Displaying 81 - 100 of 1088
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100824-PIP01-22
  • perflubutane
  • Diagnostic evaluation of focal hepatic lesions
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Diagnostic
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100823-PIP01-22-M03 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100816-PIP01-22-M01 (update)
  • crovalimab
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Treatment of atypical haemolytic uremic syndrome
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100796-PIP01-22
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100787-PIP01-22
  • Repotrectinib
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
  • Not available at present
  • Oncology
  • Other: Not Applicable
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100714-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated gonorrhoea
  • Blujepa
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100700-PIP01-22-M01 (update)
  • BIRCH POLLEN
  • Treatment of allergic rhinitis/ rhino-conjunctivitis
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • ITULAZAX
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100690-PIP01-22-M02 (update)
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms.
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100687-PIP01-22-M01 (update)
  • OBINUTUZUMAB
  • Treatment of systemic lupus erythematosus
  • Gazyvaro
  • Gazyvaro
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100674-PIP01-22-M02 (update)
  • DARATUMUMAB
  • Treatment of lymphoid malignancies (except mature B-cell neoplasms)
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • DARZALEX FASPRO
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Darzalex
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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 Partial Compliance Check Granted
MHRA-100657-PIP01-22-M01 (update)
  • BULEVIRTIDE
  • Treatment of chronic hepatitis D infection
  • Hepcludex
  • Hepcludex
  • Myrcludex B
  • Gastroenterology-Hepatology
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100635-PIP01-22-M03 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100628-PIP01-22
  • Sibeprenlimab
  • Treatment of primary immunoglobulin A nephropathy
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100625-PIP01-22-M01 (update)
  • RISANKIZUMAB
  • Treatment of psoriasis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100717-PIP01-22-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100641-PIP01-22-M02 (update)
  • DURVALUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • IMFINZI
  • IMFINZI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100115-PIP01-21-M01 (update)
  • Dersimelagon
  • Treatment of erythropoetic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
  • Other: Genetic medicine
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101855-PIP01-25
  • unasnemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No