Paediatric investigation planshttps://www.ema.europa.eu/en/homepagePaediatric investigation plansen-gbCopyright: (C) European Medicines AgencyWed, 17 Jul 2024 12:34:41 +0200Tue, 16 Jul 2024 14:30:31 +0200EMEA-003413-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003413-pip01-23EMEA-003413-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003413-pip01-23Tue, 16 Jul 2024 14:30:31 +0200Paediatric investigation plansEMEA-003412-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003412-pip01-23EMEA-003412-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003412-pip01-23Tue, 16 Jul 2024 14:26:37 +0200Paediatric investigation plansEMEA-003410-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003410-pip01-23EMEA-003410-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003410-pip01-23Tue, 16 Jul 2024 14:21:59 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Ongentys, opicapone, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neurology, PIP number: P/0260/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003406-pip01-23Opinion/decision on a Paediatric investigation plan (PIP): Ongentys, opicapone, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Neurology, PIP number: P/0260/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003406-pip01-23Tue, 16 Jul 2024 14:19:59 +0200Paediatric investigation plansEMEA-003403-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003403-pip01-23EMEA-003403-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003403-pip01-23Tue, 16 Jul 2024 14:17:32 +0200Paediatric investigation plansEMEA-003367-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003367-pip01-22EMEA-003367-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003367-pip01-22Tue, 16 Jul 2024 14:14:11 +0200Paediatric investigation plansEMEA-003324-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003324-pip01-22EMEA-003324-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003324-pip01-22Tue, 16 Jul 2024 14:11:51 +0200Paediatric investigation plansEMEA-003409-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003409-pip01-23EMEA-003409-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003409-pip01-23Tue, 16 Jul 2024 14:07:47 +0200Paediatric investigation plansEMEA-003325-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003325-pip01-22EMEA-003325-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003325-pip01-22Tue, 16 Jul 2024 14:02:50 +0200Paediatric investigation plansEMEA-003422-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003422-pip01-23EMEA-003422-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003422-pip01-23Tue, 16 Jul 2024 13:59:55 +0200Paediatric investigation plansEMEA-003318-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003318-pip01-22EMEA-003318-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003318-pip01-22Tue, 16 Jul 2024 13:56:56 +0200Paediatric investigation plansEMEA-003314-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003314-pip01-22EMEA-003314-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003314-pip01-22Tue, 16 Jul 2024 13:47:24 +0200Paediatric investigation plansEMEA-003276-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003276-pip01-22EMEA-003276-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003276-pip01-22Tue, 16 Jul 2024 13:43:12 +0200Paediatric investigation plansEMEA-003267-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003267-pip02-23EMEA-003267-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003267-pip02-23Tue, 16 Jul 2024 13:38:15 +0200Paediatric investigation plansEMEA-003263-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003263-pip01-22EMEA-003263-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003263-pip01-22Tue, 16 Jul 2024 13:34:52 +0200Paediatric investigation plansEMEA-003055-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003055-pip02-23EMEA-003055-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003055-pip02-23Tue, 16 Jul 2024 13:31:02 +0200Paediatric investigation plansEMEA-003268-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003268-pip01-22EMEA-003268-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003268-pip01-22Mon, 15 Jul 2024 17:52:52 +0200Paediatric investigation plansEMEA-003270-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003270-pip01-22EMEA-003270-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003270-pip01-22Mon, 15 Jul 2024 17:48:32 +0200Paediatric investigation plansEMEA-003019-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003019-pip01-21EMEA-003019-PIP01-21https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003019-pip01-21Mon, 15 Jul 2024 17:44:42 +0200Paediatric investigation plansEMEA-002908-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002908-pip02-22EMEA-002908-PIP02-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002908-pip02-22Mon, 15 Jul 2024 17:38:39 +0200Paediatric investigation plansEMEA-002559-PIP08-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002559-pip08-23EMEA-002559-PIP08-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002559-pip08-23Mon, 15 Jul 2024 17:32:50 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Spevigo, Spesolimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0247/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002475-pip03-22Opinion/decision on a Paediatric investigation plan (PIP): Spevigo, Spesolimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0247/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002475-pip03-22Mon, 15 Jul 2024 17:26:53 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Sotyktu, Deucravacitinib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0250/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002350-pip05-23Opinion/decision on a Paediatric investigation plan (PIP): Sotyktu, Deucravacitinib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0250/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002350-pip05-23Fri, 12 Jul 2024 17:20:28 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0282/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip11-23Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0282/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip11-23Fri, 12 Jul 2024 17:16:13 +0200Paediatric investigation plansEMEA-002886-PIP01-20-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002886-pip01-20-m03EMEA-002886-PIP01-20-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002886-pip01-20-m03Fri, 12 Jul 2024 16:00:00 +0200Paediatric investigation plansEMEA-002819-PIP01-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002819-pip01-20-m01EMEA-002819-PIP01-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002819-pip01-20-m01Fri, 12 Jul 2024 15:57:00 +0200Paediatric investigation plansEMEA-002631-PIP01-19-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002631-pip01-19-m02EMEA-002631-PIP01-19-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002631-pip01-19-m02Fri, 12 Jul 2024 15:55:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Vyvgart, Efgartigimod alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0252/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip04-21-m01Opinion/decision on a Paediatric investigation plan (PIP): Vyvgart, Efgartigimod alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0252/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip04-21-m01Fri, 12 Jul 2024 15:49:00 +0200Paediatric investigation plansEMEA-002572-PIP02-19-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002572-pip02-19-m03EMEA-002572-PIP02-19-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002572-pip02-19-m03Fri, 12 Jul 2024 15:46:00 +0200Paediatric investigation plansEMEA-002472-PIP03-22-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002472-pip03-22-m01EMEA-002472-PIP03-22-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002472-pip03-22-m01Fri, 12 Jul 2024 15:41:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Mounjaro, Tirzepatide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0285/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002360-pip02-22-m01Opinion/decision on a Paediatric investigation plan (PIP): Mounjaro, Tirzepatide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0285/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002360-pip02-22-m01Fri, 12 Jul 2024 15:38:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0281/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002358-pip02-18-m03Opinion/decision on a Paediatric investigation plan (PIP): Ayvakyt, Avapritinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0281/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002358-pip02-18-m03Fri, 12 Jul 2024 15:34:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Prevenar 20 (previously Apexxnar), Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0246/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002330-pip01-18-m03Opinion/decision on a Paediatric investigation plan (PIP): Prevenar 20 (previously Apexxnar), Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0246/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002330-pip01-18-m03Fri, 12 Jul 2024 15:27:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Camzyos, Mavacamten, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0278/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002231-pip01-17-m01Opinion/decision on a Paediatric investigation plan (PIP): Camzyos, Mavacamten, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0278/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002231-pip01-17-m01Fri, 12 Jul 2024 15:21:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0267/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002064-pip01-16-m05Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: P/0267/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002064-pip01-16-m05Fri, 12 Jul 2024 15:13:00 +0200Paediatric investigation plansEMEA-001821-PIP01-15-M07https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001821-pip01-15-m07EMEA-001821-PIP01-15-M07https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001821-pip01-15-m07Fri, 12 Jul 2024 15:10:00 +0200Paediatric investigation plansEMEA-001624-PIP01-14-M06https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001624-pip01-14-m06EMEA-001624-PIP01-14-M06https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001624-pip01-14-m06Fri, 12 Jul 2024 15:05:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0276/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001526-pip01-13-m06Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0276/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001526-pip01-13-m06Fri, 12 Jul 2024 14:59:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0257/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001280-pip01-12-m06Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0257/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001280-pip01-12-m06Fri, 12 Jul 2024 14:49:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Imlygic, talimogene laherparepvec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0275/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001251-pip01-11-m06Opinion/decision on a Paediatric investigation plan (PIP): Imlygic, talimogene laherparepvec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0275/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001251-pip01-11-m06Fri, 12 Jul 2024 14:46:00 +0200Paediatric investigation plansOpinion/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: P/0284/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001161-pip02-11-m03Opinion/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: P/0284/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001161-pip02-11-m03Fri, 12 Jul 2024 14:44:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0049/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001050-pip02-18-m02Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0049/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001050-pip02-18-m02Fri, 12 Jul 2024 14:44:00 +0200Paediatric investigation plansOpinion/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: P/0258/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001045-pip01-10-m03Opinion/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: P/0258/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001045-pip01-10-m03Fri, 12 Jul 2024 14:40:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): onivyde, irinotecan, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0241/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003416-pip01-23Opinion/decision on a Paediatric investigation plan (PIP): onivyde, irinotecan, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0241/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003416-pip01-23Wed, 10 Jul 2024 14:12:38 +0200Paediatric investigation plansEMEA-003408-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003408-pip01-23EMEA-003408-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003408-pip01-23Wed, 10 Jul 2024 14:07:22 +0200Paediatric investigation plansEMEA-003398-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003398-pip01-23EMEA-003398-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003398-pip01-23Wed, 10 Jul 2024 14:00:16 +0200Paediatric investigation plansEMEA-003391-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003391-pip01-23EMEA-003391-PIP01-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003391-pip01-23Wed, 10 Jul 2024 13:56:47 +0200Paediatric investigation plansEMEA-003387-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003387-pip01-22EMEA-003387-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003387-pip01-22Wed, 10 Jul 2024 13:38:44 +0200Paediatric investigation plansEMEA-003384-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003384-pip02-23EMEA-003384-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003384-pip02-23Wed, 10 Jul 2024 13:34:12 +0200Paediatric investigation plansEMEA-003383-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003383-pip02-23EMEA-003383-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003383-pip02-23Wed, 10 Jul 2024 13:31:47 +0200Paediatric investigation plansEMEA-003349-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003349-pip01-22EMEA-003349-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003349-pip01-22Wed, 10 Jul 2024 13:27:13 +0200Paediatric investigation plansEMEA-003306-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003306-pip01-22EMEA-003306-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003306-pip01-22Wed, 10 Jul 2024 12:15:07 +0200Paediatric investigation plansEMEA-003296-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003296-pip01-22EMEA-003296-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003296-pip01-22Wed, 10 Jul 2024 12:11:02 +0200Paediatric investigation plansEMEA-003280-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003280-pip01-22EMEA-003280-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003280-pip01-22Wed, 10 Jul 2024 10:50:18 +0200Paediatric investigation plansEMEA-003264-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003264-pip01-22EMEA-003264-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003264-pip01-22Wed, 10 Jul 2024 10:41:35 +0200Paediatric investigation plansEMEA-003260-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003260-pip02-23EMEA-003260-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003260-pip02-23Wed, 10 Jul 2024 09:58:14 +0200Paediatric investigation plansEMEA-003247-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003247-pip02-23EMEA-003247-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003247-pip02-23Wed, 10 Jul 2024 09:53:56 +0200Paediatric investigation plansEMEA-003201-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003201-pip01-22EMEA-003201-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003201-pip01-22Wed, 10 Jul 2024 09:45:05 +0200Paediatric investigation plansEMEA-002619-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002619-pip02-23EMEA-002619-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002619-pip02-23Wed, 10 Jul 2024 09:40:04 +0200Paediatric investigation plansEMEA-002597-PIP08-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip08-22EMEA-002597-PIP08-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip08-22Wed, 10 Jul 2024 09:34:17 +0200Paediatric investigation plansEMEA-002052-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002052-pip02-23EMEA-002052-PIP02-23https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002052-pip02-23Fri, 05 Jul 2024 16:46:25 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0201/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip10-23Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0201/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000380-pip10-23Fri, 05 Jul 2024 16:29:18 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0238/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002961-pip01-21-m02Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0238/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002961-pip01-21-m02Fri, 05 Jul 2024 16:25:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0235/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002899-pip01-20-m02Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0235/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002899-pip01-20-m02Fri, 05 Jul 2024 16:23:00 +0200Paediatric investigation plansEMEA-002762-PIP02-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002762-pip02-20-m01EMEA-002762-PIP02-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002762-pip02-20-m01Fri, 05 Jul 2024 16:17:00 +0200Paediatric investigation plansEMEA-002735-PIP03-20-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002735-pip03-20-m02EMEA-002735-PIP03-20-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002735-pip03-20-m02Fri, 05 Jul 2024 16:11:00 +0200Paediatric investigation plansEMEA-002735-PIP01-19-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002735-pip01-19-m01EMEA-002735-PIP01-19-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002735-pip01-19-m01Fri, 05 Jul 2024 16:00:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Ontozry, cenobamate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0214/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002563-pip02-19-m02Opinion/decision on a Paediatric investigation plan (PIP): Ontozry, cenobamate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0214/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002563-pip02-19-m02Fri, 05 Jul 2024 15:46:00 +0200Paediatric investigation plansEMEA-002229-PIP02-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002229-pip02-21-m01EMEA-002229-PIP02-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002229-pip02-21-m01Fri, 05 Jul 2024 15:43:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Adtralza, Tralokinumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0186/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001900-pip02-17-m07Opinion/decision on a Paediatric investigation plan (PIP): Adtralza, Tralokinumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0186/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001900-pip02-17-m07Fri, 05 Jul 2024 15:40:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0242/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001766-pip01-15-m05Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0242/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001766-pip01-15-m05Fri, 05 Jul 2024 15:21:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0237/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip01-14-m06Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0237/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001741-pip01-14-m06Fri, 05 Jul 2024 15:07:00 +0200Paediatric investigation plansEMEA-001627-PIP01-14-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001627-pip01-14-m03EMEA-001627-PIP01-14-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001627-pip01-14-m03Fri, 05 Jul 2024 15:00:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Filsuvez, birch bark, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0243/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001299-pip03-17-m02Opinion/decision on a Paediatric investigation plan (PIP): Filsuvez, birch bark, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0243/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001299-pip03-17-m02Fri, 05 Jul 2024 14:59:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0202/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip01-11-m08Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0202/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001220-pip01-11-m08Fri, 05 Jul 2024 14:56:00 +0200Paediatric investigation plansEMEA-001150-PIP02-13-M05https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001150-pip02-13-m05EMEA-001150-PIP02-13-M05https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001150-pip02-13-m05Fri, 05 Jul 2024 14:53:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Kyntheum, brodalumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0212/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001089-pip02-13-m04Opinion/decision on a Paediatric investigation plan (PIP): Kyntheum, brodalumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0212/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001089-pip02-13-m04Fri, 05 Jul 2024 14:23:00 +0200Paediatric investigation plansEMEA-000902-PIP01-10-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000902-pip01-10-m01EMEA-000902-PIP01-10-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000902-pip01-10-m01Fri, 05 Jul 2024 14:19:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Ponvory, ponesimod, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology;Other, PIP number: P/0234/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000798-pip01-09-m04Opinion/decision on a Paediatric investigation plan (PIP): Ponvory, ponesimod, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology;Other, PIP number: P/0234/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000798-pip01-09-m04Fri, 05 Jul 2024 14:10:00 +0200Paediatric investigation plansEMEA-000551-PIP04-21-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000551-pip04-21-m02EMEA-000551-PIP04-21-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000551-pip04-21-m02Fri, 05 Jul 2024 14:07:00 +0200Paediatric investigation plansOpinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0200/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000468-pip02-12-m08Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0200/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000468-pip02-12-m08Fri, 05 Jul 2024 13:50:00 +0200Paediatric investigation plansEMEA-000347-PIP02-16-M05https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000347-pip02-16-m05EMEA-000347-PIP02-16-M05https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000347-pip02-16-m05Fri, 05 Jul 2024 13:47:00 +0200Paediatric investigation plansEMEA-000207-PIP01-08-M08https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000207-pip01-08-m08EMEA-000207-PIP01-08-M08https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000207-pip01-08-m08Fri, 05 Jul 2024 13:41:00 +0200Paediatric investigation plansEMEA-003149-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003149-pip01-21-m01EMEA-003149-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003149-pip01-21-m01Thu, 04 Jul 2024 15:05:00 +0200Paediatric investigation plansEMEA-003001-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003001-pip01-21-m01EMEA-003001-PIP01-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003001-pip01-21-m01Thu, 04 Jul 2024 15:00:00 +0200Paediatric investigation plansEMEA-002942-PIP02-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002942-pip02-20-m01EMEA-002942-PIP02-20-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002942-pip02-20-m01Thu, 04 Jul 2024 14:56:00 +0200Paediatric investigation plansEMEA-002935-PIP01-20-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002935-pip01-20-m03EMEA-002935-PIP01-20-M03https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002935-pip01-20-m03Thu, 04 Jul 2024 14:52:00 +0200Paediatric investigation plansEMEA-002443-PIP01-18-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002443-pip01-18-m02EMEA-002443-PIP01-18-M02https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002443-pip01-18-m02Thu, 04 Jul 2024 14:47:00 +0200Paediatric investigation plansEMEA-002705-PIP01-19-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002705-pip01-19-m01EMEA-002705-PIP01-19-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002705-pip01-19-m01Thu, 04 Jul 2024 14:43:00 +0200Paediatric investigation plansEMEA-002597-PIP05-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip05-21-m01EMEA-002597-PIP05-21-M01https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002597-pip05-21-m01Thu, 04 Jul 2024 14:36:00 +0200Paediatric investigation plansEMEA-003376-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003376-pip01-22EMEA-003376-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003376-pip01-22Tue, 18 Jun 2024 15:47:32 +0200Paediatric investigation plansEMEA-003374-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003374-pip01-22EMEA-003374-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003374-pip01-22Tue, 18 Jun 2024 14:50:06 +0200Paediatric investigation plansEMEA-003373-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003373-pip01-22EMEA-003373-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003373-pip01-22Tue, 18 Jun 2024 14:30:17 +0200Paediatric investigation plansEMEA-003372-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003372-pip01-22EMEA-003372-PIP01-22https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-003372-pip01-22Tue, 18 Jun 2024 14:04:51 +0200Paediatric investigation plans