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Revised: 20 February 2016

What's New


Additions to the Medsafe Website from 6-10 February 2017


INFORMATION FOR CONSUMERS

Consumer Information Leaflets
Medicines for Gout (PDF 249 KB, 2 pages)

SAFETY INFORMATION
Early Warning System – Monitoring Communications
Update -   Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme

Adverse Event Reports Relating to Surgical Mesh Implants - December 2016 (PDF 391 KB, 25 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Merieux Inactivated Rabies Vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Afinitor Everolimus tablet
Champix Varenicline tablet
Cozaar Losartan tablet
Drixine Oxymetazoline nasal spray
Glivec Imatinib capsules
Invega Trinza Paliperidone injection
Marvelon 28 Desogestrel; Ethinylestradiol tablet
Mercilon 28 Desogestrel; Ethinylestradiol tablet
Methoblastin Methotrexate tablet
Nozinan levomepromazine maleate tablet
injection
NuvaRing Etonogestrel; ethinylestradiol vaginal ring
DATA SHEETS
New
Tradename active ingredient(s) dose form
Apo-Terazosin Terazosin tablet
Updated
Tradename Active ingredient(s) Dose form
Afinitor Everolimus tablet
Arrow-Losartan Hydrochlorothiazide; Losartan tablet
BeneFIX nonacog alfa (rch) injection
Bicalaccord Bicalutamide tablet
Champix Varenicline tablet
Cozaar Losartan tablet
DBL Glyceryl Trinitrate Glyceryl trinitrate injection
Fentanyl Sandoz Fentanyl patch
Invega Trinza Paliperidone injection
Invokana Canagliflozin tablet
Losartan Actavis Losartan tablet
Marvelon 28 Desogestrel; Ethinylestradiol tablet
Mercilon 28 Desogestrel; Ethinylestradiol tablet
Neulactil Periciazine tablet
Neurontin Gabapentin capsule
tablet
Nozinan Levomepromazine tablet
injection
NuvaRing Etonogestrel; ethinylestradiol vaginal ring
Piportil Pipotiazine injection
Prezista Darunavir tablet
ReoPro Abciximab injection
Zypine ODT Olanzapine wafer
 

Additions to the Medsafe Website from 16 January-3 February 2017


ABOUT MEDSAFE

Vacancies
Advisor / Senior Advisor (Science), Product Regulation Branch, Medsafe

COMMITTEES
Medicines Assessment Advisory Committee
Agenda for the 104th meeting of the Medicines Assessment Advisory Committee - 23 February 2017

Medicines Classification Committee
Secretary's note regarding the minutes of the Medicines Classification Committee - 1 November 2016

INFORMATION FOR CONSUMERS
Consumer Educational Materials
Gardasil 9 Questions and Answers

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Allmercap mercaptopurine oral suspension
Morphine Juno morphine injection
Simbrinza brinzolamide; brimonidine tartrate eye drops
Updated
Tradename Active ingredient(s) Dose form
Aclasta zoledronic acid infusion
Act-Hib haemophilus influenzae type b vaccine injection
Adacel diphtheria vaccine; pertussis vaccine; tetanus vaccine injection
Anoro Ellipta umeclidinium; vilanterol powder for inhalation
Aratac amiodarone tablet
Arnuity Ellipta fluticasone powder for inhalation
Aropax paroxetine tablet
Aubagio teriflunomide tablet
Betnovate betamethasone lotion
Breo Ellipta fluticasone; vilanterol powder for inhalation
Duavive conjugated oestrogens/bazedoxifene tablet
Duodopa carbidopa; levodopa intestinal gel
Elidel pimecrolimus topical cream
Exjade deferasirox tablet
Humira adalimumab injection
Humira Pen adalimumab injection
Ikorel nicorandil tablet
Incruse Ellipta umeclidinium powder for inhalation
Itrazole itraconazole capsule
Kaletra lopinavir; ritonavir oral solution
tablet
Lariam mefloquine tablet
Lorstat atorvastatin tablet
Monofeme ethinylestradiol; levonorgestrel tablet
Neupogen filgrastim injection
Norvir ritonavir oral solution
tablet
Rapamune sirolimus tablet
Rapamune sirolimus oral solution
Rheumon etofenamate topical gel
Saizen 3
Saizen 8
somatropin injection
Sensipar cinacalcet tablet
Stelara ustekinumab injection
Telfast fexofenadine tablet
Tilcotil tenoxicam tablet
Ursosan ursodeoxycholic acid capsule
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir tablet
Votrient pazopanib tablet
Xyntha moroctocog alfa injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Montelukast montelukast tablet
Apo-Sumatriptan sumatriptan tablet
Morphine Juno morphine injection
Simbrinza brinzolamide; brimonidine tartrate eye drops
Updated
Tradename Active ingredient(s) Dose form
Act-Hib haemophilus influenzae type b vaccine injection
Adacel diphtheria vaccine; pertussis vaccine; tetanus vaccine injection
Allmercap mercaptopurine oral suspension
Anoro Ellipta umeclidinium; vilanterol powder for inhalation
Aratac amiodarone tablet
Arnuity Ellipta fluticasone powder for inhalation
Aropax paroxetine tablet
Aubagio teriflunomide tablet
Betaferon interferon beta injection
Betnovate betamethasone lotion
Breo Ellipta fluticasone; vilanterol powder for inhalation
Cefalexin Sandoz cefalexin capsule
suspension
Celecoxib Pfizer celecoxib tablet
Duodopa carbidopa; levodopa intestinal gel
Duolin ipratropium; salbutamol aerosol inhaler
Enbrel etanercept injection
ERA Filmtab erythromycin tablet
Erythrocin- IV erythromycin injection
Exjade deferasirox tablet
Ginet cyproterone; ethinylestradiol tablet
Humira
Humira Pen
adalimumab injection
Ikorel nicorandil tablet
Imuran azathioprine tablet
Incruse Ellipta umeclidinium power for inhalation
Kaletra lopinavir; ritonavir oral solution
tablet
Kemadrin procyclidine tablet
Lariam mefloquine tablet
Lidocaine-Claris lidocaine injection
Lisinopril lisinopril tablet
Lorstat atorvastatin tablet
Metformin metformin tablet
Nausicalm cyclizine tablet
Neupogen filgrastim injection
Norvir ritonavir oral solution
tablet
Ospamox amoxicillin capsule
powder for oral suspension
granules for oral suspension
Paclitaxel Ebewe paclitaxel injection
Phenoxymethylpenicillin-AFT phenoxymethylpenicillin oral solution
Plavix clopidogrel tablet
RA-Morph morphine oral solution
Rapamune sirolimus oral solution
tablet
Rheumon etofenamate topical gel
Saizen 3
Saizen 8
somatropin injection
Sensipar cinacalcet tablet
Seretide fluticasone; salmeterol aerosol inhaler
Seretide Accuhaler fluticasone; salmeterol powder for inhalation
Sevredol morphine tablet
Telfast fexofenadine oral liquid
Tilcotil tenoxicam tablet
Votrient pazopanib tablet
Xyntha moroctocog alfa injection



Additions to the Medsafe Website from 9-13 January 2017


ABOUT MEDSAFE
Vacancies
Manager, Clinical Risk Management Branch, Medsafe
 
COMMITTEES
Medicines Classification Committee
Medicines Classification Committee - Minutes for the 57th meeting  - 1 November 2016
 
PUBLICATIONS
Medicines Classification - Oral Contraception Recommendation made
 
SAFETY
Dear Healthcare Professional Letter
Erivedge (PDF 110 KB, 2 pages) - Extension of Pregnancy Prevention Duration for Women of Childbearing Potential and Interval before Blood Donation and Lactation

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Aclasta zoledronic acid infusion
Atripla tenofovir disoproxil fumarate; emtricitabine; efavirenz tablet
Canesten Clotrimazole Thrush Treatment Once clotrimazole pessary and cream, combination
Colifoam hydrocortisone rectal foam
Concerta methylphenidate extended release tablet
Metformin Mylan metformin tablet
Otezla apremilast tablet
Pomalyst pomalidomide capsule
Revolade eltrombopag tablet
Viread adefovir dipivoxil; tenofovir disoproxil fumarate tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Aclasta zoledronic acid infusion
Apo-Allopurinol allopurinol tablet
Atripla tenofovir disoproxil fumarate; emtricitabine; efavirenz tablet
Colifoam hydrocortisone rectal foam
Elidel pimecrolimus topical cream
Foscavir foscarnet infusion
Itrazole itraconazole capsule
Metformin Mylan metformin tablet
Methoblastin methotrexate tablet
NovoSeven RT factor vii injection
Pomalyst pomalidomide capsules
Postinor-1 levonorgestrel tablet
Revolade eltrombopag tablet
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir tablet
Viread adefovir dipivoxil; tenofovir disoproxil fumarate tablet


Additions to the Medsafe Website from 5 December 2016 - 6 January 2017


COMMITTEES

Medicines Adverse Reactions Committee
Medicines Adverse Reactions Committee - Minutes for the 168th Meeting - 1 December 2016
 
Medicines Classification Committee
Medicines Classification Committee - Recent Gazette Notices
Medicines Classification Committee - Dates and Deadlines
 
MEDICAL DEVICES
Update: Implementation of Government Response to Report of the Health Committee on Petition 2011/102
 
Reporting Adverse Events Associated With Medical Devices
 
PUBLICATIONS
Information for Women with Breast Implants
 
Prescriber Update
Vol. 37 No. 4 - December 2016
Answers to the Prescriber Update Quiz - December 2016
 
SAFETY INFORMATION
Update to Monitoring Communication
EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results
 
Alert Communication
Consumer Level Recall – Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling used for patient hoists 

CONSUMER MEDICINE INFORMATION
New    
Tradename Active ingredient(s) Dose form
Copegus ribavirin tablet
Finasteride (Pharmacare) 1mg finasteride tablet
Finasteride (Pharmacare) 5mg finasteride tablet
Noradrenaline BNM noradrenaline injection
One Alpha alfacalcidol capsule oral drops
Rheumon etofenamate topical gel
Sativex cannabidiol; tetrahydrocannabinol oral spray
Zepatier elbasvir; grazoprevir tablet
Updated    
Tradename Active ingredient(s) Dose form
Beclazone beclometasone cfc-free inhaler inhaler
Benzac AC benzoyl peroxide topical gel
Brilinta ticagrelor tablet
Cardizem and Cardizem CD diltiazem capsule tablet
Clobex clobetasol shampoo
Depo-Provera medroxyprogesterone injection
Enbrel etanercept injection
Epiduo adapalene; benzoyl peroxide gel
Epilim valproic acid injection
Epilim and Epilim EC valproic acid tablet liquid solution syrup
Erivedge vismodegib capsule
Estradot estradiol transdermal patch
Eviplera emtricitabine; rilpivirine; tenofovir tablet
FluQuadri and FluQuadri Junior influenza vaccine polyvalent injection
Imbruvica ibrutinib capsule
Influvac influenza vaccine polyvalent injection
Klacid clarithromycin tablet oral suspension injection modified release tablet
Konakion MM and Konakion MM Paediatric phytomenadione injection
Marvelon 28 desogestrel; ethinylestradiol tablet
Mercilon 28 desogestrel; ethinylestradiol tablet
Metvix methyl aminolevulinate cream
MMR II Vaccine measles vaccine; mumps vaccine; rubella vaccine injection
NuvaRing ethinylestradiol; etonogestrel vaginal ring
Polaramine dexchlorpheniramine tablet
Postinor-1 levonorgestrel tablet
Provera and Provera HD medroxyprogesterone tablet
Revlimid lenalidomide capsule
Rifadin rifampicin capsule
Sutent sunitinib capsule
Thalomid thalidomide capsule
Tramadol Hydrochloride tramadol capsule
Vaxigrip influenza vaccine polyvalent injection
Vttack voriconazole tablet
 
DATA SHEETS
New    
Tradename Active ingredient(s) Dose form
Allmercap mercaptopurine oral suspension
Apo-Paroxetine paroxetine tablet
Finasteride (Pharmacare) 1mg finasteride tablet
Finasteride (Pharmacare) 5mg finasteride tablet
Noradrenaline BNM noradrenaline injection
One Alpha alfacalcidol capsule oral drops
Rheumon etofenamate topical gel
Zepatier elbasvir; grazoprevir tablet
Updated    
Tradename Active ingredient(s) Dose form
Abilify aripiprazole tablet
Angiomax bivalirudin injection
Angiomax bivalirudin injection
Beclazone beclometasone cfc-free inhaler inhaler
Brilinta ticagrelor tablet
Cafergot caffeine; ergotamine tablet
Cardizem diltiazem tablet
Cardizem CD diltiazem capsule
Concerta methylphenidate tablet
Creon pancreatin capsule
Depo-Provera medroxyprogesterone injection
Depo-Testosterone testosterone injection
Dexamethasone dexamethasone injection
Effient prasugrel tablet
Enbrel etanercept injection
Epilim and Epilim EC valproic acid tablet injection oral solution syrup
EpiPen and EpiPen Junior adrenaline injection
Erivedge vismodegib capsule
Esbriet pirfenidone capsule
Estradot estradiol transdermal patch
Eviplera emtricitabine; rilpivirine; tenofovir tablet
FluQuadri and FluQuadri Junior influenza vaccine polyvalent injection
Gonal-F follitropin injection
Imbruvica ibrutinib capsule
Influvac influenza vaccine polyvalent injection
Isoptin verapamil injection
Klacid clarithromycin tablet oral suspension injection modified release tablet
Konakion MM and Konakion MM Paediatric phytomenadione injection
Marvelon 28 desogestrel; ethinylestradiol tablet
MMR II Vaccine measles vaccine; mumps vaccine; rubella vaccine injection
Nauzene cyclizine tablet
Noxafil posaconazole tablet
NuvaRing ethinylestradiol; etonogestrel vaginal ring
Otezla apremilast tablet
Pentacarinat pentamidine injection
Polaramine dexchlorpheniramine tablet
Postinor-1 levonorgestrel tablet
Provera and Provera HD medroxyprogesterone acetate tablet
Reminyl galantamine capsule
Risperdal and Risperdal Quicklet risperidone tablet  
Rytmonorm propafenone tablet
Simponi golimumab injection
Strattera atomoxetine capsule
Suboxone buprenorphine; naloxone tablet
Sutent sunitinib capsule
Temgesic buprenorphine injection
Thalomid thalidomide capsule
Tramadol Hydrochloride tramadol capsule
Vaxigrip influenza vaccine polyvalent injection
Vttack voriconazole tablet
Zerbaxa ceftolozane; tazobactam injection
Zyprexa olanzapine injection
Zyprexa and Zyprexa Zydis olanzapine tablet wafer
Zyprexa Relprevv olanzapine injection
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