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39 results
Medicine
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W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Clindamycin phosphate, Tretinoin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-000892-PIP01-10, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 27/08/2010, Last updated: 06/10/2010, Compliance check: V, 10/12/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Buccolam, Midazolam Hydrochloride
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-000395-PIP01-08, Route(s) of administration: Oromucosal use, Pharmaceutical form(s): Oromucosal solution
Decision date: 11/08/2009, Last updated: 22/10/2009, Compliance check: V, 06/08/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lantus, insulin glargine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Insulin glargine, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Solution for injection in a vial, Solution for injection in a cartridge
Decision date: 15/07/2009, Last updated: 16/09/2009, Compliance check: V, 18/11/2011 -
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Opinion/decision on a Paediatric investigation plan (PIP): Toujeo (previously Optisulin), insulin glargine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Insulin glargine, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Solution for injection in a vial, Solution for injection in a cartridge
Decision date: 15/07/2009, Last updated: 16/09/2009, Compliance check: V, 18/11/2011 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cholestagel, Colesevelam hydrochloride
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Colesevelam hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/06/2009, Last updated: 11/08/2009, Compliance check: V, 24/07/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Orencia, Abatacept
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000118-PIP01-07-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 19/05/2009, Last updated: 09/07/2009, Compliance check: V, 29/05/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): purified diphtheria toxoid, Purified Tetanus Toxoid, Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)], Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett), Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-000278-PIP01-08-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe, Suspension for injection in a vial
Decision date: 31/03/2009, Last updated: 18/05/2009, Compliance check: V, 18/09/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Anastrozole
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Anastrozole, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 06/02/2009, Last updated: 23/04/2009, Compliance check: V, 03/04/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): ViraferonPeg, peginterferon alfa-2b
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000384-PIP01-08, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection in vial and in pre-filled pen
Decision date: 14/10/2008, Last updated: 24/11/2008, Compliance check: V, 17/10/2008 -
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Opinion/decision on a Paediatric investigation plan (PIP): PegIntron, peginterferon alfa-2b
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000071-PIP01-07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection in vial and in pre-filled pen
Decision date: 15/08/2008, Last updated: 18/09/2008, Compliance check: V, 17/10/2008 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rebetol, Ribavirin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: Ribavirin, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution and Hard Capsules
Decision date: 15/08/2008, Last updated: 18/09/2008, Compliance check: V, 17/10/2008 -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Atorvastatin calcium, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: V, 13/11/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zometa, zoledronic acid
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000024-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Concentrate for solution for infusion
Decision date: 24/06/2008, Last updated: 21/07/2008, Compliance check: V, 12/12/2008 -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000008-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009