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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: 24/11/2016, 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): 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): 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): Allergen extract of Alnus glutinosa 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-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): Aqueous allergen extract of grass and 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): telmisartan, ramipril (fixed combination)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Telmisartan / ramipril (fixed combination), 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): 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): 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: Flibanserin, 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): ciclosporin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001998-PIP01-16, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, emulsion
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)
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-000841-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cadazolid
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001108-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 15/07/2016, Last updated: 08/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Modified allergen extract of Dermatophagoides pteronyssinus
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-000935-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 26/01/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 17 beta-estradiol, etonogestrel
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-001718-PIP01-14, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lidocaine hydrochloride, Phenylephrine hydrochloride, Tropicamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000991-PIP01-10, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 26/10/2010, Last updated: 25/11/2010, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fostemsavir (tromethamine)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001687-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 29/01/2019, Last updated: 29/04/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (GSK1278863)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001452-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution, Oral suspension, Tablet
Decision date: 30/01/2018, Last updated: 18/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Allergen extracts of Dermatophagoides farinae and Dermatophagoides pteronyssinus (each 50%)
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-000866-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/01/2011, Last updated: 07/02/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Baclofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Psychiatry
PIP number: EMEA-001549-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2017, Last updated: 21/04/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nicotinic acid and laropiprant
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: Nicotinic acid and laropiprant, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 23/06/2008, Last updated: 21/07/2008, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxycodone (hydrochloride), naloxone (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001700-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 06/03/2015, Last updated: 06/07/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entospletinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002058-PIP01-16, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: X