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January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
07 May 2024 07:45 GMT
… (gadopiclenol)
Eovist (gadoxetate disodium)
Gadavist (gadobutrol)
Multihance (gadobenate dimeglumine)
… Lybalvi (olanzapine and samidorphan)
Drug-drug interaction
FDA is evaluating the need … action.
Tetracyclines
Fixed drug eruption
FDA is evaluating the need …
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New GBCA uses 60% less gadolinium
17 Jan 2025 23:59 GMT
… its potential in clinical trials as a promising alternative … from the phase 3 QUANTI trial. The studies are testing … Bayer’s GBCAs, gadobutrol (Gadavist), which uses a gadolinium dose … demonstrating similar efficacy to the trial comparators,” Luetkens said in …
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2023 First Generic Drug Approvals
08 Mar 2024 22:36 GMT
… Package
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Gadavist (Gadobutro) Injection
… Bulk Package
B. Braun Medical, Inc.
Calcium Gluconate in … , once-daily, maintenance treatment of bronchospasm associated with … refractory to other drugs
18
213267
Thalidomide …
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La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias
25 Aug 2023 18:20 GMT
… de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas … de Dotarem (gadoterato de meglumina), Gadavist (gadobutrol) y ProHance (gadoteridol); … Macrocíclica
Eovist
gadoxetato disódico
Lineal
Gadavist†
gadobutrol
Macrocíclica
Magnevist
gadopentetato …
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Generic substitute for gadolinium-based contrast agent Gadavist hits the market
10 Aug 2023 01:26 GMT
According to a prepared statement from Fresenius Kabi, Gadobutrol Injection is indicated to help detect and visualize areas with a disrupted blood brain barrier, assess the presence of malignant breast disease, evaluate suspected supra-aortic or renal …
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PROMISE trial results reinforce confidence in new MRI contrast agent
20 Jul 2023 23:45 GMT
… 1 mmol/kg gadobutrol (Gadavist) when used during various contrast … blinded readers involved in the trial.
The majority of readers expressed … approved by the U.S. FDA for use in adults and … ),” Renoldi Bracco said.
The trial’s results were published July …
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FDA approves Bayer’s Ultravist® (iopromide) injection for contrast-enhanced mammography
23 Jun 2023 17:30 GMT
… S. Food and Drug Administration (FDA) for contrast- … , prematurity, underlying medical conditions affecting thyroid function … have measures for treatment of a hypertensive … occurred following Gadavist® administration. Before Gadavist® administration, assess …
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2022 First Generic Drug Approvals
03 Mar 2023 17:52 GMT
… Vial
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Gadavist (Gadobutrol) Injection
… therapy to antidepressants for the treatment of major … /mL)
Indoco Remedies Limited
Vimpat (Lacosamide) … partial reversal of opioid drug effects, including respiratory …
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Preeminent Hospitals and Medical Practices Nationwide Lead in Patient Care with First Use of Bracco's VUEWAY™ (gadopiclenol) solution for injection for MRI
14 Feb 2023 20:57 GMT
… available for the treatment of hypersensitivity reactions … prescription drugs to the FDA. Visit www.fda.gov … ), and Nuclear Medicine through radioactive tracers … GADAVIST® (gadobutrol) Injection. Full Prescribing Information. Bayer HealthCare Pharmaceuticals …
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April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
10 Feb 2023 08:45 GMT
… labels that contribute to wrong drug errors
FDA is evaluating the need …
Elucirem (gadopiclenol)
Eovist (gadoxetate disodium)
Gadavist (gadobutrol)
MultiHance (gadobenate dimeglumine)
MultiHance … that contribute to wrong drug errors
FDA is evaluating the need …