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644 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
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PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) 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): Lonafarnib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002516-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/07/2019, Last updated: 20/09/2021, Compliance check: V, 27/03/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): glucarpidase
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-001391-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 30/07/2013, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonapegsomatropin
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-002692-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 15/07/2020, Last updated: 16/09/2021, Compliance check: X, 04/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir
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-001904-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 16/11/2018, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002559-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002266-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/09/2018, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bulevirtide
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-002399-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 26/08/2019, Last updated: 30/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpha tocotrienol quinone
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-001238-PIP01-12, Route(s) of administration: Oral use, Enteral use, Pharmaceutical form(s): Oral solution
Decision date: 30/07/2013, Last updated: 07/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
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-001015-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 09/06/2011, Last updated: 21/04/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Factor VIII Fc - von Willebrand factor - XTEN fusion protein (rFVIIIFc-VWF-XTEN)
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-002501-PIP01-18-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for 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): eptinezumab
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-002243-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
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): Brazikumab
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-001929-PIP01-16, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 19/12/2017, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium
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-002214-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 21/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)
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-001314-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 07/04/2014, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 24/04/2009, Last updated: 26/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Molidustat (sodium)
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-001546-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 27/10/2014, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fremanezumab
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-001877-PIP03-17, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
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-002398-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard
Decision date: 17/05/2019, Last updated: 12/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647)
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-002218-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 07/10/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Norovirus GI.1 virus-like particle antigen, norovirus GII.4 virus-like particle antigen
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-001609-PIP01-14, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 05/06/2015, Last updated: 29/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Yamagata lineage)
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-001894-PIP01-15-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/11/2016, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001732-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 04/11/2016, Last updated: 07/08/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)
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-002057-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 04/10/2017, Last updated: 27/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline
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-000275-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for injection
Decision date: 18/05/2009, Last updated: 08/03/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
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-001684-PIP01-14, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 02/10/2015, Last updated: 07/03/2019, Compliance check: V, 21/04/2017