European Pharmaceutical Review
NOVEMBER 13, 2023
The pharmaceutical company also highlighted that the decision was additionally supported by data from a subpopulation of adult patients with moderate to severe anaemia from the SIMPLIFY-1 Phase III trial. GSK shared that a decision on marketing authorisation for momelotinib in the EU is expected by early 2024.
Hospital Pharmacy Europe
NOVEMBER 9, 2023
It also allows pharmaceutical companies to monitor product information and keep it constantly updated, as well as offering healthcare professionals and patients greater accessibility. Pharmaceutical companies participating in the pilot create and submit the ePI via the PLM Portal as part of their regulatory application.
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European Pharmaceutical Review
SEPTEMBER 2, 2022
This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).
pharmaphorum
MAY 12, 2022
The software can be used to conduct an initial analysis of adverse reactions to medications that have already been approved to identify potential side effects and undesirable events, and provides a decision-making tool for those working in pharmacovigilance, helping them process each case more quickly.
Digital Pharmacist
OCTOBER 24, 2022
When it comes to innovation in the development of new drugs and therapeutic biological products in the pharmaceutical industry, the United States Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) is a key supporter of the pharmaceutical industry. . Date of Approval: 9/21/2022.
The Checkup by Singlecare
APRIL 30, 2024
Ozempic is made by the pharmaceutical company Novo Nordisk. People with symptoms of an allergic reaction should get emergency medical help. Currently, Ozempic is FDA-approved for adults with Type 2 diabetes. Many people lose weight while taking Ozempic, and the medication is often prescribed off-label as a weight loss drug.
The People's Pharmacy
JUNE 12, 2023
The parties that benefit are the pharmaceutical companies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. Should the Law Be Changed?
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