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Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001539-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 03/12/2021, Last updated: 01/02/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec) (updated)
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-002571-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 14/08/2020, Last updated: 31/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Selumetinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001585-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard
Decision date: 12/08/2021, Last updated: 24/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001974-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 26/11/2018, Last updated: 24/01/2023, 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: 16/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-infiltrating lymphocytes (LN-144/LN-145) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002776-PIP01-20-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Retsevmo, Selpercatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002544-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form
Decision date: 30/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Narsoplimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002479-PIP01-18-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Berotralstat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002449-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid formulation
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fidanacogene elaparvovec (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002362-PIP02-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002330-PIP01-18-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002319-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion, Age-appropriate dosage form for parenteral use
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Aztreonam (ATM), Avibactam (AVI) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002283-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dasiglucagon (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002233-PIP01-17-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Solriamfetol (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002184-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant Clostridioides difficile toxoid A, Recombinant Clostridioides difficile toxoid B (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002112-PIP01-16-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozlytrek, Entrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Avalglucosidase alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001945-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Naldemedine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001893-PIP01-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Enerzair Breezhaler, Indacaterol (acetate), Mometasone (furoate) (QVM149), glycopyrronium bromide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001812-PIP01-15-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Capsule, hard
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001720-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Metreleptin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001701-PIP01-14-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin (updated)
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-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: X