| Document Date: 2011-06-06 13:39:08
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City Sublimaze / / Company Cephalon / Johnson & Johnson Jansen-Cilag Oy / Janssen Pharmaceutical / / Country Germany / Norway / Belgium / France / Japan / United States / Netherlands / United Kingdom / Ireland / / Event Person Communication and Meetings / FDA Phase / Product Recall / Product Issues / / Facility Durogesic Sublimaze ACTIQ INN / / IndustryTerm pharmaceutical formulation / treatment of cancer / medicinal product / medicinal products / therapy for their underlying persistent cancer / / MedicalCondition cancer / severe chronic pain / chronic pain / non-cancer breakthrough pain / patent ductus arteriosus / persistent cancer / nausea / non-malignant chronic intractable pain / pain / vomiting / breakthrough pain / respiratory depression / Indication(s) Breakthrough Pain / breakthrough cancer pain / opioid withdrawal syndrome / MS / / MedicalTreatment Premedication / cardiac surgery / surgery / / Organization MHRA / US Food and Drug Administration / Intravenous administration / Intramuscular administration / European Union / / Person Johnson Johnson / / Position EXECUTIVE / expert paediatric anaesthetist / Fisher / / Product Sublimaze Injection / Fentanyl Citrate / syndrome / ACTIQ / Ionsys / Fentanyl / EU / Sublimaze / / Technology Pharmacokinetics / /
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Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended