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Additions to Medsafe's Web site from 2-6 November 2009

INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Amirol, Curam, Ginet-63 and Ginet-84, Sebivo
Updated - Asacol, Flagyl and Flagyl-S, Glucobay, Metronidazole, Minomycin, Pharmorubicin, Prezista, Sprycel, Vaqta, Zavedos

REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 5 November 2009 has been added

Guidelines
http://www.medsafe.govt.nz/regulatory/Guideline/NZRGM%20Volume%201.asp
New Zealand Guidelines for Medicines, Volume 1
Part C, Section 2.4.1 - MHRA added as a recognised authority for the abbreivated process

Influenza Vaccine Formulation
http://www.medsafe.govt.nz/regulatory/flu.asp
The influenza vaccine composition for New Zealand in 2010 has been added.


Additions to Medsafe's Web site from 26-30 October 2009

INFORMATION FOR HEALTH PROFESSIONALS
Adverse Reaction Reporting and IMMP
Minutes of the 139th meeting of the Medicines Adverse Reactions Committee meeting held on 10 September 2009
http://www.medsafe.govt.nz/profs/adverse/Minutes139.htm

Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Atripla, Onkotrone, Sculptra
Updated - Indocid PDA, A-Lices Lotion, Antinaus, Apo-Amlodipine, Avastin, Celol, Cialis, Co-Renitec, Cozaar, Engerix-B, Fabrazyme, Hyzaar, Invanz, Lipex, Methadone injection BP, Rapamune, Renitec and Renitec M, Singulair, Strattera, Tegretol, Tredaptive, Vumon, Vytorin

REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 29 October 2009 has been added

Guidelines and Codes
New Zealand Guidelines for Medicines

Volume 1: Guidance notes for applicants for consent to distribute new and changed medicines and related products
Part E- Labelling Checklist for Medicines, Part F has been added to subsection 5.A
Volume 1

http://www.medsafe.govt.nz/regulatory/Guideline/NZRGM%20Volume%201.asp
Summary of Changes
http://www.medsafe.govt.nz/regulatory/Guideline/summaryofchanges.asp


Additions to Medsafe's Web site from 19-23 October 2009

INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Afinitor
Updated - Aclasta, Actemra, Actemra, Aropax, Avastin, EpiPen, EpiPen Junior, Estelle, Losec, Valcyte, Vaqta

INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Docetaxel Ebewe
Updated - Copegus, Dilzem, Dopress, EpiPen, EpiPen Junior, Hepsera, Intelence, Kogenate FS, Losec capsules and tablets, Losec IV, Pegasys, Pegasys RBV, Staphlex

REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp 
Gazette Notice for 22 October 2009 has been added


Additions to Medsafe's Web site from 12-16 October 2009

HOT TOPICS
Alerts/Letters
Use of Cough and Cold Medicines in Children - New advice
http://www.medsafe.govt.nz/hot/alerts/CoughandCold/InfoOct2009.asp
A list of the affected medicines has also been added http://www.medsafe.govt.nz/hot/alerts/CoughandCold/AffectedMedicinesOct2009.asp

Consultation Documents
Review of the submission and publication processes for data sheets and Consumer Medicine Information on the Medsafe website - Consultation closes on 20 November 2009
http://www.medsafe.govt.nz/hot/Consultation/DataSheetsAndCMI.asp
Request for comments on proposed updates to the New Zealand Good Clinical Research Practice Guideline - Consultation closes on 30 November 2009
http://www.medsafe.govt.nz/hot/Consultation/ClinicalTrials.asp

INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Apo-Risperidone, Feiba NF, Heparin Sodium (Pfizer), Heparinised Saline, Metformin
Updated - Aclasta, Aropax, Gadovist, Peditrace, Pravachol, Pyrazinamide-AFT, Vaqta, Zeldox IM, Zeldox tablets

REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 15 October 2009 has been added