Human medicinehttps://www.ema.europa.eu/en/homepageHuman medicineen-gbCopyright: (C) European Medicines AgencyWed, 17 Jul 2024 03:25:17 +0200Thu, 13 Jun 2024 16:26:00 +0200Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Date of authorisation: 23/07/2012, Revision: 41, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kalydecoHuman medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Date of authorisation: 23/07/2012, Revision: 41, Status: Authorisedhttps://www.ema.europa.eu/en/medicines/human/EPAR/kalydecoThu, 13 Jun 2024 16:26:00 +0200Human medicineOpinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0002/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000335-pip01-08-m15Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0002/2023https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000335-pip01-08-m15Wed, 14 Feb 2024 17:17:00 +0100Human medicineKalydeco-H-C-2494-X-0034-G : EPAR - Assessment Report - Extensionhttps://www.ema.europa.eu/system/files/documents/variation-report/wc500198918_en.pdfKalydeco-H-C-2494-X-0034-G : EPAR - Assessment Report - Extensionhttps://www.ema.europa.eu/system/files/documents/variation-report/wc500198918_en.pdfWed, 16 Dec 2020 01:00:00 +0100Human medicine