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Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl citrate
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Pain
PIP number: Fentanyl citrate, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, Solution
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: Xhttp://www.emea.europa.eu Doc. Ref. EMA/749288/2009 P/258/2009 … http://www.emea.europa.eu Doc. Ref. EMEA/PDCO/705150/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Live bacterium B. thetaiotaomicron
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Gastroentology-Hepatology
PIP number: Live bacterium B. thetaiotaomicron, Route(s) of administration: Oral use, Pharmaceutical form(s): Live Bacteria in an Enteric Coated Capsule
Decision date: 21/08/2009, Last updated: 22/10/2009, Compliance check: Xhttp://www.emea.europa.eu Doc. Ref. EMEA/494847/2009 P/166/2009 … http://www.emea.europa.eu Doc. Ref. EMEA/PDCO/403424/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: Xhttp://www.emea.europa.eu Doc. Ref. EMEA/96351/2009 P/22/2009 … http://www.emea.europa.eu Doc. Ref. EMEA/PDCO/73749/2009 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Cardiovascular diseases
PIP number: Candesartan cilexetil, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Suspension for oral use
Decision date: 20/02/2009, Last updated: 23/04/2009, Compliance check: Xhttp://www.emea.europa.eu Doc. Ref. EMEA/95694/2009 P/21/2009 … http://www.emea.europa.eu Doc. Ref. EMEA/PDCO/64696/2009 …