexavar sorafenib tablet
Nucala mepolizumab injection
Pimafucort hydrocortisone; natamycin; neomycin cream, ointment
Renagel sevelamer tablet
Sandostatin LAR octreotide injection
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Varivax varicella vaccine injection
Zyprexa olanzapine tablet, wafer, injection
Zyprexa Relprevv olanzapine injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Olopatadine (Teva) olopatadine eye drops
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Bimatoprost (Multichem) bimatoprost eye drops
Cilicaine procaine penicillin injection
Cilicaine VK phenoxymethlpenicillin capsule
DBL Diazepam diazepam injection
DBL Heparin Sodium BP heparin injection
Elelyso taliglucerase alfa injection
Habitrol nicotine chewing gum
Keytruda pembrolizumab infusion
Locacorten-Vioform clioquinol; flumetasone ear drops
Minims Cyclopentolate cyclopentolate eye drops
Nexavar sorafenib tablet
Nucala mepolizumab injection
Opdivo nivolumab infusion
Pimafucort hydrocortisone; natamycin; neomycin topical cream, ointment
PiperTaz Sandoz piperacillin; tazobactam injection
PipTaz piperacillin; tazobactam injection
Potassium Chloride in Glucose glucose; potassium chloride; sodium chloride infusion
Potassium Chloride in Sodium Chloride (Baxter) potassium chloride; sodium chloride infusion
Primene alanine; arginine; aspartic acid; cysteine; glutamic acid; glycine; histidine; isoleucine; leucine; lysine; methionine; ornithine; phenylalanine; proline; serine; taurine; threonine; tryptophan; tyrosine; valine infusion
Rapifen alfentanil injection
Sandostatin LAR octreotide injection
Sublimaze fentanyl injection
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Varivax varicella vaccine injection

Additions to the Medsafe Website from 19 November to 17 January 2020

Reminder that the Consultation on proposed changes to current warning and advisory statements for paracetamol closes on 31 January 2020
 
COMMITTEES
Medicines Adverse Reactions Committee
Agenda for the 180th Medicines Adverse Reactions Committee meeting - 5 December 2019
 
Medicines Classification Committee
Dates and Deadlines
Minutes of the 63rd meeting of the Medicines Classification Committee held in Wellington on 10 October 2019
 
MEDICINES
Marketing products which are not approved medicines
 
PUBLICATIONS
Media Releases
Medsafe Reinforces Advice on Lamotrigine
Medsafe issues patient advice on EpiPen JR
Medicines Classification Committee releases latest meeting minutes
Taking multiple medicines? Support the health care system by reporting suspected side effects this #MedSafetyWeek
 
Prescriber Update
Prescriber Update Volume 40 Number 4 dated December 2019
 
SAFETY
Alert Communication
EpiPen® Jr 150 mcg Adrenaline (epinephrine) Auto-Injector containing trace levels of Pralidoxime
Consent to distribute Cafergot tablets (ergotamine tartrate 1 mg + caffeine 100 mg) will be prohibited under Section 36 of the Medicines Act 1981 on 1 May 2020
 
Monitoring Communication
Update - Risk of infections with Prolia (denosumab)
Update - Tramadol and opioid effects in breastfeeding babies
Update on suspected adverse reaction reports to lamotrigine after changing brands
M2 Update – Isotretinoin and Obsessive Compulsive Disorder (OCD)

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Enstilar betamethasone; calcipotriol foam
Multihance gadobenic acid injection
Nucala mepolizumab injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Enstilar betamethasone; calcipotriol foam
Updated
Tradename Active ingredient(s) Dose form
Bridion sugammadex injection
DBL Dexamethasone Sodium Phosphate dexamethasone injection
Dexmethsone dexamethasone tablet
Erlyand apalutamide tablet
Eylea aflibercept injection
Mozobil plerixafor injection
Renagel sevelamer tablet
 

Additions to the Medsafe Website from 12 October-18 November 2019


CONSULTATION

Consultation on proposed changes to current warning and advisory statements for paracetamol

COMMITTEES
Medicines Adverse Reactions Committee
Minutes of the 179th Medicines Adverse Reactions Committee Meeting
MARC reports presented at the 179th Medicines Adverse Reactions Committee Meeting

MEDICINES
GMP Certified Contract Testing Laboratories

Forms
Product Status Change Request Form (effective from November 2019) (Microsoft Word 21KB)


Guidelines and Codes
Part 2: Obtaining approval for new and changed medicines (PDF 1220KB, 65 Pages)
Appendix 8: Data Requirements for New Medicine Applications (PDF 212 KB, 26 pages)

SAFETY
Alert Communication
Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)
Consumer level recall of one lot of Avonex Pen 30mcg in 0.5mL, Lot 1422362

Monitoring Communication
M2 Possible risk of vasculitis with dabigatran (Pradaxa)
Losartan approved medicines supplied in New Zealand not affected by recalls overseas
Review of chemically synthesised active pharmaceutical ingredients for presence of nitrosamine impurity
Suspected adverse reaction reports to lamotrigine after changing brands
Everet (levetiracetam) - supply and potential seizure control issues for patients
Update 7 November 2019 - Breast Implants and anaplastic large cell lymphoma

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Baclofen (Medsurge) baclofen injection
Besponsa inotuzumab ozogamicin injection
Erlyand apalutamide tablet
Imfinzi durvalumab infusion
Maxigesic IV ibuprofen, paracetamol infusion
Odefsey emtricitabine; rilpivirine; tenofovir tablet
Rydapt midostaurin capsule
Teicoplanin Mylan carbamazepine injection
Teriflunomide Sandoz teriflunomide Tablet
Tranexamic Acid tranexamic acid injection
Updated
Tradename Active ingredient(s) Dose form
Anthisan mepyramine topical cream
Bicillin L-A benzathine benzylpenicillin tetrahydrate injection
Cipflox ciprofloxacin tablet
Cipflox ciprofloxacin infusion
Citalopram citalopram tablet
Enlafax XR venlafaxine capsule
Escitalopram Apotex escitalopram tablet
Gardasil 9 human papillomavirus vaccine injection
Humira adalimumab injection
Keytruda pembrolizumab infusion
Loxalate escitalopram tablet
Loxamine paroxetine tablet
Lynparza olaparib tablet
Lynparza olaparib capsule
Mekinist trametinib tablet
Prevenar 13 pneumococcal vaccine injection
RIXUBIS nonacog gamma injection
Seroquel quetiapine tablet
Spiriva Respimat tiotropium solution for inhalation
Tafinlar dabrafenib capsule
Tobi tobramycin solution for inhalation
Tranexamic Acid tranexamic acid tablet
Zoledronic Acid Mylan zoledronic acid infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Besponsa inotuzumab ozogamicin injection
Buprenorphine Naloxone BNM buprenorphine; naloxone tablet
Cyclizine Lactate cyclizine injection
Erlyand apalutamide tablet
Glucose 5% Freeflex glucose infusion
Imfinzi durvalumab infusion
Maxigesic IV ibuprofen; paracetamol infusion
Modafinil modafinil tablet
Precedex Ready to Use dexmedetomidine injection
Rydapt midostaurin capsule
Teicoplanin Mylan teicoplanin injection
Teriflunomide Sandoz teriflunomide tablet
Updated
Tradename Active ingredient(s) Dose form
Arrow - Norfloxacin norfloxacin tablet
Atropine BP atropine injection
Bicillin L-A benzathine benzylpenicillin tetrahydrate injection
Bisolvon Dry dextromethorphan oral solution, pastille
Bortezomib (Dr Reddy's) bortezomib injection
Cipflox ciprofloxacin tablet, infusion
Citalopram citalopram tablet
Clomazol clotrimazole vaginal cream
Compound Sodium Lactate (Hartmann's Solution) and 5% Glucose glucose, potassium chloride, sodium chloride, calcium chloride dihydrate, sodium lactate infusion
DBL Octreotide octreotide injection
DBL Vincristine Sulfate vincristine injection
Enlafax XR venlafaxine capsule
Escitalopram Apotex escitalopram tablet
Flagyl metronidazole suppository, oral suspension
Gardasil 9 human papillomavirus vaccine injection
Humira adalimumab injection
Ibrance palbociclib capsule
Ketalar ketamine injection
Keytruda pembrolizumab infusion
Kyprolis carfilzomib infusion
Loxalate escitalopram tablet
Loxamine paroxetine tablet
Lynparza olaparib tablet
Lynparza olaparib capsule
Mekinist trametinib tablet
Novatretin acitretin capsule
Odefsey emtricitabine; rilpivirine; tenofovir tablet
Oratane isotretinoin capsule
Parecoxib (Neo Health) parecoxib injection
Potassium chloride (Astra) potassium chloride injection
Prevenar 13 pneumococcal vaccine injection
Priorix measles vaccine; mumps vaccine; rubella vaccine injection
RIXUBIS nonacog gamma injection
Sandimmun ciclosporin infusion
Soliris eculizumab infusion
Spiriva Respimat tiotropium solution for inhalation
Sustanon testosterone injection
Tafinlar dabrafenib capsule
Tivicay dolutegravir tablet
Tobi tobramycin solution for inhalation
Uptravi selexipag tablet
Uromitexan mesna tablet and injection
Voltaren Rapid diclofenac tablet
Yervoy ipilimumab infusion
Zoledronic Acid Mylan zoledronic acid infusion
Zoloft sertraline tablet
Zyprexa olanzapine tablet
Zyprexa IM olanzapine injection
Zyprexa Relprevv olanzapine injection
Zyprexa Zydis olanzapine wafer
 
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