Revised: 31 May 2020
About Medsafe
What's New
Additions to the Medsafe Website from 8-22 May 2020
MEDIA RELEASE
Artemisia Annua extract becomes prescription only medicine
SAFETY
Monitoring Communications
Update - Possible risk of
vasculitis with dabigatran (Pradaxa)
Potential interaction between fluoxetine and levothyroxine
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Avanza | mirtazapine | tablet |
| Posaconazole | posaconazole | oral suspension |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Betaloc CR | metoprolol | tablet |
| Brilinta | ticagrelor | tablet |
| Carafate | sucralfate | tablet |
| Cialis | tadalafil | tablet |
| Cilicaine VK | phenoxymethylpenicillin | capsule |
| Crestor | rosuvastatin | tablet |
| Gonal-f | follitropin | injection |
| Imbruvica | ibrutinib | capsule, tablet |
| Kisqali | ribociclib | tablet |
| Luveris | luteinising hormone, human | injection |
| Neurontin | gabapentin | capsule, tablet |
| Otezla | apremilast | tablet |
| Paclitaxel Ebewe | paclitaxel | injection |
| Renvela | sevelamer | tablet, oral suspension |
| Saxenda | liraglutide | injection |
| Sinemet | carbidopa; levodopa | tablet |
| Synthroid | levothyroxine | tablet |
| Tecfidera | dimethyl fumarate | capsule |
| Zetlam | lamivudine | tablet |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Avanza | mirtazapine | tablet |
| Diclofenac Devatis | diclofenac | eye drops |
| Oxycodone Hydrochloride (Hameln) | oxycodone | injection |
| Posaconazole | posaconazole | oral suspension |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Abraxane | paclitaxel | injection |
| Arava | leflunomide | tablet |
| Betaloc CR | metoprolol | tablet |
| Brilinta | ticagrelor | tablet |
| Carafate | sucralfate | tablet |
| Cardizem | diltiazem | capsule |
| Cardizem CD | diltiazem | tablet |
| Cetrotide | cetrorelix | injection |
| Cialis | tadalafil | tablet |
| Cilicaine VK | phenoxymethylpenicillin | capsule |
| Crestor | rosuvastatin | tablet |
| Crinone | progesterone | gel |
| Curam | amoxicillin; clavulanic acid | oral suspension |
| DBL™ Cytarabine | cytarabine | injection |
| DBL™ Gemcitabine | gemcitabine | powder for injection |
| DBL™ Gemcitabine | gemcitabine | solution for injection |
| DBL™ Sulfamethoxazole and Trimethoprin | sulfamethoxazole; trimethoprim | injection |
| Diprivan | propofol | injection |
| Dukoral | cholera vaccine | oral suspension |
| Duodopa | carbidopa; levodopa | gel |
| Evista | raloxifene | tablet |
| Fasenra | benralizumab | injection |
| Ferriprox | deferiprone | tablet |
| Fragmin | dalteparin sodium | injection |
| Glypressin | terlipressin | injection |
| Gonal-f | follitropin | injection |
| Hemlibra | emicizumab | injection |
| Hydroxycarbamide | hydroxycarbamide | capsule |
| Imbruvica | ibrutinib | capsule, tablet |
| Lamictal | lamotrigine | tablet |
| Luveris | luteinising hormone, human | injection |
| Maviret | glecaprevir; pibrentasvir | tablet |
| Metoprolol | metoprolol | injection |
| Mobic | meloxicam | tablet |
| Otezla | apremilast | tablet |
| Ovidrel | chorionic gonadotrophin | injection |
| Paclitaxel Ebewe | paclitaxel | injection |
| Promozio | atovaquone; proguanil | tablet |
| Renvela | sevelamer | tablet, oral suspension |
| Sativex | cannabidiol; tetrahydrocannabinol | oral spray |
| Sinemet | carbidopa; levodopa | tablet |
| Stamaril | yellow fever vaccine | injection |
| Synthroid | levothyroxine | tablet |
| Tecfidera | dimethyl fumarate | capsule |
| Zetlam | lamivudine | tablet |
Additions to the Medsafe Website from 28 April-8 May 2020
COMMITTEES
Medicines Adverse Reactions Committee
Minutes of the 181st
Medicines Adverse Reactions Committee meeting
MEDICINES
Policy Statements
COVID-19 - Potential shortage of fentanyl injection – use of
unapproved product
SAFETY
Dear Healthcare Professional Letter
Use of
Hydroxychloroquine [Plaquenil] in the context of COVID 19 - Risk of
QT prolongation and drug/drug interactions ((PDF, 4 pages, 358 KB)
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Brintellix | vortioxetine hydrobromide | tablet |
| Ephedrine Hydrochloride (Wockhardt) | ephedrine hydrochloride | injection |
| Nitisinone (DiPharma) | nitisinone | capsule |
| Toujeo | neutral insulin | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Aimovig | erenumab | injection |
| Arava | leflunomide | tablet |
| Atacand | candesartan | tablet |
| Bricanyl | terbutaline | turbuhaler |
| Elaprase | idursulfase | infusion |
| Ferinject | ferric carboxymaltose | injection |
| Flucil | flucloxacillin | injection |
| Gardasil 9 | human papillomavirus vaccine | injection |
| Genvoya | cobicistat; elvitegravir; emtricitabine; tenofovir | tablet |
| Imfinzi | durvalumab | infusion |
| Keytruda | pembrolizumab | infusion |
| Lemtrada | alemtuzumab | infusion |
| Lynparza | olaparib | tablet |
| Metoclopramide (Pfizer) | metoclopramide | injection |
| Mupider | mupirocin | topical ointment |
| Ocrevus | ocrelizumab | infusion |
| Parnate | tranylcypromine | tablet |
| Ritalin | methylphenidate | tablet, capsule |
| Varivax | varicella vaccine | injection |
| Vesanoid | tretinoin | capsule |
| VFEND | voriconazole | tablet, oral supsension |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Brintellix | vortioxetine hydrobromide | tablet |
| Ephedrine Hydrochloride (Wockhardt) | ephedrine hydrochloride | injection |
| Nitisinone (DiPharma) | nitisinone | capsule |
| Toujeo | neutral insulin | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Aimovig | erenumab | injection |
| Atacand | candesartan | tablet |
| Atgam | antithymocyte immunoglobulin | injection |
| Bricanyl | terbutaline | turbuhaler |
| Cefazolin-AFT | cefazolin | injection |
| DBL™ Methotrexate | methotrexate | injection |
| Depo -Provera | medroxyprogesterone | Injection (depot) |
| DHC Continus | dihydrocodeine | tablet |
| Differin | adapalene | cream |
| Differin | adapalene | gel |
| Diflucan | fluconazole | capsule, oral suspension, infusion |
| Ferinject | ferric carboxymaltose | injection |
| Ferriprox | deferiprone | oral solution |
| Flucil | flucloxacillin | injection |
| Gardasil 9 | human papillomavirus vaccine | injection |
| Genvoya | cobicistat; elvitegravir; emtricitabine; tenofovir | tablet |
| Ilomedin | iloprost | infusion |
| Imfinzi | durvalumab | infusion |
| Iressa | gefitinib | tablet |
| Keytruda | pembrolizumab | infusion |
| Kisqali | ribociclib | tablet |
| Lemtrada | alemtuzumab | infusion |
| Lidocaine-Baxter | lidocaine | injection |
| Lynparza | olaparib | tablet |
| Marevan | warfarin | tablet |
| Metoclopramide (Pfizer) | metoclopramide | injection |
| Mupider | mupirocin | topical ointment |
| Nozinan | levomepromazine | injection |
| Nozinan | levomepromazine | tablet |
| Nozinan (Swiss stock ) | levomepromazine | tablet |
| Ocrevus | ocrelizumab | infusion |
| Opdivo | nivolumab | infusion |
| Provera | medroxyprogesterone | tablet |
| Ritalin | methylphenidate | tablet, capsule |
| Strattera | atomoxetine | capsule |
| Timoptol -XE | timolol | eye drops |
| Topamax | topiramate | tablet, capsule |
| Varivax | varicella vaccine | injection |
| Venofer | iron sucrose | injection |
| Vesanoid | tretinoin | capsule |
| VFEND | voriconazole | tablet, injection, oral supsension |
Additions to the Medsafe Website from 21-27 April 2020
MEDICINES
Policy Documents
COVID-19 - point of care test kits - restriction on importation,
manufacture, supply and use
SAFETY
Dear Investigator Letter
Supply of Typhim Vi under labelling exemption
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Creon Micro | pancreatin | granules |
| Tapclob | clobazam | oral suspension |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Carafate | sucralfate | tablet |
| Darzalex | daratumumab | infusion |
| Dortimopt | dorzolamide; timolol | eye drops |
| Dynastat | parecoxib | injection |
| Flixonase Allergy & Hayfever 24 Hour Spray | fluticasone | nasal spray suspension |
| Fosamax Once Weekly | alendronic acid | tablet |
| Fotivda | tivozanib | capsule |
| Frisium | clobazam | tablet |
| Gastrografin | amidotrizoic acid | oral solution |
| Inlyta | axitinib | tablet |
| Isoptin | verapamil | injection |
| Isoptin and Isoptin SR | verapamil | tablet |
| Keytruda | pembrolizumab | infusion |
| Levlen ED | ethinylestradiol; levonorgestrel | tablet |
| Neupogen | filgrastim | injection |
| Opdivo | nivolumab | infusion |
| Perjeta | pertuzumab | infusion |
| Praluent | alirocumab | injection |
| Tecfidera | dimethyl fumarate | capsule |
| Urografin | amidotrizoic acid | infusion |
| Yasmin | drospirenone; ethinylestradiol | tablet |
| Zypine ODT | olanzapine | wafer |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Creon Micro | pancreatin | granules |
| Dexamethasone Phosphate Panpharma | dexamethasone | injection |
| Tapclob | clobazam | oral suspension |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Addaven | chromium trichloride; copper chloride; ferric chloride; manganese chloride; potassium iodide; sodium fluoride; sodium molybdate; sodium selenite; zinc chloride | infusion |
| Amiodarone Hydrochloride Hameln | amiodarone | injection |
| Avonex Pen | interferon beta | injection |
| Besponsa | inotuzumab ozogamicin | injection |
| Carafate | sucralfate | tablet |
| Darzalex | daratumumab | infusion |
| DBL® Leucovorin Calcium | folinic acid | injection |
| DBL™ Irinotecan | irinotecan | injection |
| Dortimopt | dorzolamide; timolol | eye drops |
| Dynastat | parecoxib | injection |
| Erlyand | apalutamide | tablet |
| Fampyra | fampridine | tablet |
| Flixonase Allergy & Hayfever 24 Hour Spray | fluticasone | nasal spray suspension |
| Fluconazole-Baxter | fluconazole | infusion |
| Fosamax Once Weekly | alendronic acid | tablet |
| Fotivda | tivozanib | capsule |
| Frisium | clobazam | tablet |
| Herceptin | trastuzumab | infusion |
| Herceptin SC | trastuzumab | injection |
| Ilomedin | iloprost | infusion |
| Inlyta | axitinib | tablet |
| Isoptin | verapamil | injection |
| Isoptin and Isoptin SR | verapamil | tablet |
| Keytruda | pembrolizumab | infusion |
| Medrol | methylprednisolone | tablet |
| Nardil | phenelzine | tablet |
| Neupogen | filgrastim | injection |
| Ondansetron Kabi | ondansetron | injection |
| Opdivo | nivolumab | infusion |
| Paracetamol Kabi | paracetamol | injection |
| Plegridy | peginterferon beta-1a | injection |
| Praluent | alirocumab | injection |
| Pregabalin Pfizer | pregabalin | capsule |
| Replagal | agalsidase alfa | infusion |
| Reyataz | atazanavir | capsule |
| Solu-Medrol | methylprednisolone | injection |
| Spinraza | nusinersen | injection |
| Tecfidera | dimethyl fumarate | capsule |
| Voriconazole Max Healthcare | voriconazole | infusion |
| Voriconazole Generic Partners | voriconazole | tablet |
| Voriconazole Neo Health | voriconazole | injection |
| Zyban | bupropion | tablet |
| Zypine ODT | olanzapine | wafer |
Additions to the Medsafe Website from 14-20 April 2020
| CONSUMER MEDICINE INFORMATION | ||
|---|---|---|
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Fasenra | Benralizumab | injection |
| Pemetrexed Accord | Pemetrexed | infusion |
| Rekovelle | Follitropin delta | Injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Agrylin | Anagrelide | capsule |
| Apo-Mirtazapine | Mirtazapine | tablet |
| Arimidex | Anastrozole | tablet |
| Aubagio | Teriflunomide | tablet |
| Cipramil | Citalopram | tablet |
| Diamide | Loperamide | capsule |
| Diamide Relief | Loperamide | capsule |
| Genotropin | Somatropin | injection |
| Herceptin | Trastuzumab | infusion |
| Herceptin SC | Trastuzumab | injection |
| Influvac Tetra | Influenza vaccine polyvalent | Injection |
| Largactil | Chlorpromazine | injection, tablet |
| Lexapro | Escitalopram | tablet |
| Lioresal Intrathecal | Baclofen | solution |
| Loniten | Minoxidil | tablet |
| Lopresor | Metoprolol | tablet |
| Slow Lopresor | Metoprolol | tablet |
| Mersyndol | Codeine; Paracetamol | caplets, tablet |
| Nimenrix | Meningococcal vaccine | injection |
| Patanol | Olopatadine | eye drops |
| Sativex | Cannabidiol; Tetrahydrocannabinol | oral spray |
| Soframycin | Framycetin | ear/eye drops |
| Spiolto Respimat | Olodaterol; Tiotropium | solution for inhalation |
| Tagrisso | Osimertinib | tablet |
| Tecentriq | Atezolizumab | Infusion |
| Tramal | Tramadol | capsule, injection |
| Tramal SR | Tramadol | tablet |
| Yervoy | Ipilimumab | injection |
| DATA SHEETS | ||
| New | ||
| Tradename | Active ingredient(s) | Dose form |
| Chlorhexidine Acetate | Chlorhexidine | antiseptic solution |
| Fasenra | Benralizumab | injection |
| Pemetrexed Accord | Pemetrexed | infusion |
| Rekovelle | Follitropin delta | injection |
| Spazmol | Hyoscine | injection |
| Updated | ||
| Tradename | Active ingredient(s) | Dose form |
| Arimidex | Anastrozole | tablet |
| Aubagio | Teriflunomide | tablet |
| Carboplatin | Carboplatin | Injection |
| Cipramil | Citalopram | tablet |
| Clopidogrel Multichem | Clopidogrel | tablet |
| Dapsone (Link) | Dapsone | tablet |
| Carboplatin (DBL) | Carboplatin | Injection |
| Cisplatin (DBL) | Cisplatin | Injection |
| Sulfamethoxazole and Trimethoprim (DBLTM) | Sulfamethoxazole; Trimethoprim | Injection |
| Diamide | Loperamide | capsule |
| Diamide Relief | Loperamide | capsule |
| Dysport | Botulinum toxin type A | injection |
| Emtricitabine/Tenofovir disoproxil (Teva) | Emtricitabine; Tenofovir | tablet |
| Humulin | Neutral insulin | Injection |
| Influvac Tetra | Influenza vaccine polyvalent | Injection |
| Kyprolis | Carfilzomib | infusion |
| Largactil | Chlorpromazine | injection, tablet |
| Lexapro | Escitalopram | tablet |
| Lioresal Intrathecal | Baclofen | solution |
| Lopresor | Metoprolol | tablet |
| Slow Lopresor | Metoprolol | tablet |
| Mersyndol | Codeine; Paracetamol | caplets, tablet |
| Neostigmine Methylsulfate (Hameln) | Neostigmine | injection |
| Nimenrix | Meningococcal vaccine | injection |
| Orencia | Abatacept | injection |
| Parnate | Tranylcypromine | tablet |
| Patanol | Olopatadine | eye drops |
| Penthrox | Methoxyflurane | volatile liquid for inhalation |
| Perjeta | Pertuzumab | injection |
| Sativex | Cannabidiol; Tetrahydrocannabinol | oral spray |
| Spiolto Respimat | Olodaterol; Tiotropium | solution for inhalation |
| Tagrisso | Osimertinib | tablet |
| Tramal | Tramadol | capsule, injection |
| Tramal SR | Tramadol | Tablet |
| Yervoy | Ipilimumab | injection |
