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Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002438-PIP02-19-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 08/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002311-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002232-PIP02-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cotadutide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002287-PIP01-17-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001930-PIP01-16-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 29/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001856-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate, vaborbactam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001731-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: P/13/2010, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 22/01/2010, Last updated: 12/07/2022, Compliance check: V, 16/04/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene
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-001933-PIP01-16-M01, Route(s) of administration: Intraosseous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 12/06/2020, Last updated: 01/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Isavuconazonium sulfate
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-001301-PIP01-12, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 14/06/2013, Last updated: 29/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 27/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001540-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/07/2016, Last updated: 16/06/2022, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871)
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-002414-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/08/2019, Last updated: 16/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tabalumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000802-PIP02-11-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 27/10/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)
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-000635-PIP01-09, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/02/2010, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Insulin peglispro
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001097-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human heparan-N-sulfatase
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-001634-PIP01-14, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 30/01/2015, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Methyl aminolevulinate hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000698-PIP02-10-M01, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 06/05/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate
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-001748-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/01/2021, Last updated: 10/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001501-PIP04-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 10/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deleobuvir
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-001389-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 24/09/2013, Last updated: 09/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Selonsertib
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-001868-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/09/2017, Last updated: 07/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254, recombinant neisseria meningitis group B Protein 936-741, meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein, recombinant neisseria meningitis group B Protein 287-953, recombinant neisseria meningitis group B Protein 961c, meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001260-PIP01-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension for injection
Decision date: 19/06/2020, Last updated: 31/05/2022, Compliance check: X