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Diễn biến quy định từ FDA, EMA, TGA và các cơ quan toàn cầu

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24 thg 8, 2026•1 phút đọc
CHM Temporarily Restricts IXCHIQ Chikungunya Vaccine for 65+ Age Group
The CHM has temporarily restricted the IXCHIQ Chikungunya vaccine for people aged 65 and older after very rare fatal reactions were reported globally.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA alerts to falsified Mounjaro KwikPen 15mg supplied via UK online pharmacy
A counterfeit tirzepatide (Mounjaro) KwikPen 15 mg batch D873576 was identified from a UK online pharmacy, prompting a safety alert.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA alerts on congestion from xylometazoline/oxymetazoline sprays
MHRA warns that nasal decongestant sprays containing xylometazoline or oxymetazoline can cause rebound congestion when their effect wears off.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA Updates Safety Warnings for Finasteride and Dutasteride Over Suicide Risk
The UK regulator advises new measures to reduce suicide risk linked to finasteride and dutasteride.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA reminds of serious amiodarone risks and need for patient monitoring
Amiodarone linked to life‑threatening lung, liver and thyroid side effects; MHRA urges healthcare professionals to supervise and review patients.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA Alerts on Delayed Angioedema: Distinguish Bradykinin vs Histamine Types
Healthcare professionals warned of delayed angioedema onset and need to differentiate bradykinin‑ and histamine‑mediated cases, as treatments differ.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA Issues Updated Warning on Botulinum Toxin Type‑A Products Over Risk of Iatrogenic Botulism
The UK Medicines and Healthcare products Regulatory Agency reports cases of iatrogenic botulism after therapeutic or cosmetic use of botulinum toxin type‑A, urging immediate medical attention if symptoms arise.
UPDATED
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24 thg 8, 2026•1 phút đọc
MHRA adds contraindication for domperidone in pheochromocytoma patients
MHRA updates domperidone product information to contraindicate use in confirmed or suspected pheochromocytoma due to severe hypertension risk.
UPDATED
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24 thg 8, 2026•1 phút đọc
PMDA Safety Notice: Incorrect Dose Risks with Insulin‑Specific Syringes
The Pharmaceuticals and Medical Devices Agency (PMDA) issued a safety alert warning that using insulin‑specific syringes incorrectly may cause serious adverse health effects.
UPDATED
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24 thg 8, 2026•1 phút đọc
PMDA Updates Japanese Pharmacopoeia with PDG Harmonized Texts
The Pharmaceuticals and Medical Devices Agency announced that PDG harmonized texts have been incorporated into updated Japanese Pharmacopoeia monographs.
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UPDATED
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24 thg 8, 2026•1 phút đọc
PMDA Updates ATC Learning Videos
PMDA has refreshed its ATC learning video series, providing updated educational content for pharmaceutical professionals.
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UPDATED
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24 thg 8, 2026•1 phút đọc
PMDA releases seven English translations on pediatric drug development guidance
The PMDA published seven English translations of notifications and administrative notices related to pediatric drug development, including a revision of the planning guidance for adult drug programs.
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