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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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2023 First Generic Drug Approvals
08 Mar 2024 22:36 GMT
… Package
B. Braun Medical, Inc.
Calcium Gluconate … once-daily, maintenance treatment of bronchospasm associated …
Aspiro Pharma Limited
Bridion (Sugammadex) Injection
6 … 0.064%
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited
Enstilar ( …
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Merck’s Bridion Could Face Generic Pressure from Hikma Ahead of Patent Expiry Date
27 Feb 2024 13:37 GMT
… Monday that Hikma Pharmaceuticals U.S. is seeking the FDA’s approval … relaxant reversal injection Bridion (sugammadex) prior to the drug’s patent expiration … new and innovative treatments to patients with unmet medical needs.
Tristan Manalac …
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The biotech $100-billion Club: Meet the 14 most valuable drug makers
05 Mar 2024 23:47 GMT
… S. Food and Drug Administration (FDA) for the treatment of one-year- … -drug conjugates for cancer, among others.
Vertex Pharmaceuticals – $112 billion
The American biotech … , Bridion, Adempas, Lagevrio, Belsomra, Simponi, and Januvia, as well as vaccines such …
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Merck's Bridion faces generic threat from drugmaker Hikma
26 Feb 2024 23:13 GMT
… received a letter that Hikma Pharmaceuticals US unit has sought … FDA to sell a generic version of its Bridion injection, the drugmaker … related to the brand-name drug.
Merck said in the … to Reuters requests for comment. Bridion, chemically known as sugammadex, …