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About Medsafe

Revised: 28 November 2017

What's New

Additions to the Medsafe Website from 15-27 November 2017


COMMITTEES

Medicines Adverse Reactions Committee
Agenda for the 172nd Medicines Adverse Reactions Committee meeting - 7 December 2017

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Celestone Chronodose betamethasone injection
Ibuprofen (Relieve) ibuprofen tablet
Updated
Tradename Active ingredient(s) Dose form
Amoxil amoxicillin injection
Arcoxia etoricoxib tablet
Cymevene ganciclovir infusion
Glivec imatinib tablet
capsule
Sandostatin LAR octreotide injection
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Valcyte valganciclovir tablet
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir combination product
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir combination product
Votrient pazopanib tablet
Xenical orlistat capsule
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Binarex bicalutamide tablet
Fardoben Gargle benzydamine; chlorhexidine gargle
Fardoben Throat Spray benzydamine; chlorhexidine spray
Ibuprofen (Relieve) ibuprofen tablet
Updated
Tradename Active ingredient(s) Dose form
Advate octocog alfa injection
Amoxil amoxicillin injection
Arcoxia etoricoxib tablet
Breo Ellipta fluticasone; vilanterol powder for inhalation
Celestone Chronodose betamethasone injection
Dilantin phenytoin sodium capsule
tablet
oral supension
Enbrel etanercept injection
Glivec imatinib tablet
capsule
GlucaGen HypoKit glucagon injection
Pamisol pamidronic acid injection
Sandostatin LAR octreotide injection
Sterile Dopamine Concentrate BP (Max Health Ltd) dopamine injection
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Valcyte valganciclovir tablet
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir combination product
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ribavirin; ritonavir combination product
Votrient pazopanib tablet
Xalkori crizotinib capsule
Xenical orlistat capsule
 

Additions to the Medsafe Website from 6-14 November 2017


CONSULTATIONS

MEDICINES
Forms and templates
The following 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.

  1. Product Status Change Request Form (effective from November 2017) (Microsoft Word 45KB)
  2. Changes to the Collection and Manufacturing Standards for New Zealand Blood Service (effective from November 2017) (Microsoft Word document 41KB)
  3. Application to accompany a request for a Certificate of Pharmaceutical Product (effective from November 2017) (Microsoft Word document 44KB)
  4. Guide to Completing a New Medicine Application - Prescription Medicine (effective from November 2017) (Microsoft Word document 150KB)
  5. New Medicine Application - Prescription Medicine Form (effective from November 2017) (Microsoft Word non-macro enabled form 196KB)
  6. New Medicine Application - Prescription Medicine Declarations and Commitments (effective from November 2017) (Microsoft Word 84KB)
CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Apidra Neutral insulin injection
Ciproxin HC Ciprofloxacin; hydrocortisone Ear drops
Dapa-tabs Indapamide tablet
Diprosone Betamethasone Cream
ointment
Diprosone OV Betamethasone Cream
ointment
Emend Aprepitant capsule
EpiPen Adrenaline injection
EpiPen Junior Adrenaline injection
Imovane Zopiclone tablet
Influvac Influenza vaccine polyvalent injection
Kuvan Sapropterin dihydrochloride tablet
Lasix and Lasix High Dose Furosemide Infusion
Oral solution
Lynparza Olaparib capsule
Nevanac Nepafenac Eye drops
Onbrez Breezehaler Indacaterol capsule
Patanol Olopatadine hydrochloride Eye drops
Simvastatin Mylan simvastatin tablet
Terod Dutasteride capsule
Venclexta Venetoclax tablet
Xarelto Rivaroxaban Tablet
DATA SHEETS
Updated
Tradename Active ingredient(s) Dose form
Buccaline Haemophilus influenzae type b; Staphylococcus aureus; Streptococcus agalactiae; Streptococcus pneumoniae tablet
Ceftriaxone Ceftriaxone Injection
infusion
Cefuroxime Actavis Cefuroxime Injection
Ciproxin HC Ciprofloxacin; hydrocortisone Ear drops
Dapa-tabs Indapamide tablet
DBL Pethidine Hydrochloride Pethidine Hydrochloride Injection
DBL Rocuronium Bromide Rocuronium Bromide Injection
DBL Sodium Nitroprusside Sodium Nitroprusside Injection
Diprosone Betamethasone Cream
ointment
Diprosone OV Betamethasone Cream
ointment
Dotarem Gadoteric acid Injection
Elocon Mometasone
Elocon Alcohol Free Mometasone
Emend Aprepitant capsule
EpiPen Adrenaline injection
EpiPen Junior Adrenaline injection
Granisetron Granisetron injection
Haldol Haloperidol
Imiquimod Imiquimod cream
Influvac Influenza vaccine polyvalent injection
Kenacomb Gramicidin; Neomycin; Nystatin; Triamcinolone Ear drops
Kuvan Sapropterin dihydrochloride tablet
Lasix and Lasix High Dose Furosemide Infusion
Oral solution
Lynparza Olaparib capsule
m-Cefuroxime Cefuroxime injection
Nevanac Nepafenac Eye drops
Onbrez Breezehaler Indacaterol capsule
Osmitrol Mannitol Infusion
Patanol Olopatadine hydrochloride Eye drops
Potassium Chloride (Astra) Potassium Chloride Injection
Ramipex Pramipexole tablet
Simvastatin Mylan simvastatin tablet
Suxamethonium Chloride BP Suxamethonium injection
Temgesic Buprenorphine Injection
Terod Dutasteride capsule
Venclexta Venetoclax tablet
Xarelto Rivaroxaban Tablet
Zelboraf Vemurafenib Tablet
 

Additions to the Medsafe Website from 16 October – 3 November 2017


ABOUT MEDSAFE
Notice of Medsafe Office Closure Christmas/New Year 2017/2018please note these dates have changed!!!
 
CONSUMER INFORMATION
Consumer Information Leaflets
Taking metformin for gestational diabetes (PDF 255 KB, 2 pages)
 
MEDICINES
Influenza Vaccine Composition - this page has been updated
 
SAFETY INFORMATION
Where can I find information about vaccines? – this page has been updated
 
PUBLICATIONS
Hormonal Testing Preparations – this page has been updated
 
CONSULTATIONS
Outcome of consultation on changes to the Label Statements Database for sedating antihistamines available without a prescription
 

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Clustran sumatriptan injection
Elelyso taliglucerase alfa Injection
Ezetimibe Sandoz ezetimibe tablet
Fluconazole (Mylan) fluconazole capsule
Travopt travoprost eye drops
Updated
Tradename Active ingredient(s) Dose form
Alcaine proxymetacaine hydrochloride eye drops
Azopt brinzolamide eye drops
Betoptic betaxolol hydrochloride eye drops
Canesten clotrimazole thrush clotrimazole cream
pessary
Ciloxan ciprofloxacin hydrochloride eye drops
Cyclogyl cyclopentolate hydrochloride eye drops
Diclax SR diclofenac tablet
DuoTrav timolol; travoprost eye drops
Flucon fluorometholone eye drops
Fluorescite fluorescein injection
Frumil amiloride; furosemide tablet
Gardasil 9 Human papillomavirus (HPV) 11L1 Protein;
Human Papillomarivus (HPV) 16 L1 Protein
Human Papillomavirus (HPV) 18 L1 Protein;
Human Papillomavirus (HPV) 31 L1 Protein; Human Papillomavirus (HPV) 33 L1 Protein; Human Papillomavirus (HPV) 45 L1 Protein; Human Papillomavirus (HPV) 52 L1 Protein; Human Papillomavirus (HPV) 58 L1 Protein; Human papillomavirus (HPV) 6 L1 Protein
injection
Ibrance palbociclib capsule
Isopto Carpine pilocarpine hydrochloride eye drops
Lamivudine Alphapharm lamivudine tablet
Lantus
Lantus SoloStar
neutral insulin injection
Lioresal baclofen intrathecal solution
Maxidex dexamethasone eye drops
Maxidex dexamethasone eye ointment
Maxitrol dexamethasone; neomycin; polymyxin eye drops
Maxitrol dexamethasone; neomycin; polymyxin eye ointment
Mekinist trametinib tablet
Mobic meloxicam tablet
Mupider mupirocin ointment
Otezla apremilast tablet
Polaramine dexchlorpheniramine maleate tablet
Simbrinza brimonidine; brinzolamide eye drops
Sinemet carbidopa; levodopa tablet
Sinemet CR carbidopa; levodopa tablet
Sulprix amisulpride tablet
Tagrisso osimertinib tablet
Tobradex tobramycin eye drops
eye ointment
Truvada tenofovir disoproxil fumarate; emtricitabine tablet
Vesicare solifenacin tablet
Viread tenofovir disoproxil fumarate tablet
Xalkori crizotinib capsule
Zytiga abiraterone tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Elelyso taliglucerase alfa injection
Ezetimibe Sandoz ezetimibe tablet
Fluconazole (Mylan) fluconazole capsule
Rolin anastrozole tablet
Travopt travoprost eye drops
Updated
Tradename Active ingredient(s) Dose form
Advate octocog alfa injection
Alcaine proxymetacaine hydrochloride eye drops
Antabuse disulfiram tablet
Apo-Propranolol propranolol tablet
Azarga brinzolamide; timolol eye drops
Azopt brinzolamide eye drops
Betoptic betaxolol hydrochloride eye drops
Canesten clotrimazole thrush clotrimazole cream
pessary
Ciloxan ciprofloxacin hydrochloride eye drops
Clopidogrel Sandoz clopidogrel tablet
Cyclogyl cyclopentolate hydrochloride eye drops
Cymevene ganciclovir infusion
DBL Cytarabine cytarabine injection
DBL Desferrioxamine Mesylate desferoxamine mesylate injection
DBL Doxorubicin Hydrochloride doxorubicin hydrochloride injection
DBL Etoposide etoposide injection
DBL Fluorouracil fluorouracil injection
DBL Gemcitabine gemcitabine solution for injection
DBL Gemcitabine gemcitabine powder for injection
DBL Leucovorin Calcium leucovorin calcium injection
tablet
DBL Methotrexate methotrexate injection
tablet
Methotrexate Onco-Vial methotrexate injection
Deolate terbinafine tablet
Diclax SR diclofenac tablet
DuoTrav timolol; travoprost eye drops
Feiba NF factor VIII inhibitor bypassing fraction injection
Flucon fluorometholone eye drops
Fluorescite fluorescein injection
Frisium clobazam tablet
Gardasil 9 Human papillomavirus (HPV) 11L1 Protein;
Human Papillomarivus (HPV) 16 L1 Protein
Human Papillomavirus (HPV) 18 L1 Protein;
Human Papillomavirus (HPV) 31 L1 Protein; Human Papillomavirus (HPV) 33 L1 Protein; Human Papillomavirus (HPV) 45 L1 Protein; Human Papillomavirus (HPV) 52 L1 Protein; Human Papillomavirus (HPV) 58 L1 Protein; Human papillomavirus (HPV) 6 L1 Protein
injection
Glaumox acetazolamide injection
Hemosol BO calcium chloride; lactic acid; magnesium chloride; sodium bicarbonate; sodium chloride dialysis solution
Imovane zopiclone tablet
Keytruda pembrolizumab infusion
Lamivudine Alphapharm lamivudine tablet
Lioresal baclofen intrathecal solution
Losartan Actavis losartan tablet
Mabthera SC rituximab injection
Maxidex dexamethasone eye drops
eye Ointment
Maxitrol dexamethasone; neomycin; polymyxin eye drops
Mekinist trametinib tablet
Mobic meloxicam tablet
Mupider mupirocin ointment
Otezla apremilast tablet
Phoxilium calcium chloride; dibasic sodium phosphate; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride dialysis solution
Polaramine dexchlorpheniramine maleate tablet
Proveblue methylthioninium chloride hydrate injection
Recombinate octocog alfa injection
Rixubis nonacog gamma injection
Simbrinza brimonidine; brinzolamide eye drops
Simponi golimumab injection
Solu-Medrol methylprednisolone injection
Somatuline Autogel lanreotide injection
Sulprix amisulpride tablet
Tagrisso osimertinib tablet
Tobradex dexamethasone; tobramycin eye drops
eye ointment
Vepesid etoposide capsule
Vesicare solifenacin tablet
Xalkori crizotinib capsule
Zeffix lamivudine tablet
Zoloft sertraline tablet
Zytiga abiraterone tablet


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
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