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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100961-PIP01-23
  • depemokimab
  • Treatment of hypereosinophilic syndrome (HES)
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 06/11/2024
MHRA-101447-PIP01-24-M01 (update)
  • DIFELIKEFALIN ACETATE
  • Treatment of chronic kidney disease associated pruritus.
  • Kapruvia
  • Other: Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 06/11/2024
MHRA-100959-PIP01-23-M02 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Jemperli
  • Jemperli
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100623-PIP01-22-M02 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100448-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Vitiligo
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100183-PIP01-21-M03 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100623-PIP01-22-M02 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/10/2024
MHRA-100993-PIP01-23-M02 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101021-PIP01-23-M02 (update)
  • FILGOTINIB MALEATE
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis).
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100111-PIP01-21-M01 (update)
  • Islatravir
  • DORAVIRINE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101493-PIP01-24
  • anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853)
  • Treatment of Parkinson's disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-100482-PIP01-22-M02 (update)
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of Niemann-Pick Disease Type C (NPC)
  • Aqneursa
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-101630-PIP01-24-M01 (update)
  • LISOCABTAGENE MARALEUCEL
  • Treatment of B-lymphoblastic leukaemia/lymphoma
  • Treatment of mature B-cell neoplasm
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-100044-PIP01-21-M02 (update)
  • seltorexant
  • Treatment of major depressive disorder.
  • Not available at present
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100284-PIP01-21-M03 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Namuscla
  • Namuscla
  • Other: Muscle disorders
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-100670-PIP01-22-M01 (update)
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Brexafemme
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
MHRA-101520-PIP01-24-M01 (update)
  • ECULIZUMAB
  • Treatment of neuromyelitis optica spectrum disorders.
  • SOLIRIS
  • SOLIRIS
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 28/10/2024
MHRA-101117-PIP01-23-M02 (update)
  • ORITAVANCIN
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Tenkasi
  • Tenkasi
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Orbactiv
  • Tenkasi
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100451-PIP01-22-M03 (update)
  • fidanacogene elaparvovec
  • Treatment of congenital factor IX deficiency (haemophilia B)
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 28/10/2024
MHRA-100502-PIP01-22-M03 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza disease
  • Supemtek
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 28/10/2024
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