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42 results
Medicine type
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Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
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Categories
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PIP decision type
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
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
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
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP01-17-M03, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 08/07/2022, Last updated: 23/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Exviera, Dasabuvir (sodium monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001439-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid formulation
Decision date: 12/08/2020, Last updated: 28/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP02-17-M01, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 12/06/2019, Last updated: 08/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001448-PIP01-13-M03, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2012, Last updated: 02/03/2018, Compliance check: V, 02/06/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/10/2014, Last updated: 02/03/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
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-000876-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001272-PIP02-13-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for suspension for injection, Powder for solution for infusion
Decision date: 02/10/2015, Last updated: 23/11/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imvanex, Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001161-PIP02-11-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 13/07/2022, Last updated: 26/03/2012, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X