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Human medicines European public assessment report (EPAR): Sugammadex Fresenius Kabi, sugammadex, Date of authorisation: 15/07/2022, Revision: 1, Status: Authorised
25 Mar 2025 22:54 GMT
… supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Fresenius … package leaflet or contact your doctor or pharmacist.
How does Sugammadex … carried out with the reference medicine, Bridion, and do not need to …
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January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
05 Mar 2025 21:57 GMT
… to include coronary spasm.
Bridion labeling
Bydureon (exenatide … Counseling Information,” and “Medication Guide,” sections of the …
Methylphenidate
Methylphenidate hydrochloride
Drug interaction between CNS …
Example: Inlyta labeling
FDA determined that no …
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Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December
16 Dec 2024 19:21 GMT
… vaccine, was also recommended for the prevention of COVID-19.
Orphan drugs … for several drugs, including Ofev for the treatment of … children and adolescents, Blincyto, Bridion, Flucelvax Tetra, Jemperli, Omvoh … the Committee for Medicinal Products for Human …
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024
13 Dec 2024 14:06 GMT
… a self-amplifying mRNA vaccine intended for the prevention … clinical tests and clinical trials of an already … six biosimilar medicines:
Avtozma (tocilizumab), for the treatment of rheumatoid … medicines that are already authorised in the EU: Blincyto*, Bridion …
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Summary of opinion: Bridion, 12/12/2024 Positive
13 Dec 2024 14:15 GMT
… the marketing authorisation for the medicinal product Bridion. The marketing authorisation holder … for this medicinal product is Merck … information, the full indications for Bridion will be as follows:
Reversal …
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Human medicines European public assessment report (EPAR): Sugammadex Amomed, sugammadex, Date of authorisation: 10/01/2023, Revision: 3, Status: Authorised
23 Sep 2024 15:33 GMT
… supervision of an anaesthetist (a doctor specialised in anaesthesia). Sugammadex Amomed … package leaflet or contact your doctor or pharmacist.
How does Sugammadex … carried out with the reference medicine, Bridion, and do not need to …
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Federal Circuit Decision Could Encourage More Reissue Patents
25 Mar 2025 02:55 GMT
… the active ingredient of BRIDION®.
Merck applied for FDA approval of sugammadex … ,” stating:
[T]he purpose of [§ 156] is clear: to compensate pharmaceutical companies … for regulatory approval of new drug applications.
With this purpose in …
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Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)
24 Mar 2025 19:56 GMT
… ingredient in Merck's Bridion drug, which is used to … for the delay in obtaining FDA approval," citing Merck … intent to "compensate pharmaceutical companies for the effective truncation … " (emphasis added) (stating this is "the most …
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Federal Circuit: Reissue Patents Get PTE Based on the Original Patent’s Issue Date
20 Mar 2025 15:27 GMT
… related to Merck’s Bridion®, a drug with the active ingredient … to the Food and Drug Administration (“FDA”) for approval of … cases were consolidated.
At trial, Aurobindo argued that based … Act: “to compensate the pharmaceutical companies for the effective …
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Patent Case Summaries | Week Ending March 14, 2025
19 Mar 2025 05:06 GMT
… appealed to the Patent Trial and Appeal Board, and … specification did not limit the treatment to any specific disease, … ingredient in Merck’s drug BRIDION®.
Merck then filed a …
View Opinion
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al …