Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 181 - 200 of 257
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100139-PIP01-21
  • Teplizumab
  • Prevention or delay of (clinical) type 1 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100118-PIP01-21-M04 (update)
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100117-PIP01-21-M03 (update)
  • ISATUXIMAB
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Sarclisa
  • Sarclisa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100089-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100065-PIP01-21-M01 (update)
  • TICAGRELOR
  • Prevention of thromboembolic events
  • Brilique
  • Brilique
  • Brilique
  • Brilique
  • Cardiovascular Diseases
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100064-PIP01-21-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100036-PIP01-21-M03 (update)
  • FERRIC MALTOL
  • Iron deficiency anaemia (IDA)
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • FERACCRU
  • Accrufer
  • FERACCRU
  • FERACCRU
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100031-PIP01-21-M02 (update)
  • PALBOCICLIB
  • Treatment of Ewing sarcoma (EWS)
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • Ibrance
  • blisters in an outer carton/21 and 63 tablets
  • Ibrance
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100025-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100024-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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-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-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-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