What's New
Latest
2 weeks ago
3 weeks ago
4 weeks ago
Additions to Medsafe's Web site from 15 March - 12 April 2013
HOT TOPICS
Consultation Documents
http://www.medsafe.govt.nz/hot/Consultation/OutcomeOTCMedicines.asp
Outcome of consultation on the proposed Over-the-Counter (OTC) Medicines
Business Process Reforms
Media Releases
http://www.medsafe.govt.nz/hot/media/HerbalSmokingMaterial.asp
Conviction
for sale of herbal smoking material containing a prescription medicine
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New -
Eylea injection solution, Picosalax powder for oral solution, Prolox tablet,
SmofKabiven electrolyte free emulsion for infusion, SmofKabiven emulsion for
infusion, Tranexamic Acid tablet
Updated - Alanase nasal spray
solution 100 ìg/dose, Alanase nasal spray solution 50 ìg/dose, Aratac
tablet, Aropax tablet, Ativan tablet, Bricanyl Turbuhaler, Butacort nasal
spray suspension 100 ìg/dose, Butacort nasal spray suspension 50 ìg/dose,
Capoten oral solution, Cipflox tablet, Clozaril tablet, Cyklokapron tablet
and solution for injection, Diurin tablet, Fluox capsule and tablet, Foradil
capsule, Fungilin lozenge, Glucobay tablet, Lostaar tablet, Loxamine tablet,
Normison tablet, Paxam tablet, Protos granules for oral suspension, Simulect
powder for injection, Singulair tablet, Tamiflu capsule, Temgesic injection
solution, Tranexamic Acid tablet, Xolair injection
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New -
Fluconazole capsule (IPCA), Pipetam injection powder, SmofKabiven
electrolyte free emulsion for infusion, SmofKabiven emulsion for infusion
Updated - Abilify tablet, Alanase nasal spray solution, Alphagan
eye drop, Apo-Perindopril tablet, Apo-Risperidone tablet, Aratac tablet,
Ativan tablet, Avonex injection and Avonex Pen, Beconase Allergy & Hayfever
12 Hour, Binocrit solution for injection, Butacort nasal spray suspension,
Capoten oral solution, Cipflox tablet and infusion, Clozaril tablet,
Co-Renitec tablet, DBL Leucovorin Calcium tablet and solution for injection,
Diane-35 ED tablet, Diurin tablet, Effient tablet, Erbitux solution for
infusion, Etopophos powder for injection, Eylea solution for injection,
Fluox capsule and tablet, Fluoxetine capsule (Ethics), Fluoxetine-AFT oral
liquid, Fungilin lozenge, Humira pen/solution for injection, HyperHEP B
solution for injection, Kenalog in Orabase oral paste, Lostaar tablet,
Loxamine tablet, Miochol E powder for injection, Modecate injection,
Neurontin tablet and capsule, Normison tablet, Paroxetine tablet, Paxam
tablet, Picosalax powder for oral solution, Protos granules for oral
suspension, Rapamune tablet and oral solution, Salazopyrin and
Salazopyrin-EN tablet, Stelara solution for injection, Sutent capsules,
Tamiflu capsule and oral suspension, Telnase nasal spray, Temgesic injection
solution, Tolvon tablet, Xolair solution for injection, Zometa solution for
infusion
Medicines Monitoring
http://www.medsafe.govt.nz/profs/M2MedicinesMonitoring.asp
Updated to
remove Ibuprofen as the active monitoring period had ended
PROJECTS
OTC Medicines Processes
http://www.medsafe.govt.nz/Projects/B5/OTCContents.asp
OTC Medicines:
guidelines and processes update 2013 – 25 March 2013
Over-the-counter
(OTC) medicines business reforms: Staged implementation plan - 25 March 2013
REGULATORY INFORMATION
Forms
http://www.medsafe.govt.nz/regulatory/forms.asp
Changed Medicine
Notification Form A (effective from April 2013)
New Medicine Application
- OTC Medicine Form (effective from April 2013)
New Medicine Application
- OTC Medicine Declarations and Commitments (effective from April 2013)
New Medicine Application - Prescription Medicine Form (effective from April
2013)
New Medicine Application - Prescription Medicine Declarations and
Commitments
New Related Product Application Form (effective from April
2013)
New Related Product Declarations and Commitments (effective from
April 2013)
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 21
March 2013 has been added
Guidelines and Codes
http://www.medsafe.govt.nz/regulatory/guidelines.asp
Part 2A:
Over-the-counter medicines: Pre-market application and evaluation process
Appendix 1: Application selection tools
Appendix 2: OTC medicines
changes tables
Additions to Medsafe's Web site from 11-15 March 2013
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
Updated - Lanoxin tablet and PG tablet and paediatric elixir, Lipex
tablet, Loxalate tablet, Requip tablet and starter packs and follow on packs,
Vytorin tablet
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Apo-Aripiprazole tablet, Genteal eye drops
Updated - Abraxane powder for injection, Amiodarone Hydrochloride
injection, Apo-Sertraline tablet, Aropax tablet, Avage topical cream, Celapram
tablet, Cyklokapron tablet and injection solution, Finasteride tablet, Inspra
tablet, Loxalate tablet, Noctamid tablet, Requip tablet and starter packs and
follow on packs, Zorac topical cream, Zorac topical gel, Zyprexa IM, Zyprexa
Relprevv injection, Zyprexa tablet
Prescriber Update Articles
http://www.medsafe.govt.nz/profs/PUarticles.asp
Prescriber Update March 2013 has been added
PROJECTS
OTC Medicines
Processes
http://www.medsafe.govt.nz/Projects/B5/OTC%20Medicines%20Processes.asp
Over-the-Counter (OTC) Medicines Business Process Reform: Outcome of
Consultation -15 March 2013 has been added
REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 14 March 2013 has been added
Additions to Medsafe's Web site from 4-8 March 2013
HOT TOPICS
Consultation
Documents
http://www.medsafe.govt.nz/hot/Consultation/B2B_B2EarlyWarningSystem.asp
Joint Medsafe and TGA project: Trans-Tasman Early Warning System of Safety
Concerns with Medicines and Medical Devices
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Adenuric tablet, Amoxil capsule, Docetaxel Sandoz concentrate for
infusion 20mg/2mL, Docetaxel Sandoz concentrate for infusion 80mg/8mL, Oxydone
BNM tablet
Updated - Celapram tablet, Clopixol tablet and Clopixol Depot and
Clopixol Acuphase, Cozaar tablet, Fluanxol Depot injection and concentrated
injection, Hyzaar tablet, Maxalt and Maxalt Melt wafer, Mercilon 28 tablet,
Risperdal Consta powder for injection, Risperdal tablet and oral solution and
quicklet, Tranexamic Acid tablet, Trileptal tablet, Vannair aerosol inhaler,
Yaz tablet
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Adenuric tablet, Aloxi solution for injection, Apo-Valgan tablet,
Docetaxel Sandoz concentrate for infusion 20mg/2mL, Docetaxel Sandoz
concentrate for infusion 80mg/8mL, Oxydone BNM tablet, PeriOlimel and Olimel
infusion, Prolox tablet
Updated - Amoxil capsule and syrup and paediatric drops, Apo-Paroxetine
tablet, Apo-Perindopril tablet, Arrow Roxithromycin tablet, Arrow-Citalopram
tablet, Arrow-Fluoxetine capsule, Arrow-Sertraline tablet, Arrow-Venlafaxine
XR tablet, Cilicaine solution for injection, Clopixol tablet and Clopixol
Depot and Clopixol Acuphase, Fluanxol Depot injection and concentrated
injection, Maxalt and Maxalt Melt wafer, Norvasc tablet, Noxafil oral
suspension, Paracetamol-AFT solution for infusion, Risperdal Consta powder for
injection, Risperdal tablet and oral solution and quicklet, Setrona tablet,
Tisseel Fibrin Sealant topical solution, Tranexamic Acid tablet, Trileptal
tablet and oral suspension
REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 7 March 2013 has been added
Additions to Medsafe's Web site from 25 February - 1 March 2013
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Victrelis Pegatron Combination Therapy
Updated - Kenacomb ear drops, Mirena intrauterine contraceptive device,
NuvaRing vaginal ring, Pegatron Combination Therapy, Peg-Intron Clearclick
injection with diluent, Polyvisc eye ointment, Stelazine tablet
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
Updated - Arrow – Amitriptyline tablet, Candestar tablet, Cialis
tablet, Evista tablet, Foradil capsule, Forteo solution for injection, Incivo
tablet, Inhibace Plus tablet, Lipex tablet, Mirena intrauterine contraceptive
device, Pegatron Combination Therapy, Peg-Intron Clearclick injection with
diluent, Prozac capsule, Vytorin tablet
REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 28 February 2013 has been added