Application Forms for Clinical Trial
published on 2025-12-01
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FAQ: Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
published on 2025-12-01
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MAKLUMAN PENUTUPAN PEMBAYARAN AKHIR TAHUN 2025
published on 2025-11-26
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Cyclin-Dependent Kinase Inhibitors (CDKIs): Interaction with Statins Leading to Potential Risk of Rhabdomyolysis
published on 2025-11-17
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Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Risk of Persistent Sexual Dysfunction
published on 2025-11-14
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Sulfamethoxazole, Trimethoprim (Cotrimoxazole): Risk of Circulatory Shock
published on 2025-11-14
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Amiodarone: Risk of Primary Graft Dysfunction after Heart Transplantation
published on 2025-11-14
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PEMAKLUMAN : PEMULIHAN SISTEM QUEST3+
published on 2025-11-13
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List of Renewal Approved Veterinary Products
published on 2025-11-12
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Additional Indications Approved
published on 2025-11-12
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#MedSafetyWeek turns 10! 🎉
published on 2025-11-09
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That’s a wrap on this year’s #MedSafetyWeek campaign! 🎉
published on 2025-11-09
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SIARAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA PELANCARAN MINGGU KESELAMATAN UBAT #MedSafetyWeek 2025
published on 2025-11-08
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Monitoring the safety of medicines doesn’t stop once they hit the pharmacy shelves
published on 2025-11-08
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4️⃣ Ways Healthcare Professionals can be #MedSafetyHeroes 💊🌍
published on 2025-11-07
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New Products Approved
published on 2025-11-06
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4️⃣ Ways Patients can be #MedSafetyHeroes 💊🌍
published on 2025-11-06
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Medicines safety starts with you and me 🤝
published on 2025-11-05
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Do you know how to be a #MedSafetyHero? 💪❓
published on 2025-11-04
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#MedSafetyWeek 2025 starts today! 🚀
published on 2025-11-03
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We all have the power to be a #MedSafetyHero 👦🏻👧👩🏾👨🏻👵🏼👴🤰🏻
published on 2025-11-03
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#MedSafetyWeek is almost here — Are you ready? 🙌
published on 2025-10-31
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📣 Jom sertai Majlis Pelancaran #MedSafetyWeek 2025
published on 2025-10-24
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Safety Signal Alert: Doxycycline-Fixed Drug Eruption (FDE)
published on 2025-10-13
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OBSOLETE_ Good Tissue Practice Guideline
published on 2025-10-10
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Direktif untuk semua produk yang mengandungi Selective Serotonin Reuptake Inhibitor (SSRI) dan Serotonin-Norepinephrine Reuptake Inhibitor (SNRI): Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko sexual dysfunction berterusan
published on 2025-10-09
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Direktif untuk semua produk yang mengandungi amiodarone: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko primary graft dysfunction (PGD) selepas pemindahan jantung (heart transplantation)
published on 2025-10-09
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Direktif Berkenaan Penggunaan Label Keselamatan Farmatag® Baharu daripada Syarikat Netsmart Sdn Bhd
published on 2025-10-09
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Biosimilar Approved
published on 2025-10-07
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Finasteride and Dutasteride: Risk of Suicidal Thoughts
published on 2025-09-23
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List of GLP Compliant Test Facilities
published on 2025-09-22
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Pekeliling Berkenaan Pengemaskinian Guidance Document And Guidelines For Registration Of Cell And Gene Therapy Products (CGTPs) In Malaysia (Second Edition)
published on 2025-09-22
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Direktif untuk semua produk yang mengandungi Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko aspiration dan pneumonia aspiration semasa anestesia umum (general anaesthesia) atau sedasi penuh (deep sedation)
published on 2025-09-22
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Direktif berkenaan pengemaskinian keperluan Amalan Makmal Baik (Good Laboratory Practice, GLP) dan pelaksanaan pemeriksaan GLP study-specific ke atas fasiliti kajian luar negara bagi kajian keselamatan bukan klinikal untuk tujuan pendaftaran produk New Chemical Entity (NCE), biologik dan produk semula jadi dengan tuntutan terapeutik
published on 2025-09-22
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Directives & Circulars (GCP & GLP)
published on 2025-09-21
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[Updated] Hydroxychloroquine: 1) Small Increased Risk of Major Congenital Malformations in Children Following in utero Exposure; 2) Risk of Drug-Induced Phospholipidosis; 3) Risk of Aggravation of Myasthenia Gravis
published on 2025-09-18
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Safety Signal Alert: Lamotrigine-Erythema Multiforme (EM)
published on 2025-09-17
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[Updated] Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
published on 2025-09-17
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PELAN ANTIRASUAH NPRA
published on 2025-08-27
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Oral Anticoagulants (Apixaban, Dabigatran, Edoxaban, Rivaroxaban and Warfarin): Risk of Atraumatic Splenic Rupture
published on 2025-08-22
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Valproate (Sodium Valproate, Valproic Acid): Potential Risks to Offspring Following Paternal Exposure, and Male Infertility
published on 2025-08-19
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Direktif untuk semua produk yang mengandungi doxycycline : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko Fixed Eruption (FE)/ Fixed Drug Eruption (FDE)
published on 2025-08-18
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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 major congenital malformation di kalangan kanak-kanak yang terdedah kepada hydroxychloroquine dalam kandungan, drug-induced phospholipidosis dan aggravation of myasthenia gravis (MG)
published on 2025-08-18
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Direktif untuk semua produk yang mengandungi Lamotrigine: Pengemaskinian sisip bungkusan dan RiMUP dengan maklumat keselamatan berkaitan risiko Erythema Multiforme (EM)
published on 2025-08-18
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Direktif untuk semua produk yang mengandungi valproate termasuk terbitannya (sodium valproate, valproic acid)
published on 2025-08-18
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Direktif untuk semua produk yang mengandungi medroxyprogesterone acetate (MPA) bagi sediaan injeksi dan oral (dengan dos ≥100mg) : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko meningioma
published on 2025-08-18
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Direktif Berkenaan Penetapan Had Harian dan Pengemaskinian Maklumat Keselamatan Bagi Tartrazine
published on 2025-08-18
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Guidelines related to GCP & GLP
published on 2025-08-12
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Tenth Revision July 2025
published on 2025-07-22
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PEKELILING BIL 1/2025 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2025-07-14
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Direktif Berkenaan Peluasan Skop Produk Yang Melaksanakan Electronic Labelling (E-Labelling) Kepada Kategori Produk Generik-Bukan Racun Berjadual (Over-The-Counter Products, OTC)
published on 2025-07-14
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Direktif Berkenaan Pelaksanaan Pelaporan Gangguan dan Pemberhentian Bekalan Ubat-Ubatan Di Malaysia Berdasarkan Guideline on Reporting of Medicine Shortage and Discontinuation In Malaysia
published on 2025-07-14
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Direktif Berkenaan Pelaksanaan Pengujian Kawalan Kualiti Ke Atas Bahan Aktif Herba Bagi Tujuan Pendaftaran Produk Semula Jadi Dengan Tuntutan Tradisional (Produk Tradisional)
published on 2025-07-14
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Panduan Penggunaan Kod QR bagi Additional Risk Minimisation Materials (aRMM)
published on 2025-07-07
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Rituximab: Risks of Enteroviral Meningoencephalitis and False-Negative Serologic Testing of Infections
published on 2025-07-04
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Bioequivalence & Ethics Committee Section Activities: 2024 Key Activities and Performance
published on 2025-06-11
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Screening Package for New Drug Products and Biologics
published on 2025-06-03
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Angiotensin II Receptor Blockers (ARBs): Risk of Intestinal Angioedema
published on 2025-05-28
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Pekeliling Berkenaan Penggunaan Kod QR oleh Pemegang Pendaftaran Produk (PRH) Bagi Tujuan Pengedaran Additional Risk Minimisation Materials (aRMM) Kepada Anggota Kesihatan dan Pesakit
published on 2025-05-27
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[Updated] Statins: Risk of Inducing or Aggravating Myasthenia Gravis
published on 2025-05-26
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Isotretinoin: Risk of Sacroiliitis and Urethritis
published on 2025-05-26
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FREQUENTLY ASKED QUESTION (FAQ) On the use of CHLOROFORM in product formulation following the directive issued on 19th November 2024: DIREKTIF BERKENAAN LARANGAN PENGGUNAAN CHLOROFORM/CHLOROFORM SPIRIT SEBAGAI PENGAWET DALAM PRODUK FARMASEUTIKAL, PRODUK SEMULA JADI DAN PRODUK SUPLEMEN
published on 2025-05-26
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Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
published on 2025-05-21
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Guidance Document: Verification for Traditional Medicines (TM) & Health Supplements (HS) Manufacturers, Second Edition, May 2025
published on 2025-05-21
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Enoxaparin: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
published on 2025-05-21
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Azathioprine: Risk of Non-Cirrhotic Portal Hypertension (NCPH) / Portosinusoidal Vascular Disease (PVSD)
published on 2025-05-20
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Direktif untuk semua produk yang mengandungi rituximab (sediaan injeksi sahaja) : Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan risiko enteroviral meningoencephalitis dan false negative serologic testing of infections
published on 2025-05-13
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Direktif untuk semua produk yang mengandungi isotretinoin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko sacroiliitis dan urethritis
published on 2025-05-13
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Direktif untuk semua produk yang mengandungi statin (termasuk produk kombinasi): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko myasthenia gravis
published on 2025-05-13
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Senarai Produk Tidak Berdaftar/Berdaftar Tetapi Tidak Dipasarkan Dengan Bilangan Permohonan Ubat Kelulusan Khas (UKK) Tertinggi Bagi Tahun 2024
published on 2025-05-05
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Azithromycin: Rare Risk of Cardiovascular Death
published on 2025-04-24
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Outcome of GVP Inspection Voluntary Phase (2023-2024): Preliminary Key Findings & Trends
published on 2025-04-16
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Direktif berkenaan penambahbaikan proses permohonan pendaftaran produk untuk tujuan eksport sahaja/ For Export Only (FEO) bagi produk farmaseutikal, suplemen kesihatan dan produk semulajadi
published on 2025-04-10
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Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products (3rd Edition, March 2025)
published on 2025-03-27
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Direktif Berkenaan Peluasan Skop Produk Kajian Klinikal First-In-Human (FIH) Untuk Permohonan Lesen Import Percubaan Klinikal (CTIL) dan Kebenaran Untuk Mengilang Produk Tidak Berdaftar Untuk Tujuan Percubaan Klinikal (CTX) kepada Cell and Gene Therapy Product (CGTP)
published on 2025-03-14
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Pengemaskinian Garis Panduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP)
published on 2025-03-07
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Hydroxychloroquine: Small Increased Risk of Major Congenital Malformations in Children Following in utero Exposure
published on 2025-03-04
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Perluasan Skop Keperluan Akreditasi Pusat Kajian Bioekuivalens (BE) dan Pengecualian Penilaian Keperluan Pemeriksaan Kajian BE Bagi Tujuan Pendaftaran Produk
published on 2025-02-19
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Direktif Berkenaan Pengemaskinian Prosedur Permohonan Pertukaran Pemegang Pendaftaran Produk (COH)
published on 2025-02-19
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NPRA Regulatory Updates 2025
published on 2025-02-13
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DCA News
published on 2025-01-23
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Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Ninth Revision January 2025
published on 2025-01-21
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[Updated] Glucagon-like Peptide-1 (GLP-1) Receptor Agonists (Dulaglutide, Liraglutide, Lixisenatide, Semaglutide, and Tirzepatide): Aspiration and Pneumonia Aspiration during General Anaesthesia or Deep Sedation
published on 2025-01-21
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Guidelines for Clinical Trial
published on 2025-01-09
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Ethambutol: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
published on 2025-01-09
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PEKELILING MAKLUMAN BERKENAAN PELAKSANAAN PENILAIAN PROTOKOL ANALISA SEBAGAI PERSEDIAAN PEMINDAHAN TATACARA PENGUJIAN BAGI PRODUK VAKSIN YANG BERDAFTAR DI MALAYSIA
published on 2025-01-07
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PEKELILING BIL 3/2024 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA
published on 2024-12-30
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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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New Drug Products (NCE)
published on 2024-12-05
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Procedures & Forms
published on 2024-11-30
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[Updated November 2024] Product Classification Form - N1-FR-02/2
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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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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