Revised: 8 July 2020
About Medsafe
What's New
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 |
Additions to the Medsafe Website from 23-30 May 2020
COMMITTEEES
Medicines Adverse Reaction Committee
Agenda for the
182nd Medicines Adverse Reactions Committee meeting - 11 June 2020
SAFETY
Alert Communications
Miracle
Mineral Solution - dangerous and potentially life-threatening side
effects
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Bupivacaine Spinal Heavy BNM | Bupivacaine | injection |
| Capercit | Capecitabine | tablet |
| DeWorm Extra Strength | Mebendazole | tablet |
| Levonorgestrel BNM | Levonorgestrel | tablet |
| Nivestim | Filgrastim | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Betaloc CR | Metoprolol | tablet |
| Brilinta | Ticagrelor | tablet |
| Clozaril | Clozapine | tablet |
| Darzalex | Daratumumab | infusion |
| Erlyand | Apalutamide | tablet |
| Evista | Raloxifene | tablet |
| Kadcyla | Trastuzumab emtansine | infusion |
| Kaletra | Lopinavir; Ritonavir | tablet, oral solution |
| Kombiglyze XR | Metformin; Saxagliptin | tablet |
| Metoprolol IV Mylan | Metoprolol | injection |
| Neurontin | Gabapentin | capsule, tablet |
| Norvir | Ritonavir | tablet |
| Oxis | Formoterol | Turbuhaler |
| Panadol Extra | Caffeine; Paracetamol | tablet |
| Pentasa | Mesalazine | tablet |
| Pentasa | Mesalazine | suppository |
| Pentasa | Mesalazine | granules |
| Pentasa | Mesalazine | enema |
| Plaquenil | Hydroxychloroquine | tablet |
| Plendil ER | Felodipine | tablet |
| Pulmicort | Budesonide | Turbuhaler |
| Renvela | Sevelamer | tablet, oral suspension |
| Rydapt | Midostaurin | capsule |
| Sylvant | Siltuximab | infusion |
| Vimpat | Lacosamide | injection |
| Vimpat | Lacosamide | tablet, oral solution |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Bupivacaine Spinal Heavy BNM | Bupivacaine | injection |
| Capercit | Capecitabine | tablet |
| Levonorgestrel BNM | Levonorgestrel | tablet |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Betaloc CR | Metoprolol | tablet |
| Brilinta | Ticagrelor | tablet |
| Clozaril | Clozapine | tablet |
| Darzalex | Daratumumab | infusion |
| DBL™ Cytarabine | Cytarabine | injection |
| DBL™ Dexamethasone Sodium Phosphate | Dexamethasone | injection |
| DBL™ Oxaliplatin | Oxaliplatin | injection |
| DBL™ Phenytoin | Phenytoin | injection |
| Epilim | Valproic acid | tablet, syrup, liquid |
| Epilim | Valproic acid | IV |
| Erlyand | Apalutamide | tablet |
| Esbriet | Pirfenidone | capsule, tablet |
| Fasenra | Benralizumab | injection |
| Hydroxycarbamide | Hydroxycarbamide | capsule |
| Imbruvica | Ibrutinib | capsule, tablet |
| Imfinzi | Durvalumab | infusion |
| Influvac Tetra (Mylan) - Saison 2019/2020 | Influenza vaccine polyvalent | Injection |
| Jaqinus | Tofacitinib | tablet |
| Kadcyla | Trastuzumab emtansine | infusion |
| Kaletra | Lopinavir; Ritonavir | tablet, oral solution |
| Nimotop | Nimodipine | tablet, infusion |
| Nivestim | Filgrastim | injection |
| Norvir | Ritonavir | tablet |
| Opdivo | Nivolumab | infusion |
| Oxis | Formoterol | Turbuhaler |
| Panadol Extra | Caffeine; Paracetamol | tablet |
| Pentasa | Mesalazine | granules, tablet, suppository, enema |
| Plendil ER | Felodipine | tablet |
| Pulmicort | Budesonide | Turbuhaler |
| Rydapt | Midostaurin | capsule |
| Sylvant | Siltuximab | infusion |
| Tranexamic-AFT | Tranexamic acid | injection |
| Vimpat | Lacosamide | tablet, oral solution |
| Vimpat | Lacosamide | injection |
