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About Medsafe

Revised: 19 January 2016

What's New


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
   
        

Additions to the Medsafe Website from 12 November-2 December 2016
 

COMMITTEES
Medicines Adverse Reactions Committee meeting
Agenda for the 168th Medicines Adverse Reactions Committee meeting - 1 December 2016

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Lynparza olaparib capsule
Genvoya cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide tablet
Levetiracetam (Pharmacare) levetiracetam tablet
Escitalopram (Pharmacare) escitalopram tablet
Epclusa sofosbuvir; velpatasvir tablet
Arnuity Ellipta fluticasone furoate powder for inhalation
Apo-Metoprolol metoprolol tartrate tablet
Alphagan P brimonidine tartrate eye drops
Updated
Tradename Active ingredient(s) Dose form
Picato 0.015% ingenol mebutate gel
Picato 0.05% ingenol mebutate gel
Burinex bumetanide tablet
Lumigan PF bimatoprost eye drops
Oncotice BCG vaccine injection
Duac once daily clindamycin; benzoyl peroxide topical gel
Tykerb lapatinib tablet
Sativex cannabidiol; tetrahydrocannabinol
Tivicay dolutegravir tablet
Stelazine trifluoperazine hydrochloride tablet
Tysabri natalizumab infusion
RotaTeq rotavirus vaccine suspension
Emla lignocaine, prilocaine dermal patch
topical cream
Diurin 40 furosemide tablet


DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Lynparza olaparib capsule
Levetiracetam (Pharmacare) levetiracetam tablet
Escitalopram (Pharmacare) escitalopram tablet
Epclusa sofosbuvir; velpatasvir tablet
Cosentyx secukinumab injection
Apo-Metoprolol metoprolol tartrate tablet
Lantus and Lantus SoloStar insulin glargine injection
Arnuity Ellipta fluticasone furoate powder for inhalation
Updated
Tradename Active ingredient(s) Dose form
RotaTeq rotavirus vaccine oral suspension
Burinex bumetanide tablet
Oxycodone Orion oxycodone hydrochloride injection
Firazyr icatibant acetate injection
Oncotice BCG vaccine injection
Prevenar 13 pneumococcal polysaccharide conjugate vaccine injection
Duac once daily clindamycin; benzoyl peroxide gel
Curosurf poractant alfa injection
Tykerb lapatinib tablet
Intron A Redipen interferon alfa-2b injection
Sativex cannabidiol; tetrahydrocannabinol
Tivicay dolutegravir tablet
Vimpat lacosamide injection
Imbruvica ibrutinib capsule
Prolia denosumab injection
Stelazine trifluoperazine hydrochloride tablet
Depo-Provera medroxyprogesterone acetate injection
Genvoya elvitegravir; cobicistat; emtricitabine; tenofovir alafenamide tablet
Tysabri natalizumab infusion
Simponi golimumab injection
Lantus and Lantus SoloStar insulin glargine injection
Stelazine trifluoperazine hydrochloride tablet
Curam and Curam Duo amoxicillin, clavulanic acid oral suspension
Citanest Plain prilocaine hydrochloride injection
Diprivan propofol injection
Marcain Plain
Marcain with Adrenaline
bupivacaine hydrochloride with and without adrenaline injection
Marcain Spinal bupivacaine hydrochloride injection
Naropin ropivacaine hydrochloride injection
Naropin with Fentanyl ropivacaine hydrochloride, fentanyl citrate infusion
Xylocaine Jelly lignocaine topical gel
Xylocaine
Xylocaine with Adrenaline
lignocaine with and without adrenaline injection
Xylocaine Pump Spray lignocaine oral spray pump
Xylocaine Viscous lignocaine oral solution
Emla lignocaine, prilocaine dermal patch
topical cream
Durin 40 furosemide tablet
Penthrox Volatile methoxyflurane liquid for inhalation
Gazyva obinutuzumab injection
Sunvepra asunaprevir capsule
Daklinza daclatasvir tablet


Additions to the Medsafe Website from 31 October – 11 November 2016


CONSULTATIONS
Outcome of consultation on proposed changes to the data sheet format

MEDICINES
Influenza Vaccine Composition

Forms and Templates
Changed Medicine Notification Form A (effective from November 2016) (Microsoft Word 151KB)
Changed Medicine Notification Form B
(effective from November 2016) (Microsoft Word 124KB)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Ganfort bimatoprost, timolol (as maleate) eye drops
Otezla apremilast tablet
Prolia denosumab(rch) injection
Solifenacin solifenacin succinate tablet
Updated
Tradename Active ingredient(s) Dose form
Adefin XL nifedipine tablet
Flagyl metronidazole benzoate suppository
oral suspension
Ganfort PF bimatoprost, timolol (as maleate) eye drops
Humira adalimumab (rch) injection solution
Humira Pen adalimumab (rch) injection solution
Keytruda pembrolizumab infusion
Leunase asparaginase injection
Plavix clopidogrel tablet
Revolade eltrombopag olamine tablet
Stribild tenofovir disoproxil fumarate, emtricitabine, elvitegravir, cobicistat tablet
Votrient pazopanib hydrochloride tablet
Zimybe ezetimibe, simvastatin tablet

DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Brinov capecitabine tablet
Otezla apremilast tablet
Solifenacin solifenacin succinate tablet
Updated
Tradename Active ingredient(s) Dose form
Abilify aripiprazole tablet
Adefin XL nifedipine tablet
Avastin bevacizumab injection
Capecitabine Winthrop capecitabine tablet
Flagyl and Flagyl S metronidazole benzoate suppository
oral suspension
Glivec imatinib mesilate tablet
Humira adalimumab (rch) injection
Keytruda pembrolizumab infusion
Leunase asparaginase injection
Picato ingenol mebutate gel
PipTaz BNM piperacillin sodium + tazobactam sodium injection
Revolade eltrombopag olamine tablet
Stribild tenofovir disoproxil fumarate, emtricitabine, elvitegravir, cobicistat tablet
Viekira PAK paritaprevir, ritonavir, ombitasvir, dasabuvir combination therapy pack
Viekira PAK-RBV paritaprevir, ritonavir, ombitasvir, ribavirin, dasabuvir combination therapy pack
Votrient pazopanib hydrochloride tablet
Zimybe ezetimibe, simvastatin tablet
 
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