Info Obat dan Regulator Obat Dunia

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FDA Roundup: August 15, 2023
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AstraZeneca Pharmaceuticals LP - 664789 - 08/04/2023
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202
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EMA mourns passing of Noël Wathion, , 14/08/2023
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340
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EMA business hours over Assumption Day, 15 August, , 11/08/2023
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197
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FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients
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238
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FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bu
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227
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FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines
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216
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FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
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224
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FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products
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203
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FDA/PHUSE Computational Science Symposium (CSS) - 09/18/2023
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229
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FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
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253
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FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
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240
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FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from in
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222
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FDA Drug Safety Communication: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
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302
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FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strok
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216
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FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney d
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263
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FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants
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221
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FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
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251
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FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to
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336
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FDA Roundup: August 11, 2023
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214
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