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Additions to Medsafe's Web site from 1- 5 March 2010
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Intanza
Revised - Kaletra, Neupogen
Updated (name change only) - Cephalexin-ABM, Hydroxocobalamin-ABM,
Lariam, Madopar, Neorecormon, Neulastim, Nifuran, Pegasys, Pegasys RBV
Combination, Priadel, Pulmozyme inhalation solution
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Apo-Megestrol, Galantyl, Intanza,
Revised - Apo-Ascorbic, Arrow-Simva, Kaletra, Xeloda
Updated (name change only) - Cephalexin-ABM, D-Penamine, Daclin,
Diamide, Diurin 40, Diurin 500, Hydroxocobalamin-ABM, Lariam, Madopar, Metchek,
Neorecormon, Neupogen, Nifuran, Omezol, Pantocid IV, Pegasys, Pegasys RBV,
Priadel, Priligy, Pulmozyme
REGULATORY INFORMATION
Consultant
http://www.medsafe.govt.nz/regulatory/consultants.asp
This list has been updated
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 4 March 2010 has been added
Guidelines and Codes
http://www.medsafe.govt.nz/regulatory/Guideline/PriorityAndAbbreviatedAssessments.asp
Medsafe's Evaluation Policy for Priority and Abbreviated Assessments
Additions to Medsafe's Web site from 22-28 February 2010
HOT TOPICS
http://www.medsafe.govt.nz/hot/Consultation/Clozapine.asp
Request for comments on the proposal to widen prescriber access to clozapine.
The closing date for submissions is 26 March 2010
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Lumigan RC, Melorex
Updated - Aratac
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Lumigan RC
Updated - Azol, Cardinol-LA, Celapram, Celol, Cipflox, Clopress, Hybloc,
Mabthera, Priorix, Suprefact, Tenoxicam, Xenical
Medicine Supply Issues
http://www.medsafe.govt.nz/profs/supply.asp
This medicine has been added - Indocid PDA
REGULATORY INFORMATION
Consultant
http://www.medsafe.govt.nz/regulatory/consultants.asp
This list has been updated
Guidelines and Codes
New Zealand Regulatory Guidelines for Medicines - http://www.medsafe.govt.nz/regulatory/Guideline/Part%20D%20-%20NZ%20Regulatory%20Guidelines%20for%20Medicines.doc
Update to Volume 1, Part D, Section 4.10 as a result of the last Medicines
Classification Committee meeting held on 3 November 2009
Additions to Medsafe's Web site from 15-19 February 2010
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
Updated - 3TC, Acebutolol Hydrochloride, Adefin XL, Alanase 100,
Alanase 50, Alkeran, Amitrip, Amizide, Anten, Antinaus, Aratac, Aropax, Arrow-Sumatriptan,
Arthrexin, Atenolol, Augmentin and Augmentin powder for oral suspension,
Augmentin powder for injection, Augmentin tablet, AugmentinSyr, A-Zol,
Bactroban, Boostrix, Boostrix-IPV, Butacort 100, Butacort 50, Cardinol,
Combivir, Cosopt, Engerix-B, Eumovate, Flixonase, Flixotide Accuhaler,
Flixotide CFC-Free Inhaler, Fortum, Gopten, Havrix, Hepatyrix, Imigran
solution for injection, Imigran tablet, Infanrix, Infanrix-Hib, Infanrix-IPV,
Influvac, Isentress, Kapanol, Kemadrin, Kivexa, Konakion, Lamictal, Lanvis,
Leukeran, Lipex, Lyrica, Malarone, Marevan, Mencevax ACWY, Mivacron, Myleran,
Naramig, Neo-Naclex, Promethazine Winthrop, Puri-nethol, Relenza, Reminyl,
Requip, Retrovir, Rotarix, Seretide, Serevent (CFC Free), Serevent Accuhaler,
Stocrin, Synflorix, Synthroid, Timentin, Trandate, Trusopt, Twinrix, Tykerb,
Typherix, Ultiva, Varilrix, Zantac solution, Zantac syrup, Zeffix solution,
Ziagen, Zinacef, Zinnat, Zofran solution for injection, Zofran tablet, Zofran
Zydis, Zovirax
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp
New - Myaccord, Promethazine Winthrop
Updated - Acebutolol, Adefin XL, Alanase Aqueous, Amitrip, Amizide,
Anten, Antinaus, Aratac, Arthrexin, Atenolol, Beta Scalp Application, Butacort,
Cardinol, Cosopt, Gopten, Influvac, Isentress, Konakion and Konakion MM and
Konakion MM paediatric, Lipex, Lyrica, Marcain and Marcain with Adrenaline,
Maxipime, Neoral, Reductil, Reminyl, Sprycel, Stocrin, Synflorix, Taxotere,
Trusopt, Verpamil SR
REGULATORY INFORMATION
Consultants
http://www.medsafe.govt.nz/regulatory/consultants.asp
This list has been updated
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 4 February 2010 has been added
Additions to Medsafe's Web site from 8 - 12 February 2010
HOT TOPICS
Consultation Documents
http://www.medsafe.govt.nz/hot/Consultation/contents.asp
Request for comments on proposed updates to the New Zealand Good Clinical
Research Practice Guideline
The consultation of the proposed draft of the New Zealand Good Clinical
Research Practice Guideline is now closed and submissions are being evaluated.
Please disregard the proposed implementation date of 1 January 2010 stated in
the proposed draft updated Guideline. Medsafe will advise the implementation
date for the finalised Guidelines in due course.
Papers / Reports
Release of information relating to the approval process for the
Meningococcal B vaccine (MeNZB) application
Minutes of expert committee meetings added
- 25 June
2007
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/VSCMinutes25Jun2007.pdf - 11
September 2007
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/VSCMinutes11Sep2007.pdf
Timeline of actions during the approval process for the meningococcal B vaccine (MeNZB) application.
The following documents have been added
28 March, 19 April 2006
- Clinical
assessor's report on MeNZB (N. meningitidis group B, strain NZ98/254, outer
membrane vesicle vaccine)
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/EvaluatorsReportB.pdf - Full consent
application for the Meningococcal GroupB OMV vaccine MeNZB® by Chiron
Vaccines at the Rosia and Siena sites, Italy. Application in accordance with
Medicines Act 1981 and Medicines Regulations 1984, for consent to distribute
in New Zealand
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/EvaluatorsReportA.pdf
1 February 2007
- Poisson
Regression Modelling of the Effectiveness of the MeNZB Vaccine
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/PoissonRegressionVUW.pdf - An update of
the adverse reactions report prepared for the Centre for Adverse Reactions
Monitoring and the Meningococcal Vaccine Strategy Data Management Group
http://www.medsafe.govt.nz/hot/PapersReports/MeNZB/CARMandMVSDMGroup.pdf
INFORMATION FOR CONSUMERS
Consumer Medicine Information
http://www.medsafe.govt.nz/Consumers/cmi/CMIForm.asp
New - Celvapan
Updated - Accupril, Accuretic, Aricept, Caverject, Celebrex, Cubicin,
Diflucan capsules and solution, Diflucan injection, Dilantin, Dynastat,
Fosamax Plus, Fragmin, Genotropin, Haldol, Lipitor, Lyrica, Neurontin,
Propecia, Proscar, Risperdal Consta, Ritalin LA, Salazopyrin, Vfend, Viagra,
Xanax, Zarontin, Zavedos capsules, Zavedos injection, Zithromax, Zoloft, Zyvox
solution for infusion, Zyvox tablet
INFORMATION FOR HEALTH PROFESSIONALS
Classification of Medicines
The following documents have been added
- Agenda for the 43rd Medicines
Classification Committee meeting
http://www.medsafe.govt.nz/profs/class/agen43.htm
The following documents have been updated
- Dates and Deadlines have been updated
http://www.medsafe.govt.nz/profs/class/dates.asp - Minutes of the November
2009 Medicines Classification Committee meeting - update on the
classification of codeine
http://www.medsafe.govt.nz/profs/class/mccMin03Nov2009.htm - Recent NZ Gazette
Notices Relating to Classification, 11 February 2010
http://www.medsafe.govt.nz/profs/class/recent.asp#11%20February%202010
INFORMATION FOR HEALTH PROFESSIONALS
Datasheets
New - ReTrieve, Ritalin and Ritalin LA and Ritalin SR
Updated - Accupril, Accuretic, Aricept, Caverject, Celebrex, Clozaril,
Cubicin, Curosurf, Dexamethasone, Diflucan capsule, powder for oral suspension
and intravenous infusion, Dilantin, Dynastat, Fosamax Plus, Fragmin,
Genotropin, Lyrica, Neurontin, Propecia, Proscar, Risperdal Consta old,
Risperdal Consta new, Salazopyrin, Sandimmun, Vaxigrip, Vfend, Viagra,
Voltaren Ophtha eye drops, Xanax, Zarontin, Zavedos, Zevalin, Zithromax,
Zoloft, Zyvox,
REGULATORY INFORMATION
Gazette Notices
http://www.medsafe.govt.nz/Regulatory/gazette.asp
Gazette Notice for 11 February 2010 has been added