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Displaying 61 - 80 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101581-PIP01-24
  • rinatabart sesutecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of peritoneal cancer.
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-101573-PIP01-24
  • Trofinetide
  • Treatment of Rett syndrome
  • Not yet available in the United Kingdom (Daybu proposed in the EEA and currently being assessed)
  • Daybue
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-101570-PIP01-24
  • firmonertinib
  • Treatment of non-small cell lung cancer (NSCLC)
  • firmonertinib
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-101171-PIP01-23-M01 (update)
  • fosigotifator sodium tromethamine
  • Treatment of vanishing white matter disease
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101564-PIP01-24
  • (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)
  • Treatment of all solid and haematological malignancies
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-100046-PIP01-21-M05 (update)
  • cenobamate
  • Treatment of epilepsy
  • Ontozry
  • Ontozry
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101540-PIP01-24
  • derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride
  • Treatment of psoriasis
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-100630-PIP01-22-M02 (update)
  • PATIROMER SORBITEX CALCIUM
  • Treatment of hyperkalaemia
  • Veltassa
  • Veltassa
  • Other: Nephrology/Metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101538-PIP01-24
  • NIVOLUMAB
  • relatlimab
  • Treatment of melanoma
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-101543-PIP01-24-M01 (update)
  • SELUMETINIB HYDROGEN SULFATE
  • Treatment of neurofibromatosis type 1
  • Treatment of thyroid cancer
  • Treatment of melanoma
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Koselugo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-100317-PIP01-21-M01 (update)
  • Ralinepag
  • Treatment of pulmonary arterial hypertension
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101525-PIP01-24
  • Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)
  • Treatment of PSMA-expressing prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 06/01/2025
MHRA-101509-PIP01-24
  • Ferric Citrate Coordination Complex
  • Treatment of anaemias due to chronic kidney disorders
  • Xoanacyl
  • Auryxia
  • Riona
  • Nephoxil
  • Nephoxil
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-100352-PIP01-21-M03 (update)
  • AVAPRITINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-100966-PIP01-23-M01 (update)
  • Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants)
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer – XBB.1.16-XBB.1.16 variant
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Bimervax
  • Bimervax
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101451-PIP01-24-M01 (update)
  • Osivelotor
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101451-PIP01-24
  • Osivelotor
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-100019-PIP01-21-M01 (update)
  • BELUMOSUDIL MESYLATE
  • Treatment of chronic Graft versus Host Disease (cGVHD)
  • Rezurock
  • Rezurock
  • Rholistiq
  • Rholistiq
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Belumosudil
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025
MHRA-101177-PIP01-23
  • Recombinant humanized IgG1, kappa light chain, long-acting monoclonal antibody
  • (navenibart; STAR-0215)
  • Treatment of hereditary angioedema
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/01/2025
MHRA-101167-PIP01-23-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cometriq
  • Cometriq
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/01/2025