Revised:  1 October 2020

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What's New

Additions to the Medsafe Website from 18 August to 29 September 2020


COMMITTEES
Medicines Classification Committee
Agenda for the 65th Medicines Classification Committee meeting
Dates and Deadlines
Minutes of the 64th meeting of the Medicines Classification Committee - 9 July 2020
 
CONSULTATION
Outcome
Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions
 
PUBLICATIONS
Media
Medsafe takes action to prevent the supply of illegally marketed medicine linked to liver harm
 
Medsafe has completed its review of Objections from the 64th Medicines Classification Committee to reclassify pholcodine
 
Prescriber Update
Prescriber Update 41(3) - September 2020
 
SAFETY
Alert Communication
Medsafe is issuing a warning that Elevacity Elevate Smart Coffee (Version 3) should not be consumed - statement under section 98 of the Medicines Act 1981
 
Update - Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) - Reports of false positives presenting as faint lines and inconclusive results
 
Monitoring Communication
Possible risk of psoriasis exacerbation with bupropion
 

CONSUMER MEDICINE INFORMATION
New    
Tradename Active ingredient(s) Dose form
Betadine Sore Throat Gargle Ethanol; Povidone-iodine mouthwash solution
Betadine Antiseptic Liquid Spray Povidone-iodine liquid spray
Hospira Methotrexate Methotrexate injection
Methoblastin PFS Methotrexate injection
Pravastatin Mylan Pravastatin tablet
Updated    
Tradename Active ingredient(s) Dose form
Abilify Aripiprazole tablet
Act-HIB Haemophilus influenzae type b vaccine injection
Betadine Antiseptic Topical Ointment Povidone-iodine topical ointment
Bupivacaine Spinal Heavy BMN Bupivacaine injection
Cotellic Cobimetinib tablet
Eloxatin Oxaliplatin infusion
Imovane Zopiclone tablet
Jadelle Levonorgestrel implant
Logem Lamotrigine tablet
Ozole Fluconazole capsule
Panadol Osteo Paracetamol tablet
PipTaz Sandoz Piperacillin; Tazobactam injection
Rozlytrek Entrectinib capsule
Stelara Ustekinumab injection; infusion
Stocrin Efavirenz tablet
Tamoxifen Sandoz Tamoxifen tablet
Veletri Epoprostenol injection
Vergo 16 Betahistine tablet
DATA SHEETS
New    
Tradename Active ingredient(s) Dose form
Intralipid Soya oil infusion
Pravastatin Mylan Pravastatin tablet
Updated    
Tradename Active ingredient(s) Dose form
Abilify Aripiprazole tablet
Act-HIB Haemophilus influenzae type b vaccine injection
Ambrisentan Mylan Ambrisentan tablet
Baraclude Entecavir tablet
Belkyra Deoxycholic acid injection
Boostrix Diphtheria vaccine; Pertussis vaccine; Tetanus vaccine injection
Bupivacaine Spinal Heavy BMN Bupivacaine injection
Cefepime Kabi Cefepime injection
Cerezyme Imiglucerase infusion
Cotellic Cobimetinib tablet
Darunavir Mylan Darunavir tablet
Daunorubicin Pfizer Daunorubicin injection
DBL™ Fluorouracil Fluorouracil injection
Descovy Emtricitabine; Tenofovir tablet
Eylea Aflibercept injection
Hospira Methotrexate Methotrexate injection
Ibuprofen Ibuprofen suspension
Jadelle Levonorgestrel implant
Jakavi Ruxolitinib tablet
Jardiamet Empagliflozin; Metformin tablet
Jardiance Empagliflozin tablet
Kisqali Ribociclib tablet
Levetiracetam-AFT Levetiracetam solution
Logem Lamotrigine tablet
Lucentis Ranibizumab injection
Methoblastin PFS Methotrexate injection
Nimenrix Neisseria meningitidis Group C polysaccharide injection
Ondansetron Kabi Ondansetron injection
Panadol Osteo Paracetamol tablet
Paracetamol (Pharmacare) Paracetamol tablet
Paracetamol Osteo-Tab Paracetamol tablet
Penicillin G Sodium Benzylpenicillin injection
RiaSTAP Fibrinogen injection
Stelara Ustekinumab injection; infusion
Stocrin Efavirenz tablet
Sustanon 250 Testosterone injection
Tamoxifen Sandoz Tamoxifen tablet
Tasigna Nilotinib capsule
Tecentriq Atezolizumab infusion
Vergo 16 Betahistine tablet

Additions to the Medsafe Website from 1-17 August 2020

 

Committees
Medicines Adverse Reaction Committee
Minutes
Minutes of the 182nd medicines adverse reactions committee meeting – Item 3.1.1  Consideration of Cathejell (lignocaine) 2% gel under section 36 of the Medicines Act 1981 have been added

 Reports
3.1.1  Consideration of Cathejell (lignocaine) 2% gel under section 36 of the Medicines Act 1981 (pdf 482 KB, 13 pages)

Medicines Classification Committee
Dates and Deadlines

Information for Industry
Current Guidelines on the Regulation of Therapeutic Products in New Zealand

Part 8: Pharmacovigilance Edition 2.2 and Summary of Changes made

CONSUMER MEDICINE INFORMATION
New    
Tradename Active ingredient(s) Dose form
Somatuline Autogel Lanreotide injection
Updated    
Tradename Active ingredient(s) Dose form
Aimovig Erenumab injection
Azopt Brinzolamide eye drops
Betoptic Betaxolol eye drops
Bridion Sugammadex injection
Celostea Celecoxib capsule
Ciloxan Ciprofloxacin eye drops
Ciproxin HC Otic Ciprofloxacin; Hydrocortisone ear drops
Cosentyx Secukinumab injection
Estradot Estradiol patch
Fluorouracil Accord Fluorouracil injection
Foradil Formoterol capsule
Galvus Vildagliptin tablet
Humira Adalimumab injection
Invega Sustenna Paliperidone injection
Invega Trinza Paliperidone injection
Lomide Lodoxamide eye drops
Mersyndol Codeine; Doxylamine; Paracetamol tablet
Risperdal Consta Risperidone injection
Risperdal Risperidone tablet, oral solution
Rubifen Methylphenidate tablet
Rydapt Midostaurin capsule
Solifenacin Mylan Solifenacin tablet
Venofer Iron sucrose injection
Verpamil Verapamil tablet
Vttack Voriconazole tablet
DATA SHEETS
New    
Tradename Active ingredient(s) Dose form
Dimetapp Cough & Cold Brompheniramine; Dextromethorphan; Phenylephrine Elixir
Updated    
Tradename Active ingredient(s) Dose form
Aimovig Erenumab injection
Apo-Ondansetron Ondansetron tablet
Azopt Brinzolamide eye drops
Betoptic Betaxolol eye drops
Bridion Sugammadex injection
Celostea Celecoxib capsule
Ciloxan Ciprofloxacin eye drops
Ciproxin HC Otic Ciprofloxacin; Hydrocortisone ear drops
Cosentyx Secukinumab injection
Eloxatin Oxaliplatin infusion
Erythrocin IV Erythromycin powder for injection
Estradot Estradiol patch
Fluorouracil Accord Fluorouracil injection
Foradil Formoterol capsule
Galvus Vildagliptin tablet
Ginet Cyproterone; Ethinylestradiol tablet
Glucose 5% Freeflex Glucose infusion
Imovane Zopiclone tablet
Invega Sustenna Paliperidone injection
Invega Trinza Paliperidone injection
Lomide Lodoxamide eye drops
Risperdal Consta Risperidone injection
Risperdal Risperidone tablet, oral solution
Rozlytrek Entrectinib capsule
Rubifen Methylphenidate tablet
Rydapt Midostaurin capsule
Siterone Cyproterone tablet
Solifenacin Mylan Solifenacin tablet
Somatuline Autogel Lanreotide injection
Sustanon Testosterone injection
Takhzyro Lanadelumab injection
Trexate Methotrexate tablet
Venofer Iron sucrose injection
Verpamil Verapamil tablet
VPRIV Velaglucerase alfa infusion
Vttack Voriconazole tablet
   

Additions to the Medsafe Website from 3 July to 31 July 2020

Committees
Medicines Adverse Reactions Comittee
Minutes of the 182nd Medicines Adverse Reactions Committee meeting

Medicines Classification Committee
Medicines Classification Committee - Reclassification of Codeine

Safety
Monitoring Communications
Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy

M2 logo Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) - Reports of false positives presenting as faint lines and inconclusive results

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Elocon Mometasone ointment, cream, lotion
Menopur Menotrophin injection
Updated
Tradename Active ingredient(s) Dose form
Asamax Mesalazine tablet
Betaferon Interferon beta injection
Clopine Clozapine tablet, suspension
Cosentyx Secukinumab injection
Dermol Scalp Clobetasol lotion
Dostinex Cabergoline tablet
Fasenra Benralizumab injection
Faslodex Fulvestrant injection
Fluconazole (Mylan) Fluconazole capsule
Flutamin Flutamide tablet
Kisqali Ribociclib tablet
Lucentis Ranibizumab injection
Lucrin Depot Leuprorelin injection
Mydriacyl Tropicamide eye drops
Norspan Buprenorphine transdermal patch
Pravastatin Sodium Pravastatin tablet
Procur Cyproterone tablet
Sandostatin LAR Octreotide injection
Staphlex Flucloxacillin capsule
Tegretol Carbamazepine tablet, syrup
Teriflunomide Sandoz Teriflunomide tablet
Xarelto Rivaroxaban tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Diclofenac 25 Diclofenac tablet
Inovelon Rufinamide tablet
Menopur Menotrophin injection
Updated
Tradename Active ingredient(s) Dose form
Asamax Mesalazine tablet
Betaferon Interferon beta injection
Caelyx Doxorubicin infusion
Calcium Chloride Calcium chloride injection
Cosentyx Secukinumab injection
Dermol Scalp Clobetasol lotion
Diclofenac Devatis Diclofenac eye drops
Efudix Fluorouracil cream
Estelle-35 Cyproterone; Ethinylestradiol tablet
Fasenra Benralizumab injection
Faslodex Fulvestrant injection
Fluconazole (Mylan) Fluconazole capsule
Flumazenil-Baxter Flumazenil injection
Flutamin Flutamide tablet
Lucrin Depot Leuprorelin injection
Martindale Pharma® Acetylcysteine Acetylcysteine infusion
Motetis Tetrabenazine tablet
Mydriacyl Tropicamide eye drops
Norspan Buprenorphine transdermal patch
Ondansetron-Baxter Ondansetron injection
Oxaliplatin Accord Oxaliplatin infusion
Ozole Fluconazole capsule
Pexsig Perhexiline tablet
Pravastatin Sodium Pravastatin tablet
Riximyo Rituximab infusion
Sandostatin LAR Octreotide injection
Staphlex Flucloxacillin capsule
Tagrisso Osimertinib tablet
Tegretol Carbamazepine tablet, syrup
Teriflunomide Sandoz Teriflunomide tablet
Varenicline Pfizer Varenicline tablet
Vesicare Solifenacin tablet
Xalkori Crizotinib capsule
Xarelto Rivaroxaban tablet
Zinforo Ceftaroline injection

Additions to the Medsafe Website from 14 June to 2 July 2020


COMMITTEES
Medicines Classification Committee
Agenda for the 64th Medicines Classification Committee meeting
The date of the meeting has been changed to 9 July 2020
 
Comments on agenda items for the 64th meeting of the Medicines Classification Committee to be held on 9 July 2020
 
Dates and Deadlines has been updated
 
MEDICINES
Medicines with Restrictions
Sativex® Oromucosal Spray

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Beta Scalp Application betamethasone lotion
Botox botulinum toxin type A injection
Daivobet betamethasone; calcipotriol gel
Daivobet betamethasone; calcipotriol ointment
Daivonex calcipotriol ointment
Dukoral cholera vaccine oral suspension
Ferodan ferrous sulfate oral solution
Saxenda liraglutide injection
Spiriva tiotropium capsule
Tamiflu oseltamivir oral suspension
Tramal tramadol capsule, injection
Tramal SR tramadol tablet
Zarzio filgrastim injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Dimetapp Cough & Cold Colour Free brompheniramine; dextromethorphan; phenylephrine elixir
Dimetapp Cough Cold & Flu Decongestant Day & Night chlorphenamine; dextromethorphan; paracetamol; phenylephrine capsule
Dimetapp Cough Cold & Flu Night Relief chlorphenamine; dextromethorphan; paracetamol; phenylephrine capsule
Dimetapp Cough, Cold & Flu Day + Night dextromethorphan; doxylamine; paracetamol capsule
Dimetapp Multi Symptom Cough Cold & Flu dextromethorphan; paracetamol; phenylephrine capsule
Robitussin Cough & Chest Congestion dextromethorphan; guaifenesin oral solution
Robitussin Dry Cough Liquid Filled Capsules dextromethorphan capsules
Robitussin Dry Cough Forte dextromethorphan oral solution
TopiDerm hydrocortisone cream
Updated
Tradename Active ingredient(s) Dose form
Act-HIB haemophilus influenzae type b vaccine injection
Beta Scalp Application betamethasone lotion
Botox botulinum toxin type A injection
Clopine clozapine tablet
Daivonex calcipotriol ointment
DBL® Methotrexate methotrexate injection
Diclofenac Devatis diclofenac eye drops
Enbrel etanercept injection
Ferodan ferrous sulfate oral solution
Fluorescite fluorescein injection
Ketamine-Baxter ketamine injection
Methoblastin methotrexate tablet
Neurontin gabapentin capsule
Octreotide (Max Health) octreotide injection
Procur cyproterone tablet
RiaSTAP fibrinogen injection
Saxenda liraglutide injection
Synthamin alanine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine infusion
Tagrisso osimertinib tablet
Tracrium atracurium injection
Tramal tramadol capsule, injection
Tramal SR tramadol tablet
Zarzio filgrastim injection
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