About Medsafe

Revised: 19 September 2018

What's New

Additions to the Medsafe Website from 1-14 September 2018


Devices
The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication

Publications
Prescriber Update - September 2018

CONSUMER MEDICINE INFORMATION
New
Tradename Dose form Active ingredient(s)
Apo-Olanzapine Tablet olanzapine
Binocrit Injection erythropoietin
Hemlibra Injection emicizumab
Metoprolol Mylan Injection metoprolol
Rabipur Injection rabies vaccine
Solifenacin Succinate Max Health Tablet solifenacin
Tasigna Capsule nilotinib
Updated
Tradename Dose form Active ingredient(s)
Alecensa capsule alectinib
Dilantin capsule, tablet, oral suspension phenytoin
Felo 5 ER & 10 ER tablet felodipine
Flucazole capsule fluconazole
Gamunex infusion normal immunoglobulin
Keytruda infusion pembrolizumab
Lamictal tablet lamotrigine
Myloc CR tablet metoprolol
OncoTICE injection BCG vaccine
Panzop Relief tablet pantoprazole
Ranitidine Relief tablet ranitidine
Rifadin injection rifampicin
Rifadin capsule, oral suspension, tablet rifampicin
Singulair tablet montelukast
Stelara Injection, infusion ustekinumab
Tobramycin Mylan injection tobramycin
Venclexta tablet venetoclax
Xolair injection omalizumab
Zostavax injection varicella vaccine
Zypine tablet olanzapine
Zypine® ODT wafer olanzapine
DATA SHEETS
New
Tradename Dose form Active ingredient(s)
Bosentan Dr Reddy's tablet bosentan
Hemlibra injection emicizumab
Lipitor tablet atorvastatin
Mitomycin injection mitomycin
Rabipur injection rabies vaccine
Updated
Tradename Dose form Active ingredient(s)
Alecensa capsule alectinib
Apo-Olanzapine tablet olanzapine
Binocrit injection erythropoietin
Celazadine injection azacitidine
Clarithromycin infusion clarithromycin
Felo 5 ER & 10 ER tablet felodipine
Flucazole capsule fluconazole
Gamunex infusion normal immunoglobulin
Inspra tablet eplerenone
Keytruda infusion pembrolizumab
Lamictal tablet lamotrigine
Metformin tablet metformin
Myloc CR tablet metoprolol
Nurofen 400 tablet ibuprofen
OncoTICE injection BCG vaccine
Orencia injection abatacept
Panzop Relief tablet pantoprazole
Ranitidine Relief tablet ranitidine
Rifadin injection, capsule, oral suspension, tablet rifampicin
SimStatin tablet simvastatin
Singulair tablet montelukast
Stelara injection, infusion ustekinumab
Sutent capsule sunitinib
Tasigna capsule nilotinib
Venclexta tablet venetoclax
Xeomin injection Botulinum toxin type A
Xolair injection omalizumab
ZAP gel benzocaine; tetracaine
Zarator tablet atorvastatin
Zostavax injection varicella vaccine
Zypine tablet olanzapine
Zypine® ODT wafer olanzapine


News and Events added to the Medsafe Website from 1-31 August 2018

Date Type Title
6 September 2018 Publications Prescriber Update - September 2018
5 September 2018 Alert Communication The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication
30 August 2018 Committees Medicines Adverse Reactions Committee - Agenda for the 175th  meeting - 13 September 2018
21 August 2018 Committees Medicines Adverse Reactions Committee - Minutes of the 174th meeting - 3 July 2018
20 August 2018 Dear Healthcare Professional Letter Dilantin (PDF 209 KB, 2 Pages) - Clarification regarding Dilantin Dear Healthcare Professional Letter dated 19 July 2018
17 August 2018 Committees The searchable Medicine Classification Database has been updated with the changes in the latest Gazette notice
14 August 2018 Monitoring Communication M² Logo Isotretinoin and Obsessive Compulsive Disorder (OCD)
13 August 2018 Alert Communication Codeine – new restrictions on use in children and young adults
13 August 2018   Bicillin (PDF 1,135 KB, 4 Pages) -  Changes to expression of product strength
9 August 2018 Committees Medicines Adverse Reactions Committee - Vacancies
9 August 2018 Committees Medicines Classification Committee - Dates and Deadlines
9 August 2018 Committees Medicines Classification Committee - Agenda for the 61st meeting
8 August 2018 Committees A valid objection has been received regarding the following recommendation Modified-release paracetamol – proposed reclassification from pharmacy-only medicine to restricted medicine
7 August 2018 Surgical Mesh Adverse Event Reports relating to Surgical Mesh Implants dated August 2018 (PDF 16 pages, 294KB)
7 August 2018 Surgical Mesh All the surgical mesh information has been moved to a new surgical mesh area with a new Landing Page
6 August 2018 Monitoring Communication Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy
27 July 2018 Medicine Consumer Level Recall - Melatonin 3mg tablets
25 July 2018 Consumer Information Leaflets Taking metformin for gestational diabetes (Te Reo version) (PDF 236 KB, 2 pages)
Taking metformin for gestational diabetes (Samoan version) (PDF 243 KB, 2 pages)
24 July 2018 Committees Minutes of the 60th meeting of the Medicines Classification Committee - Secretary's Note has been added to item 6.3 on Influenza vaccine
19 July 2018 Dear Healthcare Professional Letter Dissolution profile of Dilantin® 30 mg and 100 mg capsules (New Formulation)
3 July 2018 Dear Healthcare Professional Letter Provisional Consent of Neulactil periciazine 2.5mg and 10mg tablets (Hong Kong stock) to cover temporary stock shortage (PDF 78 KB, 2 pages)


Datasheets and CMI added to the Medsafe Website from 1-31 August 2018

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Chloramphenicol LINK chloramphenicol injection
Cinacalcet Te Arai cinacalcet injection
Pitressin argipressin injection
Spinraza nusinersen injection
Updated
Tradename Active ingredient(s) Dose form
Acupan nefopam tablet
Bosentan Mylan bosentan tablet
Butacort 100 budesonide nasal spray
Butacort 50 budesonide nasal spray
Daivobet betamethasone; calcipotriol ear drops
Dilantin phenytoin capsule
suspension
tablet
Dymista azelastine; fluticasone nasal spray
Firazyr icatibant injection
Flucon fluorometholone eye drops
Gilenya fingolimod capsule
Haldol haloperidol injection
Maviret glecaprevir; pibrentasvir tablet
Maxidex Drops dexamethasone eye drops
Maxidex Ointment dexamethasone eye ointment
Maxitrol Drops dexamethasone; neomycin; polymyxin eye drops
Maxitrol Ointment dexamethasone; neomycin; polymyxin eye ointment
Methyldopa methyldopa tablet
Myocrisin aurothiomalate injection
Ofev nintedanib capsule
Pacifen baclofen tablet
Perjeta pertuzumab infusion
Plegridy peginterferon beta-1a injection
Sotalol sotalol tablet
Staphlex flucloxacillin capsule
TMP trimethoprim tablet
Tobradex dexamethasone; tobramycin eye drops
Triumeq abacavir; dolutegravir; lamivudine tablet
Tykerb lapatinib tablet
Vedafil (pharmacist supply) sildenafil tablet
Vedafil (prescription) sildenafil tablet
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Canesten Extra clotrimazole; hydrocortisone cream
Canesten Plus clotrimazole; hydrocortisone cream
Chloramphenicol Link chloramphenicol injection
Cinacalcet Te Arai cinacalcet tablet
Leuprorelin Sandoz leuprorelin implant
Metoprolol Mylan metoprolol injection
Pitressin argipressin injection
Solifenacin Succinate solifenacin tablet
Spinraza nusinersen injection
Updated
Tradename Active ingredient(s) Dose form
Acupan nefopam tablet
Anexate flumazenil injection
Antabuse disulfiram tablet
Apo-Diltiazem CD dilitazem capsule
Apomorphine apomorphine infusion
Arrow-Clopid clopidogrel tablet
Baraclude entecavir tablet
Bimatoprost Multichem bimatoprost eye drops
Biodone methadone oral solution
Bosentan Mylan bosentan tablet
Brilinta ticagrelor tablet
Butacort budesonide nasal spray
Ciproxin HC ciprofloxacin; hydrocortisone ear drops
DBL Zoledronic Acid zoledronic acid infusion
Depo-Medrol with Lidocaine lidocaine; methylprednisolone injection
Dymista azelastine; fluticasone nasal spray
Endoxan cyclophosphamide injection
Firazyr icatibant injection
Flucon fluorometholone eye drops
Gilenya fingolimod capsule
Haldol haloperidol injection
Invega paliperidone tablet
Invega Sustenna paliperidone injection
Invega Trinza paliperidone injection
Latisse bimatoprost solution
Lumigan bimatoprost eye drops
Lumigan PF bimatoprost eye drops
Maviret glecaprevir; pibrentasvir tablet
Maxidex dexamethasone eye drops
eye ointment
Maxitrol dexamethasone; neomycin; polymyxin eye drops
eye ointment
Methyldopa methyldopa tablet
Minims Pilocarpine pilocarpine eye drops
NeoRecormon epoetin beta injection
Onkotrone mitoxantrone injection
Pacifen baclofen tablet
Perjeta pertuzumab infusion
Proleukin aldesleukin injection
Rapamune sirolimus tablet
oral solution
Remicade infliximab injection
Resolve Plus 0.5 hydrocortisone; miconazole; cream
Resolve Plus 1.0 hydrocortisone; miconazole; cream
Risperdal risperidone tablet
oral solution
Risperdal Consta risperidone injection
Seroquel quetiapine tablet
Solu-Medrol methylprednisolone injection
Sotalol sotalol tablet
Staphlex flucloxacillin capsule
Synagis palivizumab injection
Tasigna nilotinib capsule
Tmp trimethoprim tablet
Tobradex dexamethasone; tobramycin eye drops
eye ointment
Tobramycin Mylan tobramycin injection
Tykerb lapatinib tablet
Uromitexan mesna injection
Uromitexan mesna tablet
Vedafil sildenafil tablet
Viekira Pak dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
Viekira Pak-RBV dasabuvir; ombitasvir; paritaprevir; ritonavir tablet
Zeffix lamivudine oral solution
Zeffix lamivudine tablet


Additions to the Medsafe Website from 23-31 July 2018


COMMITTEES

Medicines Classification Committee
Minutes of the 60th meeting of the Medicines Classification Committee - Secretary's Note has been added to item 6.3 on Influenza vaccine

Proposed Agenda for the 56th meeting of the Medicines Classification Committee on Natural Health Products – Secretary’s Note has been added

Dates and Deadlines has been updated

SAFETY INFORMATION
Early Warning System – Alert Communication
Consumer Level Recall - Melatonin 3mg tablets

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Bexsero Neisseria meningitidis vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Glucobay acarbose tablet
ReGen finasteride tablet
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Zimybe ezetimibe; simvastatin tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Bexsero Neisseria meningitidis vaccine injection
Updated
Tradename Active ingredient(s) Dose form
Ascor L 500 ascorbic acid injection
Colifoam hydrocortisone enema
Crestor rosuvastatin tablet
DermAid hydrocortisone topical cream
DermAid Soft hydrocortisone topical cream
DP Lotion-HC hydrocortisone topical cream
Holoxan ifosfamide injection
Mestinon pyridostigmine tablet
Oxycodone (Boucher & Muir) oxycodone tablet
Tivicay dolutegravir tablet
Triumeq abacavir; dolutegravir; lamivudine tablet
Zimybe ezetimibe; simvastatin tablet