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 201 - 220 of 263
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-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
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
MHRA-101826-PIP01-25
  • Orforglipron
  • Treatment of obesity
  • Not available at present
  • 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-101319-PIP01-23-M02 (update)
  • denecimig
  • Treatment of haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102006-PIP01-25
  • beremagene geperpavec
  • Treatment of dystrophic epidermolysis bullosa
  • Vyjuvek
  • Vyjuvek
  • Vyjuvek
  • Vyjuvek
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101112-PIP01-23-M02 (update)
  • Icotrokinra
  • Treatment of psoriasis.
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101923-PIP01-25
  • Pimicotinib hydrochloride hydrate
  • Treatment of tenosynovial giant cell tumours
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102064-PIP01-25-M01 (update)
  • MERCAPTAMINE HYDROCHLORIDE
  • Treatment of cystinosis.
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101905-PIP01-25
  • FUROSEMIDE
  • Treatment of fluid retention
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101995-PIP01-25-M01 (update)
  • ISOFLURANE
  • Sedation of mechanically ventilated patients
  • Sedaconda and associated names
  • Other: Sedation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100214-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uraemic syndrome (aHUS)
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted