Displaying 1 - 20 of 333
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100376-PIP01-21-M01 (update)
  • VEDOLIZUMAB
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 22/12/2022
MHRA-100556-PIP01-22
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100458-PIP01-22
  • Modakafusp alfa
  • Treatment of multiple myeloma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100135-PIP02-22
  • anti-CD40L humanised monoclonal antibody (SAR441344)
  • Treatment of progressive Multiple Sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
MHRA-100254-PIP01-21-M01 (update)
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100053-PIP01-21 -M02 (update)
  • IMDEVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100052-PIP01-21-M02 (update)
  • CASIRIVIMAB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100507-PIP01-22-M02 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100600-PIP01-22-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease
  • Imvanex
  • Imvamune
  • Jynneos
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100623-PIP01-22-M01 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100608-PIP01-22-M01 (update)
  • mitapivat
  • Treatment of pyruvate kinase deficiency
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100075-PIP01-21-M01 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100601-PIP01-22-M01 (update)
  • elasomeran
  • imelasomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax bivalent Original / Omicron
  • Spikevax
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100566-PIP01-22-M01 (update)
  • MIRABEGRON
  • Treatment of neurogenic detrusor overactivity
  • BETMIGA
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100557-PIP01-22-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • HEPLISAV-B
  • HEPLISAV-B
  • HEPLISAV B
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100564-PIP01-22-M01 (update)
  • TEDIZOLID PHOSPHATE
  • Treatment of acute bacterial skin and skin structure infections
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Sivextro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100501-PIP01-22-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100028-PIP01-21-M01 (update)
  • TIXAGEVIMAB
  • CILGAVIMAB
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Treatment of COVID-19
  • Evusheld
  • Evusheld
  • Evusheld
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100522-PIP01-22-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 07/12/2022
MHRA-100511-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of Crohn's disease
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022