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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311) (updated)
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): Doptelet, avatrombopag maleate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 22/11/2019, Last updated: 12/01/2021, 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%) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000860-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000857-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Betula pendula (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000853-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Betula pendula (33%), Corylus avellana (33%) and Alnus glutinosa (33%) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000852-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, 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): tilmanocept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-001255-PIP01-11-M03, Route(s) of administration: Intradermal use, Subcutaneous use, Intratumoral use, Peritumoural use, Intralymphatic use, Interstitial use, Pharmaceutical form(s): Kit for radiopharmaceutical preparation
Decision date: 11/04/2018, Last updated: 10/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Meropenem trihydrate (in combination with vaborbactam)
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-001731-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 12/10/2020, 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: Capsule, hard, Age-appropriate oral dosage form, Pharmaceutical form(s): Oral use
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): Invokana, canagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001030-PIP01-10-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/08/2017, 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): Fevipiprant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001315-PIP02-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Chewable tablet, Age-appropriate oral liquid dosage form
Decision date: 10/09/2019, Last updated: 20/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Captopril
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-001544-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 08/08/2014, Last updated: 11/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Eladocagene exuparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002435-PIP01-18-M01, Route(s) of administration: Intracerebral use, Intracerebroventricular use, Intracisternal use, Intrathecal use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002298-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, meloxicam (HTX-011)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-002246-PIP01-17-M01, Route(s) of administration: Application to surgical site, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002070-PIP01-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002031-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 20/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 04/01/2019, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Avacopan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002023-PIP01-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Decision date: 20/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vadadustat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001944-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral formulation
Decision date: 21/03/2020, Last updated: 04/08/2020, Compliance check: X