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October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
31 Mar 2025 19:52 GMT
… or more antidepressant(s)
Discontinuation-emergent cataplexy
FDA is evaluating … regulatory action.
Cellcept (mycophenolate mofetil) capsules; tablets
Cellcept Intravenous (mycophenolate … about hepatotoxicity.
An FDA Drug Safety Communication was issued …
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CellCept and pregnancy, breastfeeding, and birth control
21 Mar 2025 19:51 GMT
… your CellCept treatment. They … pills, talk with your doctor before taking CellCept. Your doctor … can determine whether you’re taking a birth control pill … doctor or another healthcare professional before taking any medication. The drug …
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Advancements in Myasthenia Gravis Treatment
05 Feb 2025 17:16 GMT
… treatment options available, including the recent FDA-approved drugs … efficacy in clinical trials, offering hope for … symptoms, ensuring accurate medication administration, and … GA: Sebela Pharmaceuticals Inc; 2018.
23. CellCept (mycophenolate mofetil) …
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Trethera To Participate in Panel Discussion and Research Poster Competition At Los Angeles Bioscience Ecosystem Summit 2025
22 Apr 2025 12:57 GMT
… the world’s leading pharmaceutical companies, venture capital … during autoimmune diseases. FDA approved drugs blocking the de … Mavenclad (cladribine), and CellCept (mycophenolate mofetil). About Trethera … development of novel treatments for autoimmune diseases …
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
15 Nov 2024 16:01 GMT
… Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents … for 11 medicines that are already authorised in the EU: CellCept, Evkeeza … /
cacao), a medicine intended for the treatment of moderate-to-severe …
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Summary of opinion: CellCept, 14/11/2024 Positive
15 Nov 2024 16:03 GMT
… the marketing authorisation for the medicinal product CellCept.
The marketing authorisation holder … for this medicinal product is Roche … include treatment of children from 1 year of age with CellCept 500 …
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ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter
15 Nov 2024 22:16 GMT
Approval Date
Reference Listed Drug
Generic Drug Name
NDA Holder
…
Endari
L-Glutamine
Emmaus Medical
Novitium Pharma
215647
07…
Tarceva
Erlotinib HCl
OSI Pharmaceuticals
Hikma
203843
09… 47;26/2024
Cellcept
Mycophenolate Mofetil
Roche Palo
Aurobindo …
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CellCept and cost
01 Nov 2024 13:15 GMT
… and your doctor will discuss CellCept in regard to your treatment. The insurance … your doctor or another healthcare professional before taking any medication. The drug information …
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Dexilant interactions: Alcohol, medications, and other factors
24 Oct 2024 12:53 GMT
… of methotrexate
mycophenolate mofetil (CellCept)
—
can make … recommend temporarily stopping treatment with Dexilant until you … been enough clinical trials to determine whether … doctor or another healthcare professional before taking any medication. The drug …
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Myasthenia Gravis Is the Disease. FcRn Is the Target
11 Apr 2025 06:15 GMT
… under the brand names CellCept, Myfortic and Myhibbin.
… FDA approved Alexion’s Soliris (eculizumab), the first medication … Pharmaceuticals. The investigational FcRn blocker is being developed for the treatment … treatment is currently in a phase 2 trial of …
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