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Displaying 1 - 20 of 123
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100022-PIP01-21
  • bimekizumab
  • Hidradenitis suppurativa
  • Immunology -Rheumatology-Transplantation
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100200-PIP01-21-M03 (update)
  • REGORAFENIB
  • Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Stivarga
  • Stivarga
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100286-PIP01-21-M02 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • STELARA
  • Stelara
  • STELARA
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100966-PIP01-23-M02 (update)
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - Omicron LP.8.1-LP.8.1 variant
  • selvacovatein
  • damlecovatein
  • Prevention of coronavirus disease 2019 (COVID-19)
  • BIMERVAX, BIMERVAX XBB.1.16, BIMERVAX LP.8.1
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • Bimervax
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100623-PIP01-22-M03 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoetic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100959-PIP01-23-M03 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102230-PIP01-25-M01 (update)
  • Rebisufligene etisparvovec
  • Treatment of mucopolysaccharidosis IIIA
  • Not available at present
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100266-PIP01-21-M01 (update)
  • EXAGAMGLOGENE AUTOTEMCEL
  • Treatment of sickle cell disease
  • Casgevy
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100267-PIP01-21-M01 (update)
  • EXAGAMGLOGENE AUTOTEMCEL
  • Treatment of beta-thalassemia intermedia and major
  • Casgevy
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102316-PIP01-26-M01 (update)
  • ERAVACYCLINE
  • Treatment of complicated intra-abdominal infection
  • Xerava
  • Xerava
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100406-PIP01-21-M03 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A Treatment of congenital haemophilia B
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100069-PIP01-21-M01 (update)
  • RIBOCICLIB SUCCINATE
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102050-PIP01-25
  • Aficamten
  • Treatment of hypertrophic cardiomyopathy
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-102202-PIP01-25-M01 (update)
  • ONASEMNOGENE ABEPARVOVEC
  • Treatment of spinal muscular atrophy.
  • Zolgensma
  • Zolgensma
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102165-PIP01-25
  • adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene
  • adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene
  • Treatment of otoferlin gene-mediated hearing loss
  • Oto-Rhino-Laryngology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-102031-PIP01-25
  • resmetirom
  • Treatment of metabolic dysfunction-associated steatohepatitis
  • Rezdiffra
  • Rezdiffra
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101824-PIP01-25
  • AAV8-RK-AIPL1
  • Treatment of Leber congenital amaurosis
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100297-PIP01-21-M05 (update)
  • Rocatinlimab
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102032-PIP01-25-M01 (update)
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
  • Trumenba
  • Trumenba
  • Trumenba
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100471-PIP01-22-M03 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted