About Medsafe

Revised: 2 August 2018

What's New

Additions to the Medsafe Website from 23-31 July 2018


COMMITTEES

Medicines Classification Committee
Minutes of the 60th meeting of the Medicines Classification Committee - Secretary's Note has been added to item 6.3 on Influenza vaccine

Proposed Agenda for the 56th meeting of the Medicines Classification Committee on Natural Health Products – Secretary’s Note has been added

Dates and Deadlines has been updated

SAFETY INFORMATION
Early Warning System – Alert Communication
Consumer Level Recall - Melatonin 3mg tablets

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Bexsero Neisseria meningitidis vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Glucobay acarbose tablet
ReGen finasteride tablet
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Zimybe ezetimibe; simvastatin tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Bexsero Neisseria meningitidis vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Ascor L 500 ascorbic acid injection
Colifoam hydrocortisone enema
Crestor rosuvastatin tablet
DermAid hydrocortisone topical cream
DermAid Soft hydrocortisone topical cream
DP Lotion-HC hydrocortisone topical cream
Holoxan ifosfamide injection
Mestinon pyridostigmine tablet
Oxycodone (Boucher & Muir) oxycodone tablet
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Zimybe ezetimibe; simvastatin tablet


Additions to the Medsafe Website from 16-20 July 2018


Safety
Dear Healthcare Professional Letter
Dissolution profile of Dilantin® 30 mg and 100 mg capsules (New Formulation)

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Linezolid Kabi linezolid infusion
Mylan Midazolam midazolam injection
Updated
Tradename Active ingredient(s) Dose form
Acular ketorolac eye drops
Alcaine proxymetacaine eye drops
Androderm testosterone transdermal patch
Cubicin daptomycin infusion
DP Lotion-HC hydrocortisone lotion
Hybloc labetalol tablet
Keytruda pembrolizumab infusion
Linezolid Kabi linezolid infusion
Livial tibolone tablet
Lucentis ranibizumab injection
Mestinon pyridostigmine tablet
Metamide metoclopramide tablet
Pacific Buspirone buspirone tablet
Tecfidera dimethyl fumarate capsule
Verpamil verapamil tablet
Zeffix lamivudine tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
3TC lamivudine tablet
Linezolid Kabi linezolid infusion
Mylan Midazolam midazolam injection
Updated
Tradename Active ingredient(s) Dose form
Alcaine proxymetacaine eye drops
Androderm testosterone transdermal patch
Beconase Allergy & Hayfever 12 Hour beclometasone nasal spray suspension
Cubicin daptomycin infusion
Dysport botulinum toxin type a injection
Florinef fludrocortisone tablet
Hybloc labetalol tablet
Ibuprofen (Ethics) ibuprofen oral suspension
Keppra levetiracetam tablet
Keytruda pembrolizumab infusion
Lucentis ranibizumab injection
Mestinon pyridostigmine tablet
Metamide metoclopramide tablet
Movapo apomorphine injection
Pacific Buspirone buspirone tablet
Tambocor flecainide injection
Tecfidera dimethyl fumarate capsule
Verpamil verapamil tablet
Xalkori crizotinib capsule


Additions to the Medsafe Website from 9-13 July 2018

Other
Vacancies
Team Leader, Medicines Assessment | Wellington
Assistant Advisor - Product Regulation, Medsafe | Wellington 

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Breo Ellipta fluticasone; vilanterol powder for inhalation
Gliolan aminolevulinic acid oral solution
Levlen ED ethinylestradiol; levonorgestrel tablet
Tagrisso osimertinib tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Binarex bicalutamide tablet
Breo Ellipta fluticasone; vilanterol powder for inhalation
Humira adalimumab injection
Minims Atropine Sulphate 1% atropine eye drops
Zyozyme alglucosidase alfa infusion
Reyataz atazanavir capsule
Tagrisso osimertinib tablet


Additions to the Medsafe Website from 2-6 July 2018


Safety
Dear Healthcare Professional Letter
Provisional Consent of Neulactil periciazine 2.5mg and 10mg tablets (Hong Kong stock) to cover temporary stock shortage (PDF 78 KB, 2 pages)
 
Surgical Regulatory Action on surgical mesh products
Medsafe Advice to Clinicians has been updated

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Acarizax dermatophagoides pteronyssinus allergen extract; dermatophagoides farinae allergen extract tablet
Apo-Nadolol nadolol tablet
Domperidone domperidone tablet
Maviret glecaprevir; pibrentasvir tablet
Solifenacin Mylan solifenacin tablet
Updated
Tradename Active ingredient(s) Dose form
Alphamox amoxicillin suspension
Anten doxepin capsule
Belkyra deoxycholic acid injection
Buscopan and Buscopan Forte hyoscine injection
tablet
Calcium Resonium calcium polystyrene sulfonate powder for oral solution
Celazadine azacitidine injection
Codeine Phosphate (PSM) codeine phosphate tablet
Dermol clobetasol scalp lotion
Dermol clobetasol cream
ointment
Duride SR isosorbide mononitrate tablet
Ezetimibe Sandoz ezetimibe tablet
Genox tamoxifen tablet
Keytruda pembrolizumab infusion
Motilium domperidone tablet
Norvir ritonavir tablet
Resonium-A sodium polystyrene sulfonate powder for oral solution
Saizen, Saizen 3 and Saizen 8 Click Easy somatropin injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Acarizax dermatophagoides pteronyssinus allergen extract; dermatophagoides farinae allergen extract tablet
Baclofen (Medsurge) baclofen injection
Domperidone domperidone tablet
Medicianz Mupirocin econazole ointment
Pevaryl econazole foaming solution
Solifenacin Mylan solifenacin tablet
Updated
Tradename Active ingredient(s) Dose form
Alphamox amoxicillin suspension
Anten doxepin capsule
Apo-Amlodipine amlodipine tablet
Apomine apomorphine infusion
Buscopan and Buscopan Forte hyoscine injection
tablet
Calcium Resonium calcium polystyrene sulfonate powder for oral solution
Celazadine azacitidine injection
Codeine Phosphate (PSM) codeine phosphate tablet
Dermol clobetasol cream
ointment
scalp lotion
Duride SR isosorbide mononitrate tablet
Elonva corifollitropin alfa injection
Eloxatin oxaliplatin infusion
Estrofem estradiol tablet
Ezetimibe Sandoz ezetimibe tablet
Feiba factor viii inhibitor bypassing fraction injection
Fibrovein sodium tetradecyl sulfate injection
Genox tamoxifen tablet
Glucobay acarbose tablet
Indoco Metformin metformin tablet
Intragam P immunoglobulin g infusion
Jespect japanese encephalitis vaccine injection
Kenacomb gramicidin; neomycin; nystatin; triamcinolone ear drops
Keytruda pembrolizumab infusion
Kliogest estradiol; norethisterone tablet
Kliovance estradiol; norethisterone tablet
Mometasone (Multichem) mometasone cream
ointment
Motilium domperidone tablet
Myocrisin aurothiomalate injection
Norvir ritonavir tablet
Ovidrel chorionic gonadotrophin injection (pre-filled pen)
Pulmicort Turbuhaler budesonide powder for inhalation
Resonium-A sodium polystyrene sulfonate powder for oral solution
Saizen somatropin injection
Saizen 3 and Saizen 8 Click Easy somatropin injection
Trisequens estradiol; norethisterone tablet
Xeomin botulinum toxin type a injection
Zytiga abiraterone tablet