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795 results
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 06/05/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Setmelanotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M04, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension
Decision date: 09/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001943-PIP01-16-M06, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit), Paullinia cupana Kunth, Theobroma cacao L.
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001835-PIP01-15-M05, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 09/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynquista, Sotagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001517-PIP02-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Film-coated tablet
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001407-PIP02-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 14/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000927-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu, Oseltamivir (phosphate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000365-PIP01-08-M12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Powder for oral suspension
Decision date: 25/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pevonedistat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002117-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 08/09/2021, Last updated: 25/03/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001975-PIP01-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 03/01/2019, Last updated: 24/03/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pegcetacoplan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002600-PIP01-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): dostarlimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002463-PIP01-18-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cipaglucosidase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002447-PIP01-18-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosilate monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age appropriate oral liquid formulation
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynrelef, 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-M02, Route(s) of administration: Application to surgical site, Pharmaceutical form(s): Solution for injection
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002205-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, 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-M05, 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: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Byfavo, Remimazolam (as besilate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Anaesthesiology
PIP number: EMEA-001880-PIP02-19-M02, Route(s) of administration: Intravenous use, Buccal use, Pharmaceutical form(s): Powder for solution for injection or infusion, Orodispersible film, Age-appropriate formulation
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract (Betula verrucosa)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001879-PIP01-15-M03, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral lyophilisate
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pegunigalsidase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001828-PIP01-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X