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Displaying 1 - 20 of 208
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100431-PIP01-22
  • derivative of pyrrolopyrimidine
  • Prevention of cardiovascular events in patients with heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100185-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of cold agglutinin disease
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100125-PIP01-21
  • PEMBROLIZUMAB
  • vibostolimab
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100136-PIP01-21
  • PEMBROLIZUMAB
  • quavonlimab
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100490-PIP01-22-M01 (update)
  • nirsevimab (MEDI8897)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Beyfortus
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100164-PIP01-21-M01 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100149-PIP01-21-M01 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • TBD - Approval not yet granted
  • TBD - Approval not yet granted
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100352-PIP01-21-M01 (update)
  • AVAPRITINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100377-PIP01-21-M01 (update)
  • ACALABRUTINIB
  • Treatment of mature B cell neoplasms
  • calquence
  • calquence
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100370-PIP01-21-M01 (update)
  • EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS
  • Treatment of limbal stem cell deficiency due to ocular burns
  • Holoclar
  • Holoclar
  • Holoclar
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100328-PIP01-21-M01 (update)
  • METRELEPTIN
  • Treatment of lipodystrophy
  • Myalepta Powder for Solution for Injection
  • Myalepta
  • Myalepta
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100341-PIP01-21-M01 (update)
  • ISAVUCONAZONIUM SULFATE
  • Treatment of invasive aspergillosis
  • Treatment of mucormycosis
  • Cresemba
  • Cresemba
  • Cresemba
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100249-PIP01-21-M01 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM BROMIDE
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100233-PIP01-21-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Aptimetyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100182-PIP01-21-M01 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100260-PIP01-21-M01 (update)
  • CEMIPLIMAB
  • Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Libtayo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100238-PIP01-21-M01 (update)
  • AVELUMAB
  • Treatment of malignant neoplasms of the CNS, lymphoid tissue and other malignant neoplasms.
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100258-PIP01-21-M01 (update)
  • Fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus
  • Not available yet
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100240-PIP01-21-M01 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukaemia (CML)
  • Bosulif
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100158-PIP01-21-M01 (update)
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Keytruda
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022