Medsafe nz. Publications Prescriber Update.
Medsafe nz LYRICA poses risks of misuse, abuse and dependence About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #40 – 31 January 2022. Published 7 March 2024 Prescriber Update 45(1): 2–4 March 2024 Dietary Supplements. Medicines Gazette Notices. It has two offices in Wellington and Auckland, and employs 60 They considered that the current evidence for a causal link is weak and recommended that Medsafe publish a monitoring communication to gather more information. 4 mg . Medsafe advises people NOT to www. Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution. Dosing for asthma and CRSwNP follows the same dosing principles. 5 mg/mL concentrated suspension Losec CMI 010423 2(5) Losec works by decreasing the amount of acid made by the stomach, to give relief of symptoms and allow healing to take place. About Medsafe's Evaluation and Approval Process; Label Statements Database; Permitted Colourings; Forms and templates; Schedule of Fees; Unapproved Medicines; Gazette Notices; EFT Medsafe's copyright statement. As it is Atorvastatin10mg, 20mg, 40mg & 80mg film-coated tablets (Pharmacare®) 4 Drinking very large quantities (over . Medicines Medicine Information Approval Process Regulatory Guidance Clinical Trials Classification Manufacturing Revised: 5 December 2024. The MAAC will consider any COVID-19 vaccines referred to them under urgency. 7 Zinc - amendment to classification statements (Medsafe) Background. Methotrexate interferes with folic acid metabolism and folic acid tablets are used to How Medsafe keeps the safety of all vaccines approved for use in New Zealand under continual review. 2 litres) of grapefruit juice each day Published: 7 March 2019. It is a quinazoline derivative. Microbial limit testing of raw materials, including purified water, in Revised: 2 November 2022. nz. QUALITATIVE AND QUANTITATIVE Revised: 22 May 2019. nz) for the most recent datasheet Page 5 Long term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) Published: 1 June 2017. The MCC is asked to amend the classification statements for zinc. Further Information. New Zealand Medicines and Medical Devices Safety Authority. Key Messages. About Medsafe COVID-19 Archive Medicines to treat COVID-19 – Questions and Answers CONSUMER MEDICINE INFORMATION ARROW - AMITRIPTYLINE Amitriptyline hydrochloride 10 mg, 25 mg and 50 mg film -coated tablets What is in this leaflet When you report your suspected side effects to Medsafe and the Centre for Adverse Reactions Monitoring, you help us to detect, investigate and take action on safety Please refer to Medsafe website (www. It provides an overview of the access of unapproved medicinal cannabis products under the new Medicinal Cannabis Eurofins BioPharma Product Testing NZ Ltd: PO Box 12545 Penrose Auckland 1642: 35 O’Rorke Road, Penrose, Auckland. Information for Industry Guidelines and Codes. Gazette notices for medicine applications approved after 1 January 2022 are republished here. Use of zopiclone for longer than 4 weeks should be considered ‘off-label’. If BPAC NZ. 2. However, the maximum daily dose of folic acid may be Actemra 20241115 1 NEW ZEALAND DATA SHEET 1. nz Progestogen-only contraceptives Progestogen-only contraceptives contain only a progestogen — they do not contain any oestrogen. More Published: 27 November 2020 Revised: 6 June 2024 Archived: 21 August 2024. nz) for the most recent datasheet Page 1 of 15 Presentation Apo-Metoprolol 100 mg tablets are white. THIS PAGE IS NOW OUT OF DATE 5 Mechanism of Action Doxazosin is in a group of medicines called antihypertensive medicines. Publications Latest Issue of Prescriber Update. What is Medsafe? Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. More Medsafe's Evaluation and Approval Process; Label Statements Database; Permitted Colourings; Forms and templates; Schedule of Fees; Unapproved Medicines; Gazette Notices; EFT LYRICA – data sheet Page 1 of 22 NEW ZEALAND DATA SHEET LYRICA is a potential drug of misuse, abuse, and dependence. Prescriber Update provides information on For NMAs that have been granted priority assessment the applicant’s response must be received by Medsafe within 28 days to retain priority status. Medsafe uses a secure electronic file transfer system (EFT) to receive documents from companies. If you wish to copy or circulate information from SMARS, please ensure that a copy of these guidelines is provided. Recent safety communications issued by Medsafe. Further information about this scheme can be found in the Guideline on the Regulation Administration and Maintenance of Product Files. No. Use of SMARS data. Current Guidelines for the regulation of therapeutic products in New Zealand (GRTPNZ) Revised: 28 July 2016. The EFT is a secure system as the file is encrypted in transit and then stored on a Page 1 of 7 NEW ZEALAND DATA SHEET CREON® 10,000, CREON® 20,000 CREON® 25,000, CREON® 35,000 1. Safety Information Monitoring communication. About Medsafe COVID-19 Archive Vaccine Approval. Product Status Change Request Form (effective from November 2019) (Microsoft Word 21KB); Request for Removal of Manufacturing, Testing . Prescriber Update is written for healthcare professionals to provide information on safety concerns with medicines and medical devices. It exerts a vasodilator effect via selective and competitive blockade Refer to the Medsafe guidance in: Overview of therapeutic product regulation, available for download from the Guidelines on the Regulation of Therapeutic Products in New Zealand Medsafe has generated a register of Proprietary Ingredients to ensure accurate and up to date information is held on Proprietary Ingredients used in pharmaceutical products marketed in This article has been provided by the Ministry of Health. Medsafe is the government agency responsible for regulating medicines and medical devices in New Zealand. It is Medsafe has not assessed the safety and efficacy of longer-term use. The current prescription Medsafe's copyright statement. Where to get your medicine from Where to go for information about medicines Labels on medicines Published: 7 March 2024. clexane-clexane-forte-ccdsv14-dsv22-20jun22 Page 4 . Prior to any Medsafe administers an approval scheme for clinical trials under Section 30 of the Medicines Act 1981. Please email your Key Messages . Medical Devices Regulatory Requirements for Sponsors. More Recent information on safety concerns with medicines and medical Medsafe is the agency run by the New Zealand Ministry of Health that administers the Medicines Act and Medicines Regulations. Further information on the development of the Medicines Monitoring scheme and Medsafe's safety Medsafe can also refer COVID-19 vaccines to the MAAC for a final recommendation about approval. This article is more than five years old. This does not stop food being digested New Zealand Datasheet 1 PRODUCT NAME Tamsulosin capsules . This section describes how Medsafe regulates dietary supplements in New Zealand. The regulatory status of the medicinal product is detailed in the Registration Situation and has the following meanings: Summary information about all recall actions initiated in New Zealand from 1 July 2012. The reclassification will allow supply of approved low-dose CBD MEDSAFE. Flucloxacillin 500 mg capsules. Committees Medicines Assessment Advisory Committee. December 2020 Version: pfdcovii11123 Supersedes: pfdcovii11023 Page 1 of 25 NEW ZEALAND DATA SHEET 1. Medsafe advises people NOT to Medsafe has reclassified cannabidiol (CBD) from a prescription-only medicine to a restricted (pharmacist-only) medicine. Medicines Submitting applications electronically to Medsafe. Medicines and medical devices provide important benefits for consumers but no product is completely safe. Sponsors of medical devices are required to meet all of the requirements of the Medicines Act 1981, the Medsafe is reviewing whether pholcodine-containing medicines should continue to be available in New Zealand following withdrawal in other countries. Please refer to the New Zealand Gazette Home About Medsafe History of Medicines and medical device regulation in New Zealand COVID-19 Archive Safety Monitoring. The patient had a pre-existing 1 HYDROXOCOBALAMIN PANPHARMA Hydroxocobalamin acetate Solution for injection 1 mg/mL New Zealand Data Sheet 1 PRODUCT NAME HYDROXOCOBALAMIN PANPHARMA Published: 23 March 2020 Updated: 12 June 2023 Archived: 21 August 2024. Reporters should contact the Ministry of Health's Medsafe is working with other medicines regulators on both the approval process and safety monitoring. Publications Prescriber Update. Find out how to apply for pharmacy licences, bring medicines into the country, and deal with Information on reporting an adverse event or a quality issue associated with a medical device. Prescriber Update is a newsletter written for health care professionals. About Medsafe. 3 PHARMACEUTICAL FORM . Whilst many risks are identified before the product is used in New Zealand This section provides information useful to healthcare professionals. govt. 9 mL, solution for Revised: 10 May 2011. 1. What is in this leaflet CGRP have been Published: 3 December 2020. About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #45 – 31 August 2022. These are available as: • oral tablets NEW ZEALAND DATA SHEET . The Medicines Assessment Advisory Committee (MAAC) provides advice to the Minister of Health on the Dietary Supplements containing Folic Acid. Prior to any Notice of Medsafe Office Closure Christmas/New Year 2024/2025: 17/12/2024: Consultation: Proposal to change the regulatory and funding restrictions for stimulant treatments for ADHD: About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #44 – 30 June 2022. Publications Spotlight on rivaroxaban (Xarelto) Prescriber Update 40(1): 8–10 March 2019 Medsafe is working with other medicines regulators on both the approval process and safety monitoring. Medicines Registration Situation. Allows you to search for new Medicine Applications and Changed Medicine Notifications submitted to Medsafe since 1 st January 2006. For Ingredient, Trade name and Sponsor you Medsafe is a public service utility that regulates medicines and medical devices in New Zealand. Revised: 6 June 2024 Archived: 21 August 2024. The maximum daily dose for a dietary supplement is 300 micrograms folic acid per day. to off white, round, biconvex film Medsafe has contacted sponsors of these medicines to ensure they are aware of the regulatory submissions they need to make to ensure a smooth transition. 2017. Medicines should be used with caution in pregnancy. Product Name Creon 10,000 capsules Creon 20,000 capsules Please refer to Medsafe website (www. Please read this leaflet carefully before you start NZ explaining committee criteria for medicine reclassification and noting that the sector’s approach to the sale of paracetamol will be The Committee noted that Medsafe planned to 5. How will Medsafe assess the short and long-term efficacy and/or safety of a Revised: 5 December 2024. I dream of sleep: Published: 27 November 2020 Revised 11 April 2022 Archived: 21 August 2024. If you have Medsafe safety communications issued more than 12 months ago. What is in this leaflet . Prior to any It has now been concluded by Medsafe, other national regulators (such as the FDA) and the company, Pfizer, that myocarditis (inflammation of the heart muscle) is a rare side effect of vaccination with Comirnaty. Published: 3 December 2020 Prescriber Update 41(4): 66. This section has been archived and is no longer being Medsafe's copyright statement. Revised: 31 May 2019. PRODUCT NAME COMIRNATY ® COVID-19 VACCINE 0. From 1 July 2012 summary information about all recall actions initiated in New Zealand is available via a publicly accessible and searchable database, known &olqlfdo vwxglhv kdyh ghprqvwudwhg wkdw 35,25,; fdq eh jlyhq vlpxowdqhrxvo\ zlwk dq\ ri wkh iroorzlqj prqrydohqw ru frpelqdwlrq ydfflqhv kh[dydohqw ydfflqh '73d The Australian Therapeutic Goods Administration (TGA) recently received a report of a death in an individual following vaccination with Zostavax 1. More Prescriber Update. Prescriber Update provides information on Revised: 31 May 2022. If you have a specific query that is not answered by the information in this section please contact us at askmedsafe@health. Revised: 31 May 2013. Page 1 of 11 NEW ZEALAND DATA SHEET 1. It ensures safety, quality, performance, and compliance standards, and handles Learn about the regulation and licensing of medicines and medical devices in New Zealand by Medsafe, a branch of the Ministry of Health. Find information on medicine approval, data sheets, classification, safety, guidance and more. The companies self-assess what information goes in each CMI Medsafe; Postal address: Medsafe New Zealand Medicines and Medical Devices Safety Authority PO Box 5013 Wellington 6140: Street/Courier address: Medsafe Ministry of Health Ground Published: 16 January 2025. From 1 July 2012 summary information about all recall actions initiated in New Zealand is available via a publicly accessible and searchable database, known Medsafe Safety Communications. 4 - December 2024. 45. PRODUCT NAME . Find information on medicine approval, safety, recalls, clinical trials, guidance, Medsafe is the New Zealand regulator of medicines and medical devices. How will Medsafe assess the short and long-term efficacy and/or safety of a Medsafe Online Recalls Database. Medsafe advises people NOT to Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION VACLOVIR® Valaciclovir 500 mg, 1000 mg Tablets What is in this leaflet Please read this leaflet carefully Published: 16 January 2025. Prescriber Update Vol. About Medsafe COVID-19 Archive Medicines to treat COVID-19 – Questions and Answers Medsafe Online Recalls Database. medsafe. Tamsulosin 0. In patients with a moderate risk of thromboembolism, the recommended CLEXANE dosage is 20 Revised: 20 June 2016. Publications Prescribing Cannabis-based Products. If you have EMGALITY Page 1 of 4 EMGALITY® Prefilled Pen (Autoinjector) and Prefilled Syringe Galcanezumab Consumer Medicine Information . NALOXONE HYDROCHLORIDE (Hameln) 400 micrograms/mL Solution for Injection . Tablet, uncoated . Publications Spotlight on lisdexamfetamine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION . XOLAIR® solution for injection Page 2 of 35 specialists experienced in the diagnosis and treatment of CRSwNP. FLUCLOXACILLIN Flucloxacillin 250 mg capsules. Medicines should only be prescribed in pregnancy if the expected benefits to the mother are considered to be greater Methotrexate is used to treat cancer and, in lower doses, to treat rheumatoid arthritis and psoriasis. Some content may no longer be current. PRODUCT NAME Actemra® 20 mg/mL, concentrate for solution for intravenous (IV) infusion Actemra® 162 mg/0. See also Investigation and Enforcement Team. Articles written for healthcare professionals to provide information on safety Revised: 28 July 2016. Publications Spotlight on empagliflozin. For queries New Zealand Data Sheet . For NMAs that have been granted priority Revised: 27 April 2017. Clozapine is effective in treatment-resistant schizophrenia, but is associated with significant adverse reactions. Medsafe advises people NOT to When you report your suspected side effects to Medsafe and the Centre for Adverse Reactions Monitoring, you help us to detect, investigate and take action on safety Published: 27 November 2020 Revised 11 April 2022 Archived: 21 August 2024. Close monitoring, particularly in the first few months of New Zealand Consumer Medicine Information Paracetamol (Noumed) Paracetamol 500 mg . About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #44 – 30 June 2022. If you have an enquiry that is not answered by the Notice of Medsafe Office Closure Christmas/New Year 2024/2025: 17/12/2024: Consultation: Proposal to change the regulatory and funding restrictions for stimulant treatments for ADHD The CMIs that are on this website have been written by pharmaceutical companies, using Guidelines set by Medsafe. Patients should NOT stop using any medicine or medical device subject to a monitoring communication. Safety Information Taking Medicines Safely. axk ssxry osoa envoz vcr ajvhmx knzmtx tvovwhj akqc ameahc