Application Forms for Clinical Trial
published on 2024-12-20
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Frequently Asked Questions (FAQs): Appendix 19 General Labelling Requirement for Products Containing Animal-Derived Materials
published on 2024-12-13
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Biosimilar Approved
published on 2024-12-09
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New Drug Products (NCE)
published on 2024-12-05
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List of Renewal Approved Veterinary Products
published on 2024-12-05
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Additional Indications Approved
published on 2024-12-05
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New Products Approved
published on 2024-12-05
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[Updated November 2024] Product Classification Form - NPRA/413/01-3
published on 2024-11-28
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Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application
published on 2024-11-21
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Direktif berkenaan larangan penggunaan chloroform/chloroform spirit sebagai pengawet dalam produk farmaseutikal, produk semula jadi dan produk suplemen kesihatan
published on 2024-11-19
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MADRAC Members
published on 2024-11-18
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Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance
published on 2024-11-15
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🙏Thanks for Joining #MedSafetyWeek! 💊🌍
published on 2024-11-10
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💊 Medicines Are Continually Monitored to Ensure Their Safety 🔍
published on 2024-11-09
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❓ 5️⃣Questions to Ask Your Patients to Help Prevent Side Effects 💊
published on 2024-11-07
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❓ 5️⃣Questions to Ask Your Healthcare Professional to Help Prevent Side Effects 💊
published on 2024-11-07
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💊 Not All Medicines Are Equal ⚖️
published on 2024-11-06
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Not All Medicines Are Suitable for Everyone 👶👧🏾👦👨🏻👴👵🤰🏻
published on 2024-11-05
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Kenyataan Media Kementerian Kesihatan Malaysia - Pelancaran Minggu Keselamatan Ubat #MedSafetyWeek 2024
published on 2024-11-05
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💊 Prevent Side Effects by Taking Medicines the Right Way! ✅
published on 2024-11-04
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Sesi Libat Urus antara Bahagian Regulatori Farmasi Negara (NPRA) bersama Pihak Berkepentingan (STAKEHOLDERS)
published on 2024-11-04
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📣 #MedSafetyWeek Starts Today!
published on 2024-11-04
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We’re Ready for #MedSafetyWeek – Are You? ⏱️
published on 2024-10-31
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📆 Join Us Next Week for #MedSafetyWeek!
published on 2024-10-28
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[Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
published on 2024-10-14
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Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
published on 2024-10-10
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KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA 8 OKTOBER 2024 - KELULUSAN PENDAFTARAN BAGI PRODUK SEMULA JADI DENGAN TUNTUTAN MODEN
published on 2024-10-08
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Data Exclusivity
published on 2024-10-04
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Kenyataan Media KKM 02 Oktober 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-02
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Kenyataan Media KKM 30 September 2024- Makluman Produk-Produk Kosmetik yang Dikesan Mengandungi Racun Berjadual
published on 2024-10-01
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Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero
published on 2024-10-01
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Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
published on 2024-09-30
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Prosedur dan Kriteria Pelanjutan Tempoh Sah Pusat Kajian Bioekuivalens (BE) dan Jawatankuasa Etika yang berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD)
published on 2024-09-19
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Penerbitan Garis Panduan Malaysian Guideline For Bioequivalence Inspection Edisi Kedua
published on 2024-09-19
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Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
published on 2024-09-02
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Garis Panduan Penilaian Kesetaraan Taraf Amalan Perkilangan Baik (APB) Pengilang TMHS Luar Negara, Edisi Pertama, September 2024
published on 2024-08-30
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Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
published on 2024-08-25
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Pengemaskinian Drug Registration Guidance Document (DRGD) Berkaitan Keperluan Deklarasi Bahan Bersumberkan Haiwan Pada Label Produk
published on 2024-08-14
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Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis
published on 2024-08-12
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Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by National Pharmaceutical Regulatory Agency (NPRA)
published on 2024-07-24
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Eighth Revision July 2024
published on 2024-07-23
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17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data
published on 2024-07-19
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Pre-Membership Module Announcement
published on 2024-07-18
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Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
published on 2024-07-15
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Direktif untuk semua produk yang mengandungi Hydroxychloroquine : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Acute Febrile Neutrophilic Dermatosis (Sweet’s Syndrome)
published on 2024-07-11
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Direktif untuk semua produk yang mengandungi Azacitidine (sediaan injeksi sahaja) : Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko Cutaneous Vasculitis
published on 2024-07-11
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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
published on 2024-07-10
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Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum
published on 2024-06-28
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PEKELILING BIL 2/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-06-19
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Orphan Medicines Approved
published on 2024-06-11
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Garis Panduan Persediaan Pemeriksaan APB Bagi Pengilang Pengilang Tradisional, Suplemen Kesihatan dan Kosmetik, Edisi Keempat, Jun 2024
published on 2024-05-31
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Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024
published on 2024-05-30
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Amoxicillin: Risk of Aseptic Meningitis
published on 2024-05-29
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Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration
published on 2024-05-28
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Guideline on Electronic Labelling (E-Labelling) For Pharmaceutical Products in Malaysia
published on 2024-05-21
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[Updated] Olmesartan: Risk of Autoimmune Hepatitis
published on 2024-05-06
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Proton Pump Inhibitors: Risk of Erectile Dysfunction
published on 2024-04-30
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Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2024-04-29
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Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)
published on 2024-04-18
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Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours
published on 2024-04-17
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Direktif untuk semua produk yang mengandungi hydrochlorothiazide (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko Acute Respiratory Distress Syndrome (ARDS)
published on 2024-04-16
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Direktif untuk semua produk yang mengandungi olmesartan (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko hepatitis autoimun (autoimmune hepatitis)
published on 2024-04-16
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Direktif untuk semua produk yang mengandungi Mefenamic Acid: Pengemaskinian Sisip Bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan Generalised Bullous Fixed Drug Eruption (GBFDE)
published on 2024-04-16
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Direktif untuk semua produk yang mengandungi ciprofloxacin, moxifloxacin, levofloxacin dan ofloxacin untuk kegunaan sistemik (sediaan oral dan injeksi) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko suicidal behaviour
published on 2024-04-16
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Direktif untuk semua produk yang mengandungi dapagliflozin, empagliflozin, canagliflozin (termasuk produk kombinasi) dan lithium (untuk tujuan rawatan) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko penurunan paras serum lithium akibat interaksi ubat
published on 2024-04-16
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Direktif berkenaan pendaftaran produk semula jadi berdasarkan Guideline on Natural Products with Modern Claim
published on 2024-04-15
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Makluman Penambahbaikan Proses Pengeluaran Lesen Mengimport / Lesen Pemborong melalui Penilaian dan Pemeriksaan Pra-Pelesenan
published on 2024-04-05
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Information Sharing Paper for Cosmetic Products in the 37th ASEAN Cosmetic Committee Meeting (8-9th May 2023)
published on 2024-03-27
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Guidelines for Clinical Trial
published on 2024-03-20
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Direktif Berkenaan Pengemaskinian Garis Panduan Malaysian Guideline For Application Of Clinical Trial Import Licence (CTIL) And Clinical Trial Exemption (CTX)
published on 2024-03-19
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Iklan Sebut Harga Kerja-Kerja Menaiktaraf Sistem Pendingin Hawa Di Program Perkhidmatan Farmasi, Ibu Pejabat Kementerian Kesihatan Malaysia
published on 2024-03-15
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Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
published on 2024-03-12
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Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2023
published on 2024-03-11
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[Updated] Metformin: Risk of Vitamin B12 Deficiency
published on 2024-03-04
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Direktif berkenaan pelaksanaan Electronic Labelling (e-Labelling) ke atas produk farmaseutikal di Malaysia
published on 2024-02-22
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Direktif berkenaan pindaan kepada proses meluluskan permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Untuk Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) yang melibatkan kajian klinikal First-in-Human (FIH).
published on 2024-02-20
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Direktif Berkenaan Pengemaskinian dan Pelaksanaan Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023
published on 2024-02-19
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Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19
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Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2024-02-19
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Guideline For Facilitated Registration Pathway (FRP)
published on 2024-02-17
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Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
published on 2024-02-15
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Keputusan Mesyuarat Pihak Berkuasa Kawalan Dadah Kali Ke-393
published on 2024-02-09
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Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)
published on 2024-01-23
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Makluman Pengemaskinian Tempoh Jangka Hayat Vaksin COVID-19 iaitu CoronaVac Daripada 30 Bulan Kepada 36 Bulan
published on 2024-01-23
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Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synapse Labs Pvt. Ltd. Susulan Penemuan Pemeriksaan European Medicines Agency (EMA)
published on 2024-01-23
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Imatinib: Risk of Thrombotic Microangiopathy
published on 2024-01-22
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PEKELILING BIL 1/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-01-19
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Seventh Revision January 2024
published on 2024-01-19
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Rivastigmine: Risks of QT Prolongation and Torsade de Pointes
published on 2024-01-19
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Pekeliling berkenaan pengemaskinian syarat pendaftaran midazolam dalam Drug Registration Guidance Document (DRGD)
published on 2024-01-18
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Direktif untuk semua produk yang mengandungi rivastigmine: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko QT prolongation dan Torsade de Pointes (TdP)
published on 2024-01-18
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Direktif untuk semua produk yang mengandungi imatinib: Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) dengan maklumat keselamatan berkaitan risiko thrombotic microangiopathy (TMA)
published on 2024-01-18
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Direktif untuk semua produk yang mengandungi metformin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RIMUP) bagi memperkukuhkan maklumat keselamatan berkaitan risiko kekurangan vitamin B12 (vitamin B12 deficiency)
published on 2024-01-17
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DCA News
published on 2023-12-20
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Pekeliling Berkenaan Pengemaskinian Guidance Document and Guidelines for Registration of Biosimilars in Malaysia
published on 2023-12-18
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Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness
published on 2023-12-01
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Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
published on 2023-11-29
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[Updated] Loperamide: Risk of Acute Pancreatitis
published on 2023-11-29
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[Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
published on 2023-11-28
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Thanks for Joining #MedSafetyWeek 2023 💖
published on 2023-11-11
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