Swedish Orphan Biovitrum publ AB: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
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EMA Validates Swedish Orphan Biovitrum publ AB's Application for Orfadin Oral Suspension
Swedish Orphan Biovitrum publ AB announced that its application for Orfadin oral suspension has been validated by the European Medicines Agency (EMA). This new dosage form has been developed to facilitate the ease and accuracy in administration of the desired Orfadin dose to pediatric patients and to increase convenience for the patients and their caregivers. The oral suspension is included in a Pediatric Investigation Plan (PIP) agreed with EMA in March 2012.
Latest Developments for Swedish Orphan Biovitrum publ AB
- FDA approves Swedish Orphan Biovitrum and Biogen Idec Eloctate
- Swedish Orphan Biovitrum elects Ernst & Young as auditor
- Swedish Orphan Biovitrum and Biogen Idec announce positive efficacy and safety results from phase-3 paediatric study of investigational therapy Eloctate for haemophilia A
- Swedish Orphan Biovitrum publ AB announces FDA approval of Alprolix
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