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Displaying 61 - 80 of 173
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100044-PIP01-21
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100253-PIP01-21
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100398-PIP01-21
  • ralmitaront
  • Treatment of schizophrenia
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100593-PIP01-22
  • aticaprant
  • Treatment of Major Depressive Disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/01/2024
MHRA-100050-PIP01-21
  • efgartigimod alfa
  • Treatment of Immune thrombocytopenia
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100140-PIP01-21
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100179-PIP01-21
  • vemircopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100179-PIP01-21
  • vemircopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100027-PIP01-21
  • benzylamine derivative of benzofuran
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100091-PIP01-21
  • Rozanolixizumab
  • Treatment of Immune thrombocytopenia
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100266-PIP01-21
  • Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100267-PIP01-21
  • Autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene
  • Treatment of beta-thalassemia intermedia and major
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100372-PIP01-21
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100559-PIP01-22
  • mitapivat
  • Treatment of thalassaemia
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100635-PIP01-22
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • INAQOVI
  • Haematology-Hemostaseology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100885-PIP01-23
  • Iptacopan
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
  • Not available at present; Product code: LNP023
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 19/12/2023
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) No 24/08/2023
MHRA-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes 03/11/2021
MHRA-100038-PIP01-21
  • Recombinant protein derived from the SARS CoV2 prefusion Spike delta TM protein adjuvanted with AS03
  • Prevention of Covid-19
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021