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Latest
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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