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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