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About Medsafe

Revised: 28 September 2017

What's New

Additions to the Medsafe Website from 4-13 October 2017


ABOUT MEDSAFE
Vacancies
Advisor/Senior Advisor Pharmacovigilance

COMMITTEES
Medicines Classification Committee
Comments on agenda for the 59th Medicines Classification Committee meeting

MEDICINES
Regulatory Timelines
Medsafe’s performance against evaluation timeframes 2016

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Actair dermatophagoides farinae allergen extract; dermatophagoides pteronyssinus allergen extract tablet
Updated
Tradename Active ingredient(s) Dose form
Catapres clonidine tablet
Fluorouracil Ebewe fluorouracil injection
Gastro-Soothe hyoscine butylbromide tablet
Invokana canagliflozin tablet
Keytruda pembrolizumab infusion
Lithicarb FC lithium tablet
Luvox fluvoxamine tablet
Mydriacyl tropicamide eye drops
Naxen naproxen tablet
Nucala mepolizumab injection
Sofradex dexamethasone; framycetin; gramicidin ear/eye drops
Sporanox itraconazole capsule
Sporanox itraconazole oral solution
Stivarga regorafenib tablet
Synflorix pneumococcal vaccine injection
Tacrolimus Sandoz tacrolimus capsule
Travatan travoprost eye drops
Voltaren diclofenac suppository
Voltaren diclofenac injecton
Voltaren, Voltaren D, Voltaren SR diclofenac tablet
dispersible tablet
sustained release tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Abstral fentanyl tablet
Actair dermatophagoides farinae allergen extract; dermatophagoides pteronyssinus allergen extract tablet
Nausafix prochlorperazine tablet
Updated
Tradename Active ingredient(s) Dose form
Augmentin amoxicillin; clavulanic acid injection
DBL Atracurium Besylate atracurium besylate injection
DBL Bleomycin Sulphate bleomycin sulphate injection
DBL Gentamicin BP gentamicin injection
DBL Morphine Tartrate morphine tartrate injection
DBL Octreotide octreotide injection
DBL Oxaliplatin oxaliplatin injection
DBL Promethazine Hydrochloride promethazine hydrochloride injection
Fluorouracil Ebewe fluorouracil injection
Frumil amiloride; furosemide tablet
Gastro-Soothe hyoscine butylbromide tablet
Ibrance palbociclib capsule
Ibuprofen Generic Health (Neo Health NZ) ibuprofen capsule
Invokana canagliflozin tablet
Keytruda pembrolizumab infusion
Lithicarb FC lithium tablet
Luvox fluvoxamine tablet
Methadone Molteni methadone oral solution
Mydriacyl tropicamide eye drops
Myleran busulfan tablet
Naxen naproxen tablet
Neosynephrine phenylephrine injection
Pamisol pamidronic acid injection
Panadol Cold & Flu Max + Decongestant paracetamol; phenylephrine hydrochloride solution
Profal finasteride tablet
Stivarga regorafenib tablet
Synflorix pneumococcal vaccine injection
Travatan travoprost eye drops
Voltaren diclofenac tablet
Voltaren diclofenac suppository
Voltaren diclofenac injecton
Voltaren D diclofenac dispersible tablet
Voltaren SR diclofenac sustained release tablet
Xalkori crizotinib capsule


Additions to the Medsafe Website from 27 September-4 October 2017


About Medsafe
Notice of Medsafe Office Closure Christmas/New Year 2017/2018
 
Committees
Medicines Adverse Reactions Committee
Minutes of the 171st meeting of the Medicines Adverse Reactions Committee - 14 September 2017
 
Medicines Assessment Advisory Committee
The following pages have been updated
Terms of Reference
Committee Processes
Vacancies
 
Media Releases
Medsafe highlights the dangers of purchasing medicines over the internet
 
Publications
Recent Official Information Act Releases
Request for Records for Hormonal Pregnancy Tests (2) (Adobe PDF 29663 KB, 70 pages)
Request for Records for Hormonal Pregnancy Tests (Adobe PDF 15985 KB, 54 pages)
Request for items 4.1.2 to 4.1.5 of the 162nd Medicines Adverse Reactions Committee meeting (including 2014 Annual Review of Fatalities) (Adobe PDF 2901 KB, 48 pages)
Request for 2016 Annual Review of Fatalities (Adobe PDF 7042 KB, 21 pages)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Hiberix haemophilus influenzae type b vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Cardizem CD diltiazem capsule
CellCept mycophenolic acid capsule
tablet
infusion
suspension
Colifoam hydrocortisone rectal foam
Cubicin daptomycin infusion
D-Penamine penicillamine tablet
Enlafax XR venlafaxine capsule
Nuelin-SR theophylline tablet
Ritalin methylphenidate tablet
modified release tablet
Ritalin LA methylphenidate modified releae capsule
Rulide D roxithromycin tablet
Trileptal oxcarbazepine tablet
Visudyne verteporfin infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Adenosine-Claris (30mg/10ml) adenosine injection
Adenosine-Claris (6mg/2ml) adenosine injection
Dianeal calcium chloride; glucose; lactic acid; magnesium chloride; sodium chloride dialysis solution
Hiberix haemophilus influenzae type b vaccine injection
Updated
Tradename Active ingredient(s) Dose form
0.9% Sodium Chloride (Baxter) sodium chloride infusion
Asthalin salbutamol solution for inhalation
Cisplatin Ebewe cisplatin injection
Colifoam hydrocortisone rectal foam
Cubicin daptomycin infusion
DBL Amikacin amikacin injection
DBL Dobutamine Hydrochloride dobutamine hydrochloride injection
DBL Heparin Sodium BP heparin injection
DBL sodium acetate sodium acetate injection
DBL sodium thiosulfate sodium thiosulfate injection
D-Penamine penicillamine tablet
Enlafax XR venlafaxine capsule
Forthane isoflurane liquid for inhalation
Ibugesic ibuprofen tablet
Loette ethinyloestradiol; levonorgestrel tablet
Metformin Mylan metformin tablet
Monofeme ethinyloestradiol; levonorgestrel tablet
Octreotide MaxRx octreotide injection
Ritalin methylphenidate tablet
modified release tablet
modified releae capsule
Sofradex dexamethasone; framycetin; gramicidin ear/eye drops
Trileptal oxcarbazepine tablet
Visudyne verteporfin infusion


Additions to the Medsafe Website from 18-26 September 2017

Consultations
Outcome
Outcome of consultation on change to warning statements on labels of oral non-steroidal anti-inflammatory drugs (NSAIDs) available without a prescription
 
Medical Devices
WAND
WAND New Sponsor Application Form (Microsoft Word document 94 KB) – the only change is the removal of the fax number for Medsafe from this form
 
Medicines
Schedule of Fees
Discretionary GMP Audit fees have changed
 
Publications
Recent OIA Releases
Request for archival records for Amenorone Forte (Adobe PDF 10,173 KB, 40 pages)
 
Safety Information
Early Warning System – Alert Communication
Consumer Level Recall - Maxiclear Sinus & Pain Relief and Maxiclear Cold & Flu Relief

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Arrow-Tramadol tramadol capsule
Cosudex bicalutamide tablet
Hypnovel midazolam tablet
Hypnovel midazolam injection
Influvac influenza vaccine polyvalent injection
Metformin (Generic Health) metformin tablet
NovoRapid neutral insulin injection
Rapifen alfentanil injection
Rulide D roxithromycin tablet
Synflorix pneumococcal vaccine injection
Tegretol and Tegretol CR carbamazepine tablet
syrup
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Apo-Propranolol propranolol tablet
Benztropine Omega benzatropine injection
DP-Travoprost travoprost eye drops solution
Pemetrexed Juno pemetrexed infusion
Tranexamic Acid (Medsurge) tranexamic acid injection
Updated
Tradename Active ingredient(s) Dose form
Avonex interferon beta injection
Buscopan hyoscine tablet
injection
CellCept mycophenolic acid capsule
powder for infusion
powder for suspension
Enbrel etanercept injection
Epiduo adapalene; benzoyl peroxide gel
Glycoprep macrogols; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate powder
HyperHEB B hepatitis b immunoglobulin injection
Hypnovel midazolam tablet
Hypnovel midazolam injection
Ketalar ketamine injection
Leunase asparaginase injection
Metformin (Generic Health) metformin tablet
Mirvaso brimonidine gel
Multihance gadobenic acid injection
Nurofen Plus codeine; ibuprofen tablet
Omeprazole Actavis omeprazole capsule
Omniscan gadodiamide injection
Ozurdex dexamethasone intraocular implant
Postinor-1 levonorgestrel tablet
Pradaxa dabigatran capsule
Recombivax HB hepatitis b vaccine injection
Tecfidera dimethyl fumarate capsule
Tegretol and Tegretol CR carbamazepine tablet
syrup
Telfast fexofenadine tablet
Terbinafine-DRLA terbinafine tablet
Xanax alprazolam tablet
Xylocaine Viscous lidocaine oral solution
Influvac influenza vaccine polyvalent injection
Midazolam (Pfizer) midazolam injection
Synflorix pneumococcal vaccine injection
Lynparza olaparib capsule
Cosudex bicalutamide tablet
RA-Morph morphine solution
Pipetam piperacillin; tazobactam injection
Rulide D roxithromycin tablet
Arrow-Tramadol tramadol capsule
DBL Morphine Sulfate injection BP morphine sulfate injection
DBL Fentanyl fentanyl injection
Anzatax paclitaxel injection
DBL Tobramycin tobramycin injection
DBL Vinblastine vinblastine injection
DBL Vincristine Sulfate vincristine sulfate injection
DBL Vinorelbine vinorelbine injection

Additions to the Medsafe Website from 11-18 September 2017

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Zydelig Idelalisib tablet
Updated
Tradename Active ingredient(s) Dose form
2% Xylocaine Dental with Adrenaline Adrenaline; Lidocaine injection
Apidra and Apidra Solostar Neutral insulin injection
Entapone Entacapone tablet
Imovane Zopiclone tablet
Intelence Etravirine tablet
Lantus and Lantus SoloStar Neutral insulin injection
Marvelon 28 Desogestrel; ethinylestradiol tablet
Sabril Vigabatrin tablet
Tecentriq Atezolizumab infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Flumazenil-Claris Flumazenil injection
Zydelig Idelalisib tablet
Updated
Tradename Active ingredient(s) Dose form
2% Xylocaine Dental with Adrenaline Adrenaline; Lidocaine injection
4% Articadent Dental with Adrenaline Adrenaline; Articaine injection
Apidra and Apidra Solostar Neutral insulin injection
Cardizem Diltiazem tablet
Cardizem CD Diltiazem capsule
Cefazolin-AFT Cefazolin injection
Cyklokapron Tranexamic acid tablet
injection
DBL Aciclovir Intravenous Aciclovir infusion
DBL Carboplatin Carboplatin injection
DBL Cisplatin Cisplatin injection
DBL Dacarbazine Dacarbazine injection
DBL Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate injection
DBL Ephedrine Sulfate Ephedrine Sulfate injection
Depo-Medrol with Lidocaine Methylprednisolone acetate; lidocaine hydrochloride injection
Entapone Entacapone tablet
Haldol Haloperidol decanoate injection
Leveitracetam-AFT Leveitracetam oral solution
infusion
Levemir Insulin detemir injection
Locacorten-Viaform Clioquinol; Flumetasone ear drops
Locorten-Vioform Clioquinol; Flumetasone ear drops
Medrol Methylprednisolone acetate tablet
Nivestim Filgrastim injection
Oralair (Initiation and Continuation treatment) Initiation (Allergens; Grass pollen extract)
Continuation (Grass pollen extract)
tablet
Panadeine Extra Codeine; Paracetamol tablet
Panafen Plus Codeine; Ibuprofen tablet
Sabril Vigabatrin tablet
Tecentriq Atezolizumab infusion
Tranexamic-AFT Tranexamic acid injection
Xigduo XR Dapagliflozin; Metformin tablet
Zerbaxa Ceftolozane; Tazobactam injection
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