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- Pertandingan Perarakan (Parade) sempena Majlis Perasmian Sambutan Ulang Tahun Bandaraya Petaling Jaya ke-18 dan Pra-Pelancaran Petaling Jaya International Folklore Festival 2025
- Kunjungan Hormat oleh Mr. Micheal Wiseman, Ketua Cawangan Regulatori Antarabangsa, Therapeutic Goods Administration (TGA), Australia
- Lawatan Kerja Rasmi YB Menteri Kesihatan Malaysia ke NPRA
- Vaccine Announcement
- Tawaran Iklan Sebut Harga
- Safety Alerts 2019
- Carbimazole and methimazole (thiamazole): (i) Risk of birth defects and neonatal disorders in case of exposure during pregnancy; (ii) Risk of pancreatitis
- Benlysta® (belimumab): Increased risk of serious psychiatric events
- DARZALEX (daratumumab): New identified risk of Hepatitis B Virus reactivation
- Deferiprone: Risk of neurological disorders in children
- Posaconazole: Pseudohyperaldosteronism
- TECENTRIQ® (atezolizumab): A new important identified risk – immune-related myositis
- Imovane® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence
- Actemra® (tocilizumab): New important identified risk of hepatotoxicity
- Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome
- LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis
- Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation
- Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women
- FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study
- Retinoids: Updated measures for pregnancy prevention during retinoids use
- Oral retinoids: Risk of neuropsychiatric symptoms
- Tapentadol: Risk of seizures and reports of serotonin syndrome when co-administered with other drugs
- Xylometazoline: Increased risk of serious ventricular arrhythmia in patients with long QT syndrome
- Direct-Acting Antivirals (DAAVs) : Risk of hypoglycaemia in patients with diabetes
- Beta-Lactam antibiotics: Severe Cutaneous Adverse Reactions (SCARs)
- Ceftriaxone: Disturbed consciousness, convulsions or involuntary movements
- Lamotrigine: Risk of hemophagocytic lymphohistiocytosis (HLH)
- Acetazolamide: A new contraindication during pregnancy
- Fluoroquinolones: Risk of aortic aneurysm and dissection
- Epilim® (Sodium Valproate): Important new restrictions on use
- Safety Alerts 2020
- New safety measure for sodium valproate: (i) Risk of congenital malformation in neonates and neurodevelopmental problems in children exposed to sodium valproate during pregnancy; (ii) Additional educational material for healthcare professionals and patients/caretakers
- Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors: Risk of severe lung inflammation
- Ondansetron: Birth defects
- Sulfasalazine: Interference with dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH) reaction assays
- Esbriet® (pirfenidone): Drug-induced liver injury (DILI)
- Kyprolis® (carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation
- Nivolumab: Reports of cytomegalovirus (CMV) infection or reactivation
- Intravenous iron-containing products: Kounis syndrome
- Esmya (ulipristal acetate 5 mg): Product recall due to potential risk of liver injury
- Guselkumab: Risk of anaphylaxis
- Nintedanib: Ischaemic colitis
- Rocuronium: Kounis syndrome
- Gabapentin: Risk of dysphagia
- Proton pump inhibitors: Risk of microscopic colitis
- Domperidone: Restriction of use in paediatric patients less than 12 years of age
- Reminder on the risk of oculogyric crisis with metoclopramide use
- Insulin: Risk of cutaneous amyloidosis
- Topiramate: Risk of uveitis
- Plaquenil® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management
- Propofol: Risk of priapism
- Parenteral nutrition containing amino acids and/or lipids: Risk of toxic degradations of ingredients when exposed to light, which may lead to adverse outcomes in paediatric patients less than 2 years of age
- Gilenya® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception
- Esmya (ulipristal acetate 5 mg): Withdrawal of product registration
- Safety Alerts 2021
- Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]
- Clindamycin: Risk of Acute Renal Failure
- Sulfamethoxazole & Trimethoprim (Co-Trimoxazole): Risk of Acute Respiratory Distress Syndrome (ARDS)
- Decitabine: Risk of Differentiation Syndrome
- Anastrozole: Risk of Depression
- Vascular endothelial growth factor (VEGF) inhibitors for systemic use (except application on eyes): Risk of artery dissections and aneurysms
- Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
- Antidepressants (citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine; vortioxetine): Risk of Postpartum Haemorrhage (PPH)
- Oseltamivir: Risk of Haemorrhages
- Mycophenolate Mofetil (MMF) and Myocophenolic Acid (MPA): Risk of De Novo Purine Synthesis Inhibitors-Associated Acute Inflammatory Syndrome
- Sacubitril/Valsartan: Risk of Psychiatric Events
- Non-Vitamin K Antagonist Oral Anticoagulants (NOACs): Risk of Abnormal Uterine Bleeding
- Bortezomib: Risk of Guillain-Barré Syndrome and Demyelinating Polyneuropathy
- Mirtazapine: Risks of (i) Amnesia and (ii) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Ceftriaxone: Risk of encephalopathy
- Tumour Necrosis Factor alpha (TNFα): Kaposi’s Sarcoma
- Alemtuzumab (Lemtrada®): Revised indication, additional contraindications and risk minimisation measures
- Ondansetron: Information updates on risk of birth defects
- Abiraterone: Risk of hypoglycaemia due to drug interaction
- Clozapine: Risk of serious bowel complications caused by constipation
- Oseltamivir: Thrombocytopenia
- Mesalazine and sulfasalazine: Nephrolithiasis
- Efavirenz (including combination products): Risk of late onset neurotoxicity
- Safety Updates on COVID-19 Vaccine (Comirnaty®)
- Safety Alerts 2022
- Pneumococcal Polysaccharide Vaccine (23-Valent): Extensive Swelling of Vaccinated Limb
- Sorafenib: Risk of Thrombotic Microangiopathy (TMA)
- Hydroxychloroquine and Chloroquine: Risk of Hepatic Impairment
- Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]
- Methadone: Risk of Hypoglycaemia
- Piperacillin: Risk of Haemophagocytic Lymphohistiocytosis (HLH)
- Iodinated Contrast Media: Risk of Hypothyroidism (Particularly in Newborns and Young Children)
- Safety Updates on COVID-19 Vaccines: Risk of Tinnitus
- Labetalol: Risk of Nipple Pain and Raynaud's Phenomenon of the Nipple
- Sertraline: Risk of Microscopic Colitis
- Nirmatrelvir/ Ritonavir (PAXLOVID): Risk of Anaphylaxis and Hypersensitivity Reactions
- Brolucizumab (Pagenax®): Risk of Intraocular Inflammation, Including Retinal Vasculitis and/or Retinal Vascular Occlusion (Updated Recommendations to Minimise the Known Risks)
- Alectinib (Alecensa®): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance)
- Metformin: Risk of Vitamin B12 Deficiency
- Corticosteroids (Systemic): Risk of Pheochromocytoma Crisis
- Loperamide: Risk of Acute Pancreatitis
- Chloroquine and Hydroxychloroquine: Risk of Psychiatric Disorders
- Empagliflozin: Risk of Tubulointerstitial Nephritis
- Olmesartan: Risk of Autoimmune Hepatitis
- Mavenclad® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring
- Azathioprine: Risk of Erythema Nodosum
- Safety Updates on COVID-19 Vaccines: Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) / Thrombosis with Thrombocytopenia Syndrome (TTS)
- Betamethasone (Systemic): Risk of Pheochromocytoma Crisis
- Hydrochlorothiazide, Chlorthalidone, Indapamide and Acetazolamide: Risk of Choroidal Effusion, Acute Myopia & Acute Angle-Closure Glaucoma
- Warfarin: Risk of Anticoagulant-Related Nephropathy (ARN)
- Tenofovir Alafenamide: Risk of Renal Adverse Effects
- Safety Alerts 2023
- [Updated] Loperamide: Risk of Acute Pancreatitis
- Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
- Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness
- Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction
- Cephalosporins: Risk of Seizures
- Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- [Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury
- Third-Generation Aromatase Inhibitors (Anastrozole; Exemestane; Letrozole): Risk of Tendon Disorders
- Statins: Risk of Inducing or Aggravating Myasthenia Gravis
- Terlipressin (Glypressin®): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS)
- Griseofulvin: Risk of Severe Cutaneous Adverse Reactions (SCARs)
- Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding
- Azacitidine: Risk of Differentiation Syndrome
- Off-Label Use of Diclofenac Suppositories to Treat Fever in Children: Potential Risk of Acute Necrotising Encephalopathy of Childhood (ANEC)
- [Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
- [Updated] Pholcodine: Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)
- Donepezil: Risk of QT Prolongation and Torsade de Pointes
- Safety Alerts 2024
- [Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
- Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
- 17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data
- Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis
- Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
- Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
- Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
- Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero
- Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
- Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum
- Amoxicillin: Risk of Aseptic Meningitis
- Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration
- [Updated] Olmesartan: Risk of Autoimmune Hepatitis
- Proton Pump Inhibitors: Risk of Erectile Dysfunction
- Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)
- [Updated] Metformin: Risk of Vitamin B12 Deficiency
- Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
- Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours
- Imatinib: Risk of Thrombotic Microangiopathy
- Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
- Rivastigmine: Risks of QT Prolongation and Torsade de Pointes
- Uncategorised
- Senarai Pengilang Kosmetik di Sistem QUEST
- Panduan Menjalankan Penyelidikan di Program Perkhidmatan Farmasi
- Persidangan Penyelidikan dan Pembangunan (R&D) Farmasi Kebangsaan Ke -12
- Kolaborasi R&D
- Garis Panduan & Borang
- Pelaporan Kesan Sampingan oleh Ubat-ubatan atau vaccine keatas Pengguna
- Laporan Tahunan Pusat Pemonitoran Kesan Advers Ubat
- Senarai Pengimport Berlesen di Sistem QUEST
- Senarai Pemborong Berlesen di Sistem QUEST
- Senarai Pengilang Berlesen di Sistem QUEST
- Produk Ubat Baru (NCE)
- Berita Keselamatan Ubat REAKSI
- Main Menu For Information (MAKLUMAT)
- New Drug Products (NCE)
- REAKSI Drug Safety News (Berita Keselamatan Ubat REAKSI)
- Laporan Tahunan Pusat Pemonitoran Kesan Advers Ubat
- Newsletter: Berita Ubat-ubatan (Buletin: Berita Ubat-ubatan)
- About NPCB
- Ahli MADRAC
- Piagam Pelanggan NPRA
- Anggota PBKD
- Ahli MADRAC
- Pengenalan MADRAC
- Berita PBKD
- Mengenai Pihak Berkuasa Kawalan Dadah (PBKD)
- Carta Organisasi
- OECD-GLP-MAD
- PIC/S
- Pusat Kolaborasi WHO Bagi Kawalan Regulatori Farmaseutikal
- Pengiktirafan dan Anugerah yang diterima NPRA
- Fungsi dan Peranan
- Tahap Pencapaian Perkhidmatan Tahun Terkini
- Healthcare Professional
- QUEST basic
- PENGUMUMAN
- Direktif Berkenaan Keperluan Mendaftar Penyelidikan Klinikal Sukarelawan Sihat Dengan National Healthy Research Volunteer Register (NHRVR) Kepada Sponsor/Pemohon/Penyelidik Yang Memohon Lesen Import Percubaan Klinikal (CTIL) Dan Kelulusan Mengilang (CTX) (3)
- Additional Indications Approved (2)
- Laporan Tahunan NPRA 2018
- Produk Baru Yang Diluluskan
- Tambahan Indikasi yang Diluluskan
- Pengumuman 2019
- SESI e-ENGAGEMENT: PELAKSANAAN PELAN BERFASA PEMERIKSAAN AMALAN PENGEDARAN BAIK (AEB) SECARA RUTIN KE ATAS PENGIMPORT DAN PEMBORONG PRODUK RANGKAIAN SEJUK / ‘TIME & TEMPERATURE SENSITIVE PRODUCT’ (TTSP)
- Pengilang Farmaseutikal, Radiofarmaseutikal dan Veterinar:Pembayaran Fi Pemeriksaan APB Secara Pra Bayar
- Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik:Tindakan Regulatori kerana Kegagalan Menjelaskan Fi Pemeriksaan APB
- Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020
- Peringatan: Pelaksanaan Kawalan Regulatori Bahan Aktif Farmaseutikal (API) Untuk Produk Yang Tamat Tempoh Pendaftaran Mulai 1 Januari 2020
- Permohonan Pembaharuan Lesen Pengilang / Mengimport / Pemborong untuk Tahun 2020
- Verifikasi Terjemahan Dokumen Rasmi
- Pengumuman 2021
- Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synchron Research Services dan Panexcell Clinical Lab Susulan Penemuan Pemeriksaan United States Food and Drug Administration (US FDA)
- Direktif Berkenaan Keperluan Mendaftar Penyelidikan Klinikal Sukarelawan Sihat Dengan National Healthy Research Volunteer Register (NHRVR) Kepada Sponsor/Pemohon/Penyelidik Yang Memohon Lesen Import Percubaan Klinikal (CTIL) Dan Kelulusan Mengilang (CTX) (2)
- Pengumuman 2022
- Pengumuman 2023
- Pemakluman Pertukaran Tempat Penganjuran National Regulatory Conference (NRC) 2023 ke M Resort & Hotel, Kuala Lumpur
- Pengisytiharan Status Pendaftaran Produk di Negara Lain untuk Ubat Generik dalam Sistem QUEST
- Kajian Kepuasan Pelanggan NPRA
- Pemakluman Penggunaan Screening Checklist untuk Produk Generik (Prescription-Full)
- Bioequivalence
- Application Form
- Siaran Akhbar 2019
- Penjualan Produk Herba Untuk Memulih & Mencegah Demam Denggi
- Kenyataan Akhbar Kementerian Kesihatan Malaysia : Produk Tradisional Nan Bao (Capsule) Dikesan Mengandungi Racun Berjadual Sildenafil
- Kenyataan Akhbar KPK 1 April 2019 – Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual
- Kenyataan Akhbar KPK 29 Januari 2019 – Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
- Kenyataan Akhbar KPK 23 Mei 2019 -Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual
- Kenyataan Akhbar KPK 6 Ogos 2019 -Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual
- MedSafetyWeek2022
- 😊 Hey, are you a pharmacist? 💊
- 💊 How Medication Safety Works? 👨⚕️🏥👩⚕️
- 😊 Thank you for joining #MedSafetyWeek 💊
- 🤒 Have you ever experienced a side effect from a medicine? 😵
- 💫 When you report a suspected side effect from a medicine, we learn more about it 💡
- #MedSafetyWeek Starts Today! 💊
- Why do We Monitor the Safety of Medicines?🔎
- 🙋♂️ How Can You Help Us in Making Medicines Safer for Everyone? 🙋
- Get Ready for #MedSafetyWeek!
- MedSafetyWeek2021
- MedSafetyWeek2023
- Thanks for Joining #MedSafetyWeek 2023 💖
- Hello 👋 Are You a Pharmacist? 🧑⚕👩
- Hi! Are You a Nurse? 🏥
- Hey, Are You a Doctor? 👨⚕️🏥👩⚕️
- Sleep Troubles After Medication 😵? Remember to Report Them 📝
- Concerned About Side Effects? Remember to check 👀 , talk 🗣 , and tell 💬 this #MedSafetyWeek!
- 💊 Medications in Malaysia are Continually Monitored to Ensure Their Safety 🔎
- Preparations for #MedSafetyWeek are well underway – are you ready?
- 📣 #MedSafetyWeek kicks off today!
- Unexpected Side Effects Can Happen Anywhere, at Any Time: Your Report, Patients' Safety 💊
- Get Ready for #MedSafetyWeek 2023!
- MedSafetyWeek2024
- ❓ 5️⃣Questions to Ask Your Patients to Help Prevent Side Effects 💊
- 💊 Medicines Are Continually Monitored to Ensure Their Safety 🔍
- 🙏Thanks for Joining #MedSafetyWeek! 💊🌍
- 💊 Not All Medicines Are Equal ⚖️
- ❓ 5️⃣Questions to Ask Your Healthcare Professional to Help Prevent Side Effects 💊
- 📆 Join Us Next Week for #MedSafetyWeek!
- We’re Ready for #MedSafetyWeek – Are You? ⏱️
- 📣 #MedSafetyWeek Starts Today!
- 💊 Prevent Side Effects by Taking Medicines the Right Way! ✅
- Not All Medicines Are Suitable for Everyone 👶👧🏾👦👨🏻👴👵🤰🏻
- Dasar Privasi Aplikasi Mudah Alih
National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
- Phone: +603-7883 5400
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- Last Modified: Selasa 24 Disember 2024, 09:00:56.