Revised: 1 September 2019
About Medsafe
What's New
Additions to the Medsafe Website from 9-16 August 2019
COMMITTEES
Medicines Adverse Reactions Committee
MARC Reports for the 178th meeting
SAFETY
Monitoring Communication
Cathejell Lignocaine 2% Gel and reports of issues when using this medicine
Tramadol and opioid effects in breastfeeding babies - monitoring extended to 30 November 2019
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Avaxim | Hepatitis A vaccine | injection |
| Genvoya | Cobicistat; Elvitegravir; Emtricitabine; Tenofovir | tablet |
| Botox | Botulinum toxin type A | injection |
| Levothyroxine | Levothyroxine | tablet |
| Alanase 100 | Beclometasone | nasal spray |
| Alanse 50 | Beclometasone | nasal spray |
| Tagrisso | Osimertinib | tablet |
| Repatha | Evolocumab | injection |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| PiperTaz Sandoz | Piperacillin; Tazobactam | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| RA-Morph | Morphine | oral solution |
| Avaxim | Hepatitis A vaccine | injection |
| Hyalase | Hyaluronidase | injection |
| Tazocin EF | Piperacillin; Tazobactam | injection |
| Flumazenil-Baxter | Flumazenil | injection |
| Alanase 100 | Beclometasone | nasal spray |
| Brilinta | Ticagrelor | tablet |
| Tagrisso | Osimertinib | tablet |
| Tisseel | Aprotinin; Calcium chloride; Factor XIII; Fibrinogen; Thrombin | topical solution |
Additions to the Medsafe Website from 2 August-9 August 2019
The Medsafe website is now mobile friendly
If you are having trouble viewing it on your mobile, clear your
browsing history. Alternatively, email:
askmedsafe@health.govt.nz
COMMITTEES
Medicines Adverse Reactions Committee
MARC Reports for the 178th
meeting
SAFETY
Dear Healthcare Professional Letters
Femme-Tab (PDF
174 KB, 1 page)
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Fluox | Fluoxetine | capsule, tablet |
| Fotivda | Tivozanib | capsule |
| Maltofer | Iron polymaltose | tablet, syrup |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Butacort 50 mcg | Budesonide | nasal spray |
| Butacort 100 mcg | Budesonide | nasal spray |
| Diamide Relief | Loperamide | capsule |
| Enbrel | Etanercept | injection |
| EpiPen | Adrenaline | injection |
| Fentanyl Sandoz | Fentanyl | patch |
| Fucithalmic | Fusidic acid | eye drops |
| Glivec | Imatinib | tablet |
| Isoptin SR | Verapamil | tablet |
| Kaletra | Lopinavir; Ritonavir | tablet, oral solution |
| Keytruda | Pembrolizumab | infusion |
| MabThera SC | Rituximab | injection |
| Micreme | Miconazole | vaginal cream |
| Norvir | Ritonavir | tablet |
| Onglyza | Saxagliptin | tablet |
| Picato 0.015% | Ingenol mebutate | topical gel |
| Picato 0.05% | Ingenol mebutate | topical gel |
| Rapamune | Sirolimus | oral solution |
| Rapamune | Sirolimus | tablet |
| ReGen | Finasteride | tablet |
| Silvasta | Sildenafil | tablet |
| Suboxone | Buprenorphine; Naloxone | tablet |
| TOBI | Tobramycin | solution for inhalation |
| Yaz | Drospirenone; Ethinylestradiol | tablet |
| Zapril | Cilazapril | tablet |
| Zimybe | Ezetimibe; Simvastatin | tablet |
| Zyvox | Linezolid | tablet, infusion, oral suspension |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Advate | Octocog alfa | injection |
| Chloramphenicol | Chloramphenicol | ointment |
| Femme-Tab ED 20/100 | Ethinylestradiol; Levonorgestrel | tablet |
| Femme-Tab Ed 30/150 | Ethinylestradiol; Levonorgestrel | tablet |
| Fluox | Fluoxetine | capsule, tablet |
| Fotivda | Tivozanib | capsule |
| Maltofer | Iron polymaltose | tablet, syrup |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Botox | Botulinum toxin type A | injection |
| Butacort | Budesonide | nasal spray |
| Compound Sodium Lactate (Hartmanns) | Calcium chloride; Glucose; Lactic acid; Potassium chloride; Sodium chloride | infusion |
| DBL Fluorouracil | Fluorouracil | injection |
| Diamide Relief | Loperamide | capsule |
| Enbrel | Etanercept | injection |
| EpiPen | Adrenaline | injection |
| Fentanyl Sandoz | Fentanyl | patch |
| Glivec | Imatinib | tablet |
| Hydroxycarbamide | Hydroxycarbamide | capsule |
| Ibrance | Palbociclib | capsule |
| Isoptin SR | Verapamil | tablet |
| Kaletra | Lopinavir; Ritonavir | tablet, oral solution |
| Keytruda | Pembrolizumab | infusion |
| Losec | Omeprazole | capsule, tablet |
| Micreme | Miconazole | vaginal cream |
| Norvir | Ritonavir | tablet |
| Plasmalyte 148 in 5% Glucose | Glucose; Magnesium chloride; Potassium chloride; Sodium acetate; Sodium chloride; Sodium gluconate | infusion |
| Plasmalyte 56 in 5% Glucose | Glucose; Magnesium acetate; Potassium acetate; Sodium chloride | infusion |
| Plasmy-Lyte 148 | Magnesium chloride; Potassium chloride; Sodium acetate; Sodium chloride; Sodium gluconate | infusion |
| Potassium Chloride in Glucose and Sodium Chloride (Baxter) | Glucose; Potassium chloride; Sodium chloride | infusion |
| ReGen | Finasteride | tablet |
| Rifadin | Rifampicin | capsule, oral suspension, tablet, injection |
| Rubifen | Methylphenidate | tablet |
| Silvasta | Sildenafil | tablet |
| Stelara | Ustekinumab | injection, infusion |
| TMP | Trimethoprim | tablet |
| TOBI | Tobramycin | solution for inhalation |
| Yaz | Drospirenone; Ethinylestradiol | tablet |
| Zapril | Cilazapril | tablet |
| Zimybe | Ezetimibe; Simvastatin | tablet |
Additions to the Medsafe Website from 15 July-1 August 2019
COMMITTEES
Medicines Adverse Reactions Committee
Minutes of the 178th meeting
Medicines Classification Committee
Public Consultation on Agenda Items
Recent New Zealand Gazette Notices Relating to Classification
Reclassification of Vaccines
Terms of Reference
INFORMATION FOR INDUSTRY
Regulatory Consultants
Updated Fees – Effective from 1 July 2019
MEDICINES
Licensed Medicines Manufacturing Sites
PUBLICATIONS
Recent Official Information Act Releases
Request for information on sodium valproate (Epilim)
SAFETY
Dear Healthcare Professional Letters
Supply disruption for Cefaclor oral suspension and Acarbose tablets:
difference in reconstitution volume for Keflor granules
(PDF 222KB, 1 page)
MEDSAFE SAFETY COMMUNICATIONS
Alert Communication
Medsafe is issuing a warning to consumers to stop taking Go Lean Detox
and Go Detox – statement under section 98 of the Medicines Act 1981
Monitoring Communication
Update 31 July 2019 - Breast Implants and anaplastic large cell
lymphoma
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Keflor | cefaclor | oral suspension |
| Kisqali | ribociclib | tablet |
| Soliqua SoloStar | lixisenatide; neutral insulin | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Cosmegen | dactinomycin | injection |
| Feiba NF | factor VIII inhibitor bypassing fraction | injection |
| Letrole | letrozole | tablet |
| Noxafil | posaconazole | injection |
| Opiate Squill | opium; squill | linctus |
| Spinraza | nusinersen | injection |
| TMP | trimethoprim | tablet |
| Voltaren | diclofenac | suppository |
| Voltaren | diclofenac | injection |
| Voltaren D | diclofenac | dispersible tablet |
| Voltaren SR | diclofenac | tablet |
| Zeldox | ziprasidone | capsules |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Kisqali | ribociclib | tablet |
| Pro-Banthine | propantheline | tablet |
| Soliqua SoloStar | lixisenatide; neutral insulin | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Capoten | captopril | oral liquid |
| Cosmegen | dactinomycin | injection |
| Firazyr | icatibant | injection |
| Invanz | ertapenem | injection |
| Keflor | cefaclor | oral suspension |
| Letrole | letrozole | tablet |
| Loceryl | amorolfine | nail laquer |
| Noxafil | posaconazole | injection |
| Opiate Squill | opium; squill | linctus |
| Sotacor | sotalol | tablet |
| Spinraza | nusinersen | injection |
| Urex Forte | furosemide | tablet |
| Voltaren | diclofenac | tablet |
| Zincaps | zinc sulfate | capsules |
Additions to the Medsafe Website from 8 July - 15 July 2019
Committees
Medicines Classification Committee
Agenda for the 63rd Medicines Classification Committee Meeting
Dates and Deadlines
Consultations
Changes to the prescribing restrictions for riluzole
Medicinal Cannabis Scheme
consultation Closes 7 Aug 2019
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Alphamox | Amoxicillin | capsule |
| Apo-Propranolol | Propranolol | tablet |
| Crusia-AFT | Enoxaparin sodium | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Aclin | Sulindac | tablet |
| Advate | Octocog alfa | injection |
| Brufen | Ibuprofen | tablet |
| Brufen 200 mg | Ibuprofen | tablet |
| Brufen Extra | paracetamol; ibuprofen | tablet |
| Brufen One | Ibuprofen | tablet |
| Brufen SR | Ibuprofen | tablet |
| Celostea | Celecoxib | capsule |
| Cystadane | Betaine | oral solution |
| Duavive | Bazedoxifene; Conjugated estrogens | tablet |
| Epilim | Valproic acid | injection, tablet, oral solution |
| Exelon | Rivastigmine | patch |
| FluQuadri | Influenza vaccine polyvalent; Influenza virus B/Colorado/06/2017 - like strain | injection |
| Hybloc | Labetalol | tablet |
| Ibuprofen Relieve | Ibuprofen | tablet |
| Lorstat | Atorvastatin | tablet |
| Noflam | Naproxen | tablet |
| Noxafil | Posaconazole | oral suspension, tablet |
| Noxafil | Posaconazole | injection, tablet, oral solution |
| Precedex | Dexmedetomidine | infusion |
| Sandomigran | Pizotifen | tablet |
| Symbicort | Budesonide; Formoterol | inhalation powder |
| Synflorix | Pneumococcal vaccine | injection |
| Tecentriq | Atezolizumab | infusion |
| Tilcotil | Tenoxicam | tablet |
| Voltaren | Diclofenac | suppository |
| Voltaren | Diclofenac | injection |
| Voltaren SR | Diclofenac | tablet |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Alphamox | Amoxicillin | capsule |
| Crusia-AFT | Enoxaparin sodium | injection |
| Isentress | Raltegravir | tablet |
| Paracetamol Osteo-Tab | Paracetamol | tablet |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Aclin | Sulindac | tablet |
| Arrow-Quinapril | Quinapril | tablet |
| Bisolvon Dry | Dextromethorphan | pastilles |
| Bisolvon Dry | Dextromethorphan | oral solution |
| Brufen | Ibuprofen | tablet |
| Brufen 200 mg | Ibuprofen | tablet |
| Brufen Extra | paracetamol; ibuprofen | tablet |
| Brufen One | Ibuprofen | tablet |
| Brufen SR | Ibuprofen | tablet |
| Celostea | Celecoxib | capsule |
| Clopine | Clozapine | oral suspension , tablet |
| Cystadane | Betaine | oral solution |
| Daivonex | Calcipotriol | ointment |
| Decozol | Miconazole | oral gel |
| Eltroxin | Levothyroxine | tablet |
| Epilim | Valproic acid | tablet, injection, oral solution, syrup |
| Exelon | Rivastigmine | patch |
| Fenpaed | Ibuprofen | oral suspension |
| FluQuadri | Influenza vaccine polyvalent; Influenza virus B/Colorado/06/2017 - like strain | injection |
| Fucicort | Betamethasone; Fusidic acid | cream |
| Hemlibra | Emicizumab | injection |
| Hybloc | Labetalol | tablet |
| Ibuprofen Relieve | Ibuprofen | tablet |
| Locorten-Vioform | Clioquinol; Flumetasone | ear drops |
| Lorstat | Atorvastatin | tablet |
| MabThera SC | Rituximab | injection |
| Noflam | Naproxen | tablet |
| Noxafil | Posaconazole | oral suspension, tablet |
| Noxafil | Posaconazole | injection |
| Olbetam | Acipimox | capsule |
| Ondansetron-Baxter | Ondansetron | injection |
| Orencia | Abatacept | injection |
| Rapamune | Sirolimus | oral solution, tablet |
| Sandomigran | Pizotifen | tablet |
| Solu-Cortef ACT-O-Vial | Hydrocortisone | injection |
| Suxamethonium (Max Health) | Suxamethonium | injection |
| Symbicort | Budesonide; Formoterol | inhalation powder |
| Synflorix | Pneumococcal vaccine | injection |
| Tamiflu | Oseltamivir | capsule, oral supension |
| Tilcotil | Tenoxicam | tablet |
| Voltaren | Diclofenac | suppository |
| Voltaren | Diclofenac | injection |
| Voltaren D | Diclofenac | tablet |
| Voltaren SR | Diclofenac | tablet |
| Zinforo | Ceftaroline | injection |
| Zusdone | Ziprasidone | capsule |
