Revised:  17 August 2020

About Medsafe

What's New

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

Additions to the Medsafe Website from 8 to 14 June 2020


SAFETY
Alert Communication
Important updates to clozapine data sheets and monitoring during covid-19 pandemic

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Gees Linctus Opium; Squill linctus
Zavicefta Ceftazidime; Avibactam infusion
Updated
Tradename Active ingredient(s) Dose form
Adacel Diphtheria vaccine; Pertussis vaccine; Tetanus vaccine injection
Augmentin Amoxicillin; Clavulanic acid suspension
Azol Danazol capsule
Bridion Sugammadex injection
Byetta Exenatide injection
Mavenclad Cladribine tablet
Modavigil Modafinil tablet
Onglyza Saxagliptin tablet
Ponstan (Prescription) Mefenamic acid capsule
Ponstan (OTC pack) Mefenamic acid capsule
Promozio Atovaquone; Proguanil tablet
VFEND Voriconazole tablet, oral suspension, injection
Vivotif Oral Typhoid vaccine capsule
Xifaxan Rifaximin tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
0.9% Sodium Chloride (Viaflo) Sodium chloride infusion
Gees Linctus Opium; Squill linctus
Merck Cladribine Cladribine tablet
Zavicefta Ceftazidime; Avibactam infusion
Updated
Tradename Active ingredient(s) Dose form
Augmentin Amoxicillin; Clavulanic acid tablet, suspension
Azol Danazol capsule
Biostate Factor VIII, human; von Willebrand's factor : Ristocetin cofactor injection
Bridion Sugammadex injection
Cyclizine Lactate (Hameln) Cyclizine injection
Forteo Teriparatide injection
Fucidin Fusidic acid tablet
Mavenclad Cladribine tablet
Modavigil Modafinil tablet
Normal Immunoglobulin-VF Immunoglobulin G injection
Opdivo Nivolumab infusion
OxyNorm Oxycodone capsule, oral solution
OxyNorm Oxycodone injection
Ponstan (Prescription) Mefenamic acid capsule
Ponstan (OTC pack) Mefenamic acid capsule
Resotrans Prucalopride tablet
VFEND Voriconazole tablet, oral suspension, injection
Vivotif Oral Typhoid vaccine capsule

Additions to the Medsafe Website from 30 May – 7 June 2020


PUBLICATIONS
Prescriber Update
Prescriber Update 41(2) - June 2020

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Bexsero Meningococcal vaccine injection
Dosulepin Mylan dosulepin tablet
Eprex erythropoietin injection
Esmeron rocuronium injection
Neorecormon erythropoietin injection
Panadol Rapid paracetamol tablet
Pradaxa dabigatran capsule
Repatha evolocumab injection
Tysabri natalizumab infusion
Zoladex 10.8mg goserelin injection
Zoladex 3.6mg goserelin injection
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Brevinor-1 28 Day ethinylestradiol; norethisterone tablet
Versacloz clozapine oral suspension
Updated
Tradename Active ingredient(s) Dose form
Adacel diphtheria vaccine; pertussis vaccine; tetanus vaccine injection
Bexsero Meningococcal vaccine injection
Calcium Chloride 10% calcium chloride injection
DBL™ Diazoxide diazoxide injection
Diclofenac Devatis diclofenac eye drops
Dosulepin Mylan dosulepin tablet
Elaprase idursulfase infusion
Enstilar betamethasone; calcipotriol foam
Eprex erythropoietin injection
Esmeron rocuronium injection
Kyprolis carfilzomib infusion
Lynparza olaparib capsule
Neorecormon erythropoietin injection
Ondansetron ODT-DRLA ondansetron tablet
OxyNorm oxycodone capsule, oral solution
OxyNorm oxycodone injection
Panadol Rapid paracetamol tablet
Pradaxa dabigatran capsule
Prozac fluoxetine capsule
Repatha evolocumab injection
Tysabri natalizumab infusion
Ventavis iloprost inhalation
Zoladex 10.8mg goserelin injection
Zoladex 3.6mg goserelin injection
Zyprexa Relprevv olanzapine injection

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