Revised: 1 October 2020
About Medsafe
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
| 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 |
