Revised:  14 November 2019

About Medsafe

What's New

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
 

Additions to the Medsafe Website from 6-11 October 2019


ABOUT MEDSAFE
Medsafe Office Closure Christmas/New Year 2019/2020

COMMITTEES
Medicines Assessment Advisory Committee
Administrative Process
Terms of Reference

DEVICES
Medical Device Adverse Event Reporting

SAFETY
Alert Communication

Medsafe is issuing a warning that Valentus SlimROAST Optimum Dark Roast Coffee should not be consumed - statement under section 98 of the Medicines Act 1981

Surgical Mesh Implants - Adverse Event Reporting and Monitoring - Link to the latest October 2019 report

 

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Coumadin Warfarin tablet
Dukoral Cholera vaccine oral suspension
Humira Adalimumab injection
Modavigil Modafinil tablet
Norpress Nortriptyline tablet
Tazocin EF Piperacillin; Tazobactam injection
Vancomycin Vancomycin infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Benzatropine (Phebra) Benzatropine injection
Updated
Tradename Active ingredient(s) Dose form
Carboplatin (Pfizer) Carboplatin injection
Coumadin Warfarin tablet
DBL Carboplatin Carboplatin injection
Humira Adalimumab injection
Imuran Azathioprine injection
Imuran Azathioprine tablet
Lanvis Tioguanine tablet
Modavigil Modafinil tablet
Neostigmine Methylsulphate Neostigmine injection
Norpress Nortriptyline tablet
Puri-nethol Mercaptopurine tablet
Serenace Haloperidol tablet, injection, oral solution
Suboxone Buprenorphine; Naloxone tablet
Suxamethonium Chloride BP Suxamethonium injection
Vancomycin Vancomycin infusion
 

Additions to the Medsafe Website from 1-4 October 2019


Consultation
Outcome of consultation on the changes to the prescribing restrictions of riluzole

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Aspen Ciprofloxacin ciprofloxacin injection
Updated
Tradename Active ingredient(s) Dose form
Diclofenac Sandoz diclofenac tablet
Exjade deferasirox tablet
Flucil flucloxacillin injection
Fluorouracil Ebewe fluorouracil injection
Kyprolis carfilzomib infusion
Levothyroxine levothyroxine tablet
Loxalate escitalopram tablet
Nyefax Retard nifedipine tablet
Picosalax citric acid; magnesium oxide; sodium picosulfate oral solution
Rapamune sirolimus oral solution, tablet
Temaccord temozolomide capsule
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
DBL Bortezomib bortezomib injection
Hospira Bortezomib bortezomib injection
Updated
Tradename Active ingredient(s) Dose form
Aciclovir-Baxter aciclovir infusion
Aspen Ciprofloxacin ciprofloxacin injection
DBL Docetaxel docetaxel injecton
Diclofenac Sandoz diclofenac tablet
Droleptan droperidol injection
Fentanyl (AstraZeneca) fentanyl injection
Flucil flucloxacillin injection
Levothyroxine levothyroxine tablet
Melorex meloxicam tablet
Nyefax Retard nifedipine tablet
Phenasen arsenic trioxide infusion
Picosalax citric acid; magnesium oxide; sodium picosulfate oral solution
Rapamune sirolimus oral solution, tablet
Revlimid lenalidomide capsule
Sensipar cinacalcet tablet
Sodium Chloride (Baxter) Sodium Chloride infusion
Temaccord temozolomide capsule
Thalomid thalidomide capsule
Typhim Vi salmonella typhi vi polysaccharide injection
Tysabri natalizumab infusion
Zinacef cefuroxime injection, infusion

Additions to the Medsafe Website from 17 August – 30 September 2019


COMMITTEES
Medicines Adverse Reactions Committee
Agenda for the 179th meeting of the Medicines Adverse Reactions Committee

Committee Process
Update of Committee Members

PUBLICATIONS
Prescriber Update Vol.40 No.3 5 September 2019

SAFETY
Alert Communication
Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)
 
Dear Healthcare Professional Letter
MMR II Vaccine - Additional supply of MMR II measles, mumps and rubella vaccine: differences in labelling and package inserts
 
Monitoring Communication
Update - Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Atorvastatin Pfizer Atorvastatin tablet
BecloClear 100 Beclometasone nasal spray
Biktarvy Bictegravir; Emtricitabine; Tenofovir tablet
Ibuprofen SR BNM Ibuprofen tablet
Isentress Raltegravir tablet
Lynparza Olaparib tablet
Mavenclad Cladribine tablet
Onivyde Irinotecan infusion
Rivastigmine Rivastigmine patch
Solifenacin Sandoz Solifenacin tablet
Tobramycin Wockhardt Tobramycin inhalation solution
Updated
Tradename Active ingredient(s) Dose form
Adacel Diphtheria vaccine; Pertussis vaccine; Tetanus vaccine injection
Adenuric Febuxostat tablet
Albey Wasp venom protein injection
Alphamox Amoxicillin Suspension
Alustal Allergens injection
Apo-Furosemide Furosemide tablet
Atrovent Ipratropium inhaler
Avonex Interferon beta injection
Condyline Podophyllotoxin topical solution
Descovy Emtricitabine; Tenofovir tablet
Doxorubicin Ebewe Doxorubicin injection
Eliquis Apixaban tablet
Epirubicin Ebewe Epirubicin injection
Ferodan Ferrous sulfate oral solution
Firazyr Icatibant injection
Flucloxacillin (AFT) Flucloxacillin capsule, oral solution
Fluox Fluoxetine capsule, tablet
Fucicort Betamethasone; Fusidic acid topical cream
Gilenya Fingolimod capsule
Lipitor Atorvastatin tablet
Maltofer Iron polymaltose tablet, syrup
Neo-Mercazole Carbimazole tablet
Opdivo Nivolumab infusion
Ozole Fluconazole capsule
Paclitaxel Ebewe Paclitaxel injection
Pharmorubicin Epirubicin injection
Pharmorubicin Epirubicin injection
Pomalyst Pomalidomide capsule
Puregon Follitropin injection
Revolade Eltrombopag tablet
RotaTeq Rotavirus vaccine oral solution
Sativex Cannabidiol; Tetrahydrocannabinol Oromucosal Spray
Simvastatin Mylan Simvastatin tablet
Tenofovir Disoproxil Emtricitabine Efavirenz Mylan Efavirenz; Emtricitabine; Tenofovir tablet
Tykerb Lapatinib tablet
Uptravi Selexipag tablet
Veletri Epoprostenol injection
Zarator Atorvastatin tablet
Zavesca Miglustat capsule
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Furosemide Furosemide tablet
BecloClear 100 Beclometasone nasal spray
Biktarvy Bictegravir; Emtricitabine; Tenofovir tablet
Ceftazidime-AFT Ceftazidime injection
Cinacalcet Devatis Cinacalcet tablet
Ibuprofen SR BNM Ibuprofen tablet
Lynparza Olaparib tablet
Mavenclad Cladribine tablet
Mebeverine Generic Partners Mebeverine tablet
Melatonin Generic Partners Melatonin tablet
Onivyde Irinotecan infusion
Solifenacin Sandoz Solifenacin tablet
Tobramycin Wockhardt Tobramycin inhalation solution
Updated
Tradename Active ingredient(s) Dose form
0.9% Sodium Chloride Baxter Sodium Chloride infusion
Actair Dermatophagoides farinae allergen extract; Dermatophagoides pteronyssinus allergen extract tablet
Adacel Diphtheria vaccine; Pertussis vaccine; Tetanus vaccine injection
Adenuric Febuxostat tablet
Agrylin Anagrelide capsule
Alphamox Amoxicillin suspension
Alustal Allergens injection
Anzatax Paclitaxel injection
Atrovent Ipratropium inhaler
Bupivacaine-Baxter Bupivacaine injection
Canesoral DUO Clotrimazole; Fluconazole combination (capsule and cream)
Cefuroxime Devatis Cefuroxime injection
Chlorvescent Effervescent Potassium bicarbonate; Potassium carbonate; Potassium chloride tablet
DBL Cefotaxime Sodium Cefotaxime Sodium injection
DBL Methotrexate Methotrexate injection
DBL Morphine Sulfate Morphine Sulfate injection
DBL Morphine Tartrate Morphine Tartrate injection
DBL Phenytoin Phenytoin injection
DBL Promethazine hydrochloride Promethazine injection
Definity Perflutren injection
Descovy Emtricitabine; Tenofovir tablet
Diclofenac Diclofenac tablet
Doxorubicin Ebewe Doxorubicin injection
Eliquis Apixaban tablet
Enbrel Etanercept injection
Epclusa Sofosbuvir; Velpatasvir tablet
Epclusa Sofosbuvir; Velpatasvir tablet
Epirubicin Ebewe Epirubicin injection
Ethics Enalapril Enalapril tablet
Etopophos Etoposide injection
Ferodan Ferrous sulfate oral solution
Ferriprox Deferiprone oral solution, tablet
Firazyr Icatibant injection
Flamazine Sulfadiazine silver cream
Flucloxacillin (AFT) Flucloxacillin capsule, oral solution
Fluox Fluoxetine capsule, tablet
Gilenya Fingolimod capsule
Glucose and Sodium Chloride (Baxter) Glucose; Sodium chloride infusion
Harvoni Ledipasvir; Sofosbuvir tablet
Hiberix Haemophilus influenzae type b vaccine injection
Hydrea Hydroxycarbamide capsule
Imbruvica Ibrutinib capsule
Lipitor Atorvastatin tablet
Lonquex Lipegfilgrastim injection
Lumigan PF Bimatoprost eye drops
Maltofer Iron polymaltose tablet, syrup
Marcain Bupivacaine injection
Marcain with adrenaline Adrenaline; Bupivacaine injection
Medrol Methylprednisolone tablet
Metvix Methyl aminolevulinate cream
Minims Chloramphenicol Chloramphenicol eye drops solution
Minomycin Minocycline capsule
Mobic Meloxicam tablet
Movicol Junior Macrogols; Potassium chloride; Sodium bicarbonate; Sodium chloride oral solution
Mycostatin Nystatin topical cream
Neo-Mercazole Carbimazole tablet
Neutrafluor Sodium fluoride toothpaste
Nimenrix Meningococcal vaccine injection
Ofev Nintedanib capsule
Omnipaque Iohexol injection
Opdivo Nivolumab infusion
Opsumit Macitentan tablet
Oralair Grass pollen extract tablet
Ozole Fluconazole capsule
Paclitaxel Ebewe Paclitaxel injection
Panadol Osteo Paracetamol tablet
Parecoxib JPL Parecoxib injection
Plenvu Ascorbic acid; Macrogols; Potassium chloride; Sodium chloride; Sodium sulfate oral solution
Pomalyst Pomalidomide capsule
Pradaxa Dabigatran capsule
Pregabalin Pfizer Pregabalin capsule
Pregnyl Chorionic gonadotrophin injection
Priorix-Tetra Measles vaccine; Mumps vaccine; Rubella vaccine; Varicella vaccine injection
Prolia Denosumab injection
Puregon Follitropin injection
Repatha Evolocumab injection
Revolade Eltrombopag tablet
RiaSTAP Fibrinogen injection
RotaTeq Rotavirus vaccine oral solution
Rubifen Methylphenidate tablet
Sevoflurane Sevoflurane votatile liquid for inhalation
Simvastatin Mylan Simvastatin tablet
Sovaldi Sofosbuvir tablet
Sprycel Dasatinib tablet
Suprane Desflurane volatile liquid for inhalation
Tenofovir Disoproxil Emtricitabine Efavirenz Mylan Efavirenz; Emtricitabine; Tenofovir tablet
Tracleer Bosentan tablet
Tranexamic Acid Juno Tranexamic acid injection
Tykerb Lapatinib tablet
Uptravi Selexipag tablet
Varilrix Varicella vaccine injection
Veletri Epoprostenol injection
Vepesid Etoposide capsule
Vosevi Sofosbuvir; Velpatasvir; Voxilaprevir tablet
Vosevi Sofosbuvir; Velpatasvir; Voxilaprevir tablet
Xiaflex Collagenase clostridium histolyticum injection
Yervoy Ipilimumab injection
Zarator Atorvastatin tablet
Zavesca Miglustat capsule
Zytiga Abiraterone tablet

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