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Revised: 19 June 2017

What's New


Additions to the Medsafe Website from 12-16 June 2017


Committees
Medicines Assessment Advisory Committee
Agenda for the 105th meeting of the Medicines Assessment Advisory Committee - 27 June 2017

Medicines
Forms and Templates
These 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.

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Actemra tocilizumab injection
Acupan nefopam tablet
ADT-Booster diphtheria vaccine; tetanus vaccine injection
Afinitor everolimus tablet
Antinaus (OTC) prochlorperazine maleate tablet
Antinaus (Prescription) prochlorperazine maleate tablet
Ativan lorazepam tablet
Bydureon exenatide injection
Celecoxib Pfizer celecoxib capsules
Champix varenicline tablet
Escitalopram-Apotex escitalopram tablet
Fucidin fusidic acid tablet
Gliolan aminolevulinic acid oral solution
Invega Sustenna paliperidone injection
Invega Trinza paliperidone injection
Keytruda pembrolizumab infusion
Lamivudine 150mg Zidovudine 300 mg Alphapharm lamivudine; zidovudine tablet
Naramig naratriptan tablet
Normison temazepam tablet
Paxam clonazepam tablet
Picato 0.015% w/w ingenol mebutate gel
Picato 0.05% w/w ingenol mebutate gel
Quetapel quetiapine tablet
Risperdal risperidone tablet
oral solution
Rulide D roxithromycin tablet
Sertraline Actavis sertraline tablet
Ventavis iloprost inhalation
Zarontin ethosuximide syrup
capsule
Zetop cetirizine tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
0.9% sodium chloride (Baxter) sodium chloride infusion
5% Glucose (Baxter) glucose infusion
Actemra tocilizumab infusion
injection
Acupan nefopam tablet
ADT-Booster diphtheria vaccine; tetanus vaccine injection
Afinitor everolimus tablet
Antinaus prochlorperazine maleate tablet
Apo-Moclobemide moclobemide tablet
Ativan lorazepam tablet
Bydureon exenatide injection
Cetrotide cetrorelix injection
Cilicaine procaine penicillin injection
Dexamphetamine Sulphate dexamfetamine tablet
Diclofenac (Dr Reddy's) diclofenac tablet
Enalapril (Ethics) enalapril tablet
Escitalopram (Apotex) escitalopram tablet
Feiba NF factor VIII inhibitor bypassing fraction injection
Invega paliperidone tablet
Invega Sustenna paliperidone injection
Invega Trinza paliperidone injection
Jakavi ruxolitinib tablet
Ketamine-Claris ketamine injection
Keytruda pembrolizumab infusion
Lamivudine 150mg Zidovudine 300 mg Alphapharm lamivudine; zidovudine tablet
Lithium Carbonate lithium capsule
Marcain Plain
Marcain with adrenaline
adrenaline
adrenaline; bupivacaine
injection
Metoclopramide Actavis metoclopramide tablet
Midazolam-Claris midazolam injection
Normison temazepam tablet
Nystatin (Multichem) nystatin suspension
Omeprazole (Dr Reddy's) omeprazole capsule
Paxam clonazepam tablet
Penthrox Volatile methoxyflurane liquid for inhalation
Plaquenil hydroxychloroquine tablet
Praxbind idarucizumab injection
Priorix measles vaccine; mumps vaccine; rubella vaccine injection
Provive propofol injection
Provive MCT-LCT propofol injection
Quetapel quetiapine tablet
Risperdal risperidone tablet
oral solution
Risperdal Consta risperidone injection
Rulide D roxithromycin tablet
Solian amisulpride tablet
oral solution
Sutent sunitinib capsule
Tropisetron-AFT tropisetron injection
Ventavis iloprost solution for inhalation
Vermox mebendazole tablet
Vermox mebendazole suspension
Vermox Choc Chews mebendazole tablet
Voriconazole (Generic Partners) voriconazole tablet
injection
Zarontin ethosuximide syrup
capsule
Zepatier elbasvir; grazoprevir tablet
Zista cetirizine hydrochloride tablet
 


Additions to the Medsafe Website from 6-12 June 2017

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Androderm Testosterone transdermal patch
Arrow - Norfloxacin Norfloxacin tablet
Celecoxib Pfizer Celecoxib capsules
Chlorafast Chloramphenicol eye drops solution
Clozaril Clozapine tablet
Ibavyr Ribavirin tablet
Naprosyn SR Naproxen tablet
Parnate Tranylcypromine tablet
Sebivo Telbivudine tablet
Viekira Pak Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir combination product
Viekira Pak-RBV Dasabuvir; Ombitasvir; Paritaprevir; Ribavirin; Ritonavir combination product
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Androderm Testosterone transdermal patch
Aranesp Darbepoetin alfa injection
Arrow - Norfloxacin Norfloxacin tablet
Avastin Bevacizumab infusion
Chlorafast Chloramphenicol eye drops solution
Clozaril Clozapine tablets
Clustran Sumatriptan injection
Gliolan Aminolevulinic acid oral solution
Naprosyn SR Naproxen tablet
Proleukin Aldesleukin injection
Sebivo Telbivudine tablet
Sertraline Actavis Sertraline tablet
Trusopt Dorzolamide eye drops
Videx EC Didanosine capsule
Viekira Pak Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir combination product
Viekira Pak-RBV Dasabuvir; Ombitasvir; Paritaprevir; Ribavirin; Ritonavir combination product
Xylocaine
Xylocaine with adrenaline
Lidocaine
Adrenaline; Lidocaine
injection
Zetop Cetirizine tablet
 

Additions to the Medsafe Website from 10 May-4 June 2017


COMMITTEES
Medicines Adverse Reactions Committee 
Agenda for the 170th Medicines Adverse Reactions Committee meeting - 8 June 2017

CONSULTATIONS
Outcome of consultation on addition of warning statements on labels of topical miconazole containing medicines available without prescription

Outcome of consultation on proposal to change the warning statement on labels of OTC loratadine and desloratadine medicines

DEVICES
Health Committee Recommendations and Timeline for Implementation re Surgical Mesh - has been updated

Adverse Event Reporting – has been updated

MONITORING COMMUNICATION
Direct-acting antiviral (DAA) regimens and liver failure

PUBLICATIONS
Prescriber Update 38(2) June 2017

Recent Media Releases
Hormonal Testing Preparations
Sentence handed down after steroid operation uncovered

SAFETY
How to Report a Problem has been updated

Overview of how Medsafe manages medical device adverse event reports and reports of medical device quality issues has been updated

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Anoro Ellipta Umeclidinium; Vilanterol powder for inhalation
Apo-Imiquimod Imiquimod cream
Arrow-Venlafaxine XR Venlafaxine tablet
Arrow-Roxithromycin Roxithromycin tablet
Arrow-Simva Simvastatin tablet
Ava 20 ED Ethinylestradiol; Levonorgestrel tablet
Ava 30 ED Ethinylestradiol; Levonorgestrel tablet
Betagan Levobunolol eye drops solution
Clonidine Transdermal System USP Clonidine patch
Dermol Clobetasol scalp lotion
Dermol Clobetasol cream
ointment
EpiPen Adrenaline injection
EpiPen Junior Adrenaline injection
Hypam Triazolam tablet
Incruse Ellipta Umeclidinium powder for inhalation
Kaletra Lopinavir; Ritonavir oral solution
tablet
Keytruda Pembrolizumab infusion
Mersyndol Codeine; Doxylamine; Paracetamol tablet
Minims Cyclopentolate hydrochloride Cyclopentolate eye drops solution
Minims Prednisolone Sodium phosphate eye drops solution
Mylan Atenolol Atenolol tablet
Neulactil Periciazine tablet
Norvir Ritonavir tablet
oral solution
Paracetamol and Codeine (Relieve) Paracetamol; Codeine tablet
Rilutek Riluzole tablet
Rivotril Clonazepam injection
oral solution
Tramal Tramadol oral drops
oral solution
Tramal Tramadol capsule
injection
Tramal SR Tramadol tablet
Zeffix Lamivudine oral solution
Zepatier Elbasvir; Grazoprevir tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Cefazolin-AFT Cefazolin tablet
Deolate Terbinafine tablet
Updated
Tradename Active ingredient(s) Dose form
Anoro Ellipta Umeclidinium; Vilanterol powder for inhalation
Aranesp Darbepoetin alfa injection
Citanest Plain Prilocaine injection
Clexane Enoxaparin sodium injection
Clonidine Transdermal System USP Clonidine patch
DBL Docetaxel Doxetaxel tablet
Dermol Clobetasol scalp lotion
Dermol Clobetasol cream
ointment
Diprivan Emulsion Propofol injection
Hemosol B0 Calcium chloride; Lactic acid; Magnesium chloride; Sodium bicarbonate; Sodium chloride dialysis solution
Hizentra Normal immunoglobulin injection
Hydrocortisone 1% PSM Hydrocortisone cream
Hypam Triazolam tablet
Incruse Ellipta Umeclidinium powder for inhalation
Kaletra Lopinavir; Ritonavir oral solution
tablet
Keytruda Pembrolizumab infusion
Mersyndol Codeine; Doxylamine; Paracetamol tablet
Metchek Metformin tablet
Methoblastin Methotrexate tablet
Minims Cyclopentolate hydrochloride Cyclopentolate eye drops solution
Minims Prednisolone Sodium phosphate eye drops solution
Mitozantrone Ebewe Mitoxantrone injection
Mylan Atenolol Atenolol tablet
Nardil Phenelzine tablet
Naropin with Fentanyl Fentanyl; Ropivacaine infusion
Neostigmine Methylsulphate Neostigmine injection
Neostigmine methylsulphate (Hameln) Neostigmine injection
Norvasc Amlodipine besilate tablet
Norvir Ritonavir tablet
oral solution
Ondanaccord Ondansetron injection
OxyNorm Oxycodone injection
Paracetamol and Codeine (Relieve) Paracetamol; Codeine tablet
Phoxilium Calcium chloride; Dibasic sodium phosphate; Magnesium chloride; Potassium chloride; Sodium bicarbonate; Sodium chloride dialysis solution
Pomalyst Pomalidomide capsule
Precedex Dexmedetomidine infusion
Priorix Measles vaccine; Mumps vaccine; Rubella vaccine injection
Rapifen Alfentanil injection
Rilutek Riluzole tablet
Rivotril Clonazepam injection
oral solution
Salair Salbutamol aerosol inhaler
Serenace Haloperidol tablet
injection
Taxotere Docetaxel infusion
Tramal Tramadol capsule
injection
oral solution
tablet
Zeffix Lamivudine oral solution
Zeffix Lamivudine tablet
Zepatier Elbasvir; Grazoprevir tablet
 

Additions to the Medsafe Website from 1- 9 May 2017

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Bromocriptine bromocriptine tablet
Bimatoprost Actavis bimatoprost eye drops solution
Cotellic cobimetinib tablet
Updated
Tradename Active ingredient(s) Dose form
Actilyse alteplase injection
Addaven chromium trichloride; copper chloride; ferric chloride; manganese chloride; potassium iodide; sodium fluoride; sodium molybdate; sodium selenite; zinc chloride infusion
Antabuse disulfiram tablet
Arrow - Amitriptyline amitriptyline tablet
Arrow - Bendrofluazide bendrofluazide tablet
Arrow - Brimonidine brimonidine eye drops solution
Arrow - Citalopram citalopram tablet
Arrow - Diazepam diazepam tablet
Arrow - Dortim dorzolamide; timolol eye drops solution
Arrow - Etidronate etidronate tablet
Arrow - Lamotrigine lamotrigine tablet
Arrow - Lisinopril lisinopril tablet
Arrow - Losartan Potassium & Hydrochlorothiazide losartan potassium & hydrochlorothiazide tablet
Arrow - Meloxicam 7.5 meloxicam tablet
Arrow - Morphine LA morphine tablet
Arrow - Ornidazole ornidazole tablet
Arrow - Quinapril quinapril tablet
Arrow - Sertraline sertraline tablet
Arrow - Sumatriptan sumatriptan tablet
Arrow - Timolol timolol eye drops solution
Arrow - Tolterodine tolterodine tablet
Arrow - Tramadol tramadol capsule
Arrow - Venlafaxine XR venlafaxine tablet
Avomine promethazine tablet
Beclazone CFC-Free Inhaler beclometasone inhaler
Elonva corifollitropin alfa injection
Exjade deferasirox tablet
Flucasten One fluconazole capsule
Flucazole fluconazole capsule
Hydroxocobalamin ABM hydroxocobalamin injection
Janumet metformin; sitagliptin tablet
Januvia sitagliptin tablet
Keytruda pembrolizumab infusion
Lioresal baclofen intrathecal solution
Nimotop nimodipine tablet
infusion
Ondanaccord ondansetron injection
Oxytrol oxybutynin patch
Profal finasteride tablet
Revlimid lenalidomide capsule
Risperidone risperidone tablet
Salamol CFC-Free Inhaler salbutamol inhaler
Silagra sildenafil tablet
Stamaril yellow fever vaccine injection
Stelara ustekinumab injection
Stesolid Rectal Tubes Enema diazepam enema
Telfast fexofenadine tablet
oral liquid
suspension
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Cotellic cobimetinib tablet
Updated
Tradename Active ingredient(s) Dose form
Actilyse alteplase injection
Adalat Oros nifedipine tablet
Addaven chromium trichloride; copper chloride; ferric chloride; manganese chloride; potassium iodide; sodium fluoride; sodium molybdate; sodium selenite; zinc chloride infusion
Antabuse disulfiram tablet
Arrow - Amitriptyline amitriptyline tablet
Arrow - Bendrofluazide bendrofluazide tablet
Arrow - Brimonidine brimonidine eye drops solution
Arrow - Citalopram citalopram tablet
Arrow - Clopid clopidogrel tablet
Arrow - Diazepam diazepam tablet
Arrow - Dortim dorzolamide; timolol eye drops solution
Arrow - Etidronate etidronate tablet
Arrow - Gabapentin gabapentin capsule
Arrow - Venlafaxine XR venlafaxine tablet
Betagan levobunolol eye drops solution
Bicalaccord bicalutamide tablet
Carbaccord carboplatin infusion
Celecoxib Pfizer celecoxib tablet
Cernevit ascorbic acid; biotin; cocarboxylase; colecalciferol; cyanocobalamin; dexpanthenol; dl-Alpha tocopherol; folic acid; nicotinamide; pyridoxine; retinol; riboflavin injection
Elonva corifollitropin alfa injection
EpiPen adrenaline injection
EpiPen Junior adrenaline injection
Exjade deferasirox tablet
Flucasten One fluconazole capsule
Flucazole fluconazole capsule
Hydroxocobalamin ABM hydroxocobalamin injection
Ibuprofen ibuprofen tablet
Irinotecan Actavis irinotecan injection
Isoptin verapamil injection
Janumet metformin; sitagliptin tablet
Januvia sitagliptin tablet
Kenacomb gramicidin; neomycin; nystatin; triamcinolone ear drops
Keytruda pembrolizumab infusion
Klacid clarithromycin tablet
oral suspension
injection
Letraccord letrozole tablet
Lioresal baclofen intrathecal solution
Minims Cyclopentolate hydrochloride cyclopentolate eye drops solution
Nauzene cyclizine tablet
Nimotop nimodipine tablet
infusion
Oxaliccord oxaliplatin infusion
Oxaliplatin Actavis oxaliplatin infusion
Oxytrol oxybutynin patch
Pantoprazole Actavis pantoprazole tablet
Phenobarbitone (PSM) phenobarbital tablet
Prevenar 13 pneumococcal vaccine injection
Profal finasteride tablet
Respigen salbutamol aerosol inhaler
Revlimid lenalidomide capsule
Risperidone risperidone tablet
Salamol CFC-Free Inhaler salbutamol inhaler
Seroquel quetiapine tablet
Silagra sildenafil tablet
Soluvit N ascorbic acid; biotin; cyanocobalamin; folic acid; nicotinamide; pantothenic acid; pyridoxine; riboflavin; thiamine injection
Stamaril yellow fever vaccine injection
Stesolid Rectal Tubes Enema diazepam enema
Tecfidera dimethyl fumarate capsule
Telfast fexofenadine tablet
oral liquid
suspension
Terazosin Terazosin tablet
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