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
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