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  1. The national medicine registers in the different Member States of the European Union (EU) and European Economic Area (EEA) contain information on medicines authorised in those countries, including links for the summary of product characteristics (SmPC) and the package leaflet.

  2. Approved Marketing Authorisations (MA) containing Acetavance in Europe. Original Data : EMA Website

  3. Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein. Follow the journey of a medicine for human use assessed by EMA in this interactive timeline.

  4. Ofirmev FDA Approval History. FDA Approved: Yes (Discontinued) (First approved November 2, 2010) Brand name: Ofirmev Generic name: acetaminophen Dosage form: Intravenous Injection Previous Name: Acetavance Company: Cadence Pharmaceuticals, Inc. Treatment for: Pain, Fever

  5. Acetaminophen Injection for Intravenous Use (ACETAVANCETM), subject of NDA22450, was developed by Cadence Pharmaceuticals, Inc. for the treatment of acute pain and fever in adults and pediatric...

  6. List of Approved Drug Products containing Acetavance in the FDA Orange Book on PharmaCompass.com

  7. To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the specific form and accompanied by a justification.

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