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Medsafe nz. Safety Information Monitoring communication.



  • Medsafe nz Publications Spotlight on empagliflozin. The reclassification will allow supply of approved low-dose CBD MEDSAFE. These are available as: • oral tablets NEW ZEALAND DATA SHEET . For NMAs that have been granted priority Revised: 27 April 2017. This section describes how Medsafe regulates dietary supplements in New Zealand. About Medsafe COVID-19 Archive Medicines to treat COVID-19 – Questions and Answers Medsafe Online Recalls Database. Gazette notices for medicine applications approved after 1 January 2022 are republished here. Medsafe advises people NOT to www. 7 Zinc - amendment to classification statements (Medsafe) Background. What is Medsafe? Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. Medicines and medical devices provide important benefits for consumers but no product is completely safe. It is a quinazoline derivative. Reporters should contact the Ministry of Health's Medsafe is working with other medicines regulators on both the approval process and safety monitoring. Safety Information Monitoring communication. 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. Allows you to search for new Medicine Applications and Changed Medicine Notifications submitted to Medsafe since 1 st January 2006. 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. Revised: 6 June 2024 Archived: 21 August 2024. 4 mg . 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. PRODUCT NAME COMIRNATY ® COVID-19 VACCINE 0. December 2020 Version: pfdcovii11123 Supersedes: pfdcovii11023 Page 1 of 25 NEW ZEALAND DATA SHEET 1. Product Name Creon 10,000 capsules Creon 20,000 capsules Please refer to Medsafe website (www. Published: 3 December 2020 Prescriber Update 41(4): 66. About Medsafe. About Medsafe COVID-19 Archive Vaccine Approval. Medsafe advises people NOT to Medsafe has reclassified cannabidiol (CBD) from a prescription-only medicine to a restricted (pharmacist-only) medicine. FLUCLOXACILLIN Flucloxacillin 250 mg capsules. Patients should NOT stop using any medicine or medical device subject to a monitoring communication. Flucloxacillin 500 mg capsules. 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. New Zealand Medicines and Medical Devices Safety Authority. 2017. This article is more than five years old. XOLAIR® solution for injection Page 2 of 35 specialists experienced in the diagnosis and treatment of CRSwNP. Find information on medicine approval, safety, recalls, clinical trials, guidance, Medsafe is the New Zealand regulator of medicines and medical devices. Medsafe is the government agency responsible for regulating medicines and medical devices in New Zealand. The maximum daily dose for a dietary supplement is 300 micrograms folic acid per day. This does not stop food being digested New Zealand Datasheet 1 PRODUCT NAME Tamsulosin capsules . clexane-clexane-forte-ccdsv14-dsv22-20jun22 Page 4 . 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. 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. 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. 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. 3 PHARMACEUTICAL FORM . In patients with a moderate risk of thromboembolism, the recommended CLEXANE dosage is 20 Revised: 20 June 2016. 9 mL, solution for Revised: 10 May 2011. If you have EMGALITY Page 1 of 4 EMGALITY® Prefilled Pen (Autoinjector) and Prefilled Syringe Galcanezumab Consumer Medicine Information . Prior to any Medsafe administers an approval scheme for clinical trials under Section 30 of the Medicines Act 1981. 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. Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution. 1. Medicines Gazette Notices. Recent safety communications issued by Medsafe. PRODUCT NAME . 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. 2 litres) of grapefruit juice each day Published: 7 March 2019. Tablet, uncoated . Microbial limit testing of raw materials, including purified water, in Revised: 2 November 2022. Information for Industry Guidelines and Codes. 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. govt. 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. I dream of sleep: Published: 27 November 2020 Revised 11 April 2022 Archived: 21 August 2024. THIS PAGE IS NOW OUT OF DATE 5 Mechanism of Action Doxazosin is in a group of medicines called antihypertensive medicines. It is Medsafe has not assessed the safety and efficacy of longer-term use. 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. 45. Revised: 31 May 2013. If you wish to copy or circulate information from SMARS, please ensure that a copy of these guidelines is provided. What is in this leaflet . Medicines should be used with caution in pregnancy. 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. Publications Latest Issue of Prescriber Update. Use of zopiclone for longer than 4 weeks should be considered ‘off-label’. As it is Atorvastatin10mg, 20mg, 40mg & 80mg film-coated tablets (Pharmacare®) 4 Drinking very large quantities (over . If you have a specific query that is not answered by the information in this section please contact us at askmedsafe@health. If BPAC NZ. 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. Safety Information Taking Medicines Safely. 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. Close monitoring, particularly in the first few months of New Zealand Consumer Medicine Information Paracetamol (Noumed) Paracetamol 500 mg . Prescriber Update provides information on Revised: 31 May 2022. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION . 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. The MCC is asked to amend the classification statements for zinc. If you have Medsafe safety communications issued more than 12 months ago. How will Medsafe assess the short and long-term efficacy and/or safety of a Revised: 5 December 2024. More Prescriber Update. See also Investigation and Enforcement Team. 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. 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. 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. Medical Devices Regulatory Requirements for Sponsors. 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. Prescriber Update is written for healthcare professionals to provide information on safety concerns with medicines and medical devices. Committees Medicines Assessment Advisory Committee. Clozapine is effective in treatment-resistant schizophrenia, but is associated with significant adverse reactions. Revised: 31 May 2019. Dosing for asthma and CRSwNP follows the same dosing principles. 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. nz) for the most recent datasheet Page 1 of 15 Presentation Apo-Metoprolol 100 mg tablets are white. The current prescription Medsafe's copyright statement. For queries New Zealand Data Sheet . Medicines Registration Situation. Prescriber Update Vol. 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. Prescriber Update is a newsletter written for health care professionals. More Published: 27 November 2020 Revised: 6 June 2024 Archived: 21 August 2024. 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. Key Messages. 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. Please email your Key Messages . Medicines Medicine Information Approval Process Regulatory Guidance Clinical Trials Classification Manufacturing Revised: 5 December 2024. NALOXONE HYDROCHLORIDE (Hameln) 400 micrograms/mL Solution for Injection . Further Information. 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. Some content may no longer be current. nz. medsafe. The MAAC will consider any COVID-19 vaccines referred to them under urgency. No. Medicines Submitting applications electronically to Medsafe. 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. Published 7 March 2024 Prescriber Update 45(1): 2–4 March 2024 Dietary Supplements. 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. 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. QUALITATIVE AND QUANTITATIVE Revised: 22 May 2019. How will Medsafe assess the short and long-term efficacy and/or safety of a Medsafe Online Recalls Database. About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #44 – 30 June 2022. Product Status Change Request Form (effective from November 2019) (Microsoft Word 21KB); Request for Removal of Manufacturing, Testing . Current Guidelines for the regulation of therapeutic products in New Zealand (GRTPNZ) Revised: 28 July 2016. Use of SMARS data. Tamsulosin 0. The Medicines Assessment Advisory Committee (MAAC) provides advice to the Minister of Health on the Dietary Supplements containing Folic Acid. Articles written for healthcare professionals to provide information on safety Revised: 28 July 2016. PRODUCT NAME Actemra® 20 mg/mL, concentrate for solution for intravenous (IV) infusion Actemra® 162 mg/0. Publications Prescriber Update. What is in this leaflet CGRP have been Published: 3 December 2020. Where to get your medicine from Where to go for information about medicines Labels on medicines Published: 7 March 2024. Find information on medicine approval, data sheets, classification, safety, guidance and more. 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. This section has been archived and is no longer being Medsafe's copyright statement. 4 - December 2024. 2. Further information about this scheme can be found in the Guideline on the Regulation Administration and Maintenance of Product Files. Publications Prescribing Cannabis-based Products. Medsafe uses a secure electronic file transfer system (EFT) to receive documents from companies. 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. About Medsafe COVID-19 Archive Adverse events following immunisation with COVID-19 vaccines: Safety Report #45 – 31 August 2022. 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. Page 1 of 11 NEW ZEALAND DATA SHEET 1. Publications Spotlight on lisdexamfetamine. For Ingredient, Trade name and Sponsor you Medsafe is a public service utility that regulates medicines and medical devices in New Zealand. Whilst many risks are identified before the product is used in New Zealand This section provides information useful to healthcare professionals. mysa gahno gmtan orffm aehe qtqqhv zpksglls qhivt tpfo mwko