About Medsafe

Revised: 19 June 2018

What's New

Additions to the Medsafe Website from 28 May-18 June 2018


ABOUT MEDSAFE

Vacancy
Advisor Science (GMP Audit)
 
COMMITTEES
Medicines Assessment Advisory Committee
Summary of recommendations from the 106th Medicines Assessment Advisory Committee meeting – 27 March 2018
 
Medicines Classification Committee
Medicines Classification Committee - Dates and Deadlines have been updated
Minutes of the 60th meeting of the Medicines Classification Committee - 26 April 2018
 
MEDICAL DEVICES
Quality Issues and Adverse Event Reporting
These reports have been updated
Quality incident report (Microsoft Word document 75 KB, 3 pages)
Adverse Event Report (Healthcare Professionals) (Microsoft Word document 82 KB, 2 pages)
 
MEDICINES
Policy Statements
What to do in the case of a potential out of stock
 
PUBLICATIONS
Prescriber Update
Prescriber Update June 2018 Vol. 39 No. 2

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Doxazosin doxazosin Tablet
Updated
Tradename Active ingredient(s) Dose form
Cozaar losartan tablet
Cystadane betaine oral solution
Duotrav timolol; travoprost eye drops
Entecavir Sandoz entecavir tablet
Flucon fluorometholone eye drops solution
HyperHep B hepatitis b immunoglobulin (human) injection
Hyzaar hydrochlorothiazide; losartan tablet
Lanzol Relief lansoprazole capsule
Lipex simvastatin tablet
Lynparza olaparib capsule
Noriday norethisterone tablet
Norvasc amlodipine besilate tablet
Renitec and Renitec M enalapril tablet
Rotarix rotavirus vaccine oral suspension
Triumeq abacavir; dolutegravir; lamivudine tablet
Veletri epoprostenol infusion
Visudyne verteporfin infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Dobutamine-Hameln dobutamine infusion
Updated
Tradename Active ingredient(s) Dose form
Apo-Doxazosin doxazosin tablet
BCG Vaccine BCG injection
Buccastem prochlorperazine buccal tablet
Cozaar losartan tablet
Cystadane betaine oral solution
Darzalex daratumumab infusion
Dilantin phenytoin sodium capsule
tablet
oral solution
Entecavir Sandoz entecavir tablet
Epilim valproic acid tablet
injection
oral solution
syrup
Flucon fluorometholone eye drops solution
Herceptin trastuzumab injection
Herceptin trastuzumab infusion
HyperHep B hepatitis b immunoglobulin (human) injection
Hyzaar hydrochlorothiazide; losartan tablet
Intelence etravirine tablet
Invega paliperidone tablet
Invega Sustenna paliperidone suspension
Invega Trinza paliperidone suspension
Kadcyla trastuzumab emtansine infusion
Lanzol Relief lansoprazole capsule
Lipex simvastatin tablet
Mestane exemestane tablet
Microgynon 30 ED ethinylestradiol; levonorgestrel tablet
Minims Prednisolone prednisolone eye drops
Naphcon Forte naphazoline hydrochloride eye drops
Renitec and
Renitec M
enalapril tablet
Replagal agalsidase alfa infusion
Ringers calcium chloride; potassium chloride; sodium chloride infusion
Risperdal risperidone tablet
oral solution
Risperdal Consta risperidone suspension
Rotarix rotavirus vaccine oral suspension
Symbicort budesonide; formoterol turbuhaler
Tamiflu oseltamivir oral suspension
Topamax and
Topamax Sprinkles
topiramate tablet
capsule
Triumeq abacavir; dolutegravir; lamivudine tablet
Tysabri natalizumab infusion
Vannair budesonide; formoterol inhaler
Veletri epoprostenol infusion
Visudyne verteporfin infusion
Vit.D3 colecalciferol capsule
Xalkori crizotinib capsule
Zinforo ceftaroline fosamil injection


Additions to the Medsafe Website from 7-25 May 2018


CONSULTATIONS
Review of fees payable under the Medicines Regulations 1984 - Outcome of Consultation

SAFETY
Monitoring Communication
Life-threatening severe allergic (anaphylaxis) to Calocurb dietary supplement

CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Apo-Oxybutynin oxybutynin tablet
syrup
Updated
Tradename Active ingredient(s) Dose form
Cubicin daptomycin infusion
Dulcolax bisacodyl tablet
suppositories
Eprex erythropoietin injection
Forxiga dapagliflozin tablet
Humira adalimumab injection
Janumet metformin hydrochloride tablet
Januvia sitagliptin tablet
Kinson carbidopa; levodopa tablet
Loxalate escitalopram tablet
Norflex orphenadrine tablet
Norpress nortriptyline tablet
NuvaRing etonogestrel; ethinylestradiol vaginal ring
Razene cetirizine tablet
Seroquel quetiapine tablet
Tivicay dolutegravir tablet
Tobradex tobramycin; dexamethasone eye drops
eye ointment
Ultibro Breezhaler glycopyrronium bromide; indacaterol inhalation capsule
Vaclovir valaciclovir tablet
Varivax varicella vaccine injection
Zetlam lamivudine tablet
Zometa zoledronic acid infusion
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Doxylin doxycycline tablet
Hexvix hexaminolevulinate injection
Ionolyte isotonic solution of electrolytes infusion
Updated
Tradename Active ingredient(s) Dose form
3TC lamivudine oral solution
Calcium Resonium calcium polystyrene sulfonate oral solution
Cubicin daptomycin infusion
DBL Zoledronic Acid zoledronic acid infusion
Descovy emtricitabine; tenofovir tablet
Duac Once Daily benzoyl peroxide; clindamycin gel
Exemestane Pfizer exemestane tablet
Imovane zopiclone tablet
Janumet metformin hydrochloride tablet
Januvia sitagliptin tablet
Kinson carbidopa; levodopa tablet
Loxalate escitalopram tablet
Lynparza olaparib capsule
Norflex orphenadrine tablet
Norpress nortriptyline tablet
Nurofen Plus codeine; ibuprofen tablet
NuvaRing etonogestrel; ethinylestradiol vaginal ring
PeriOlimel and Olimel glucose solution; lipid emulsion; amino acid solution (with/without electrolytes) infusion
Perjeta infusion
Pharmorubicin epirubicin injection
Precedex dexmedetomidine infusion
Razene cetirizine tablet
Resonium-A sodium polystyrene sulfonate oral solution
Retrovir zidovudine capsule
oral solution
injection
Stelara ustekinumab injection
infusion
Tivicay dolutegravir tablet
Tobradex tobramycin; dexamethasone eye drops
eye ointment
Ultibro Breezhaler glycopyrronium bromide; indacaterol inhalation capsule
Vaclovir valaciclovir tablet
Vermox mebendazole tablet
suspension
Zetlam lamivudine tablet
Zometa zoledronic acid infusion

Additions to the Medsafe Website from 1-7 May 2018


COMPLIANCE
GMP Certified Contract Testing Laboratories

SAFETY
Monitoring Communication
Beware turmeric/curcumin containing products can interact with warfarin

CONSUMER MEDICINE INFORMATION
Updated
Tradename Active ingredient(s) Dose form
Azol danazol capsule
Celapram citalopram tablet
Epclusa sofosbuvir; velpatasvir tablet
Humira adalimumab injection
pen injection
Klacid clarithromycin oral suspension
injection
Levlen ED ethinylestradiol; levonorgestrel tablet
Logem lamotrigine tablet
Mersyndol codeine; doxylamine; paracetamol tablet
Microgynon 50 ED ethinylestradiol; levonorgestrel tablet
Miostat carbachol injection
Mirena levonorgestrel intrauterine contraceptive device
Mydriacyl tropicamide eye drops
Qlaira dienogest; estradiol tablet
Rifadin rifampicin capsule
tablet
oral suspension
injection
Tasmar tolcapone tablet
Volibris ambrisentan tablet
Zypine olanzapine tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Colpocin-T metronidazole infusion
Ibuprofen (Ethics) ibuprofen oral suspension
Updated
Tradename Active ingredient(s) Dose form
Azol danazol capsule
Celapram citalopram tablet
Entecavir (Generic Partners) entecavir tablet
Entecavir (Juno) entecavir tablet
Epclusa sofosbuvir; velpatasvir tablet
Humira adalimumab injection
pen injection
Imbruvica ibrutinib capsule
Levlen ED ethinylestradiol; levonorgestrel tablet
Logem lamotrigine tablet
Mersyndol codeine; doxylamine; paracetamol tablet
Methoblastin methotrexate tablet
Microgynon 20 ED ethinylestradiol; levonorgestrel tablet
Microgynon 50 ED ethinylestradiol; levonorgestrel tablet
Miostat carbachol injection
Mydriacyl tropicamide eye drops
Naloxone Hydrochloride (Hameln) naloxone injection
Oratane isotretinoin capsule
pms-Bosentan bosentan tablet
Qlaira dienogest; estradiol tablet
Varivax varicella vaccine injection
Volibris ambrisentan tablet
Zypine olanzapine tablet
 

Additions to the Medsafe Website from 23-30 April 2018

 
COMPLIANCE
GMP Certified Contract Testing Laboratories

SAFETY
Monitoring Communication
Beware turmeric/curcumin containing products can interact with warfarin  
CONSUMER MEDICINE INFORMATION
New
Tradename Active ingredient(s) Dose form
Ciprofloxacin (Teva) ciprofloxacin eye drops
Dymista azelastine; fluticasone nasal spray
Oxytocin APOTEX oxytocin injection
Updated
Tradename Active ingredient(s) Dose form
Alcaine proxymetacaine hydrochloride eye drops
Clozaril clozapine tablet
Cyclogyl cyclopenlate hydrochloride eye drops
Estelle-35 and Estelle-35 ED cyproterone; ethinylestradiol tablet
Fluorescite fluorescein injection
FML fluorometholone eye drops
Mydriacyl tropicamide eye drops
Onbrez Breezehaler indacaterol capsule
Opsumit macitentan tablet
DATA SHEETS
New
Tradename Active ingredient(s) Dose form
Dymista azelastine; fluticasone nasal spray
Updated
Tradename Active ingredient(s) Dose form
Alcaine proxymetacaine hydrochloride eye drops
Clozaril clozapine tablet
Cyclogyl cyclopenlate hydrochloride eye drops
Estelle-35 and Estelle-35 ED cyproterone; ethinylestradiol tablet
Fluorescite fluorescein injection
Klacid clarithromycin granules for oral suspension;
tablet
Mydriacyl tropicamide eye drops
Naphcon-A naphazoline hydrochloride; pheniramine maleate eye drops
Opsumit macitentan tablet
Oxytocin APOTEX oxytocin injection
Suboxone buprenorphine; naloxone tablet
Tagrisso osimertinib tablet