New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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Mithra says its new oral contraceptive could be a major breakthrough in a “space where there hasn’t been any innovation in decades."
The opioid, which has been used as a cough suppressant since the 1950s, should no longer be marketed, according to a safety review by the European Medicines Agency.
The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.