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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Psychiatry
PIP number: EMEA-002222-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant tablet
Decision date: 08/11/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000744-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eperzan, Albiglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001175-PIP01-11-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/10/2016, Last updated: 19/02/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): misoprostol
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-001601-PIP01-13, Route(s) of administration: Oral use, Sublingual use, Vaginal use, Pharmaceutical form(s): Tablet
Decision date: 05/06/2015, Last updated: 02/09/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Netarsudil, Latanoprost
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002175-PIP01-17, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Risperidone
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001034-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/07/2011, Last updated: 09/08/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alnus glutinosa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000906-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 03/12/2010, Last updated: 11/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)
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-001430-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 02/04/2014, Last updated: 07/12/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human granulocyte colony stimulating factor coupled with recombinant human albumin fusion protein
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001042-PIP02-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Testosterone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Testosterone, Route(s) of administration: Transdermal use, Pharmaceutical form(s): Transdermal patch
Decision date: 11/08/2009, Last updated: 22/10/2009, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): anifrolumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001435-PIP02-16-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gevokizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-001487-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/06/2014, Last updated: 02/10/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Delafloxacin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001080-PIP01-10, Route(s) of administration: Intravenous use Oral Use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): grass pollen, cereal pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000964-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001942-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/08/2016, Last updated: 28/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002024-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 31/01/2017, Last updated: 17/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): telmisartan, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000045-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/02/2008, Last updated: 15/02/2008, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): rye pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000943-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000156-PIP01-07-M02, Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2011, Last updated: 08/04/2011, Compliance check: V, 17/01/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): exenatide
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-001755-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Implant
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flibanserin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000085-PIP01-07, Route(s) of administration: Oral, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/04/2008, Last updated: 16/05/2008, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): grass pollen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000954-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: X