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 161 - 180 of 1015
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101442-PIP01-24
  • Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)
  • Treatment of urothelial carcinoma
  • Treatment of cutaneous squamous cell carcinoma
  • Treatment of renal cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101384-PIP01-24
  • Telisotuzumab adizutecan
  • Treatment of colorectal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101500-PIP01-24
  • Zanidatamab
  • Treatment of gastroesophageal adenocarcinoma (GEA).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101499-PIP01-24
  • Zanidatamab
  • Treatment of HER2-positive breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101426-PIP01-24
  • Deutetrabenazine
  • Treatment of tardive dyskinesia
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101319-PIP01-23-M01 (update)
  • denecimig
  • Treatment of haemophilia A
  • Not available at present
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101129-PIP01-23
  • Domvanalimab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101128-PIP01-23
  • Domvanalimab
  • Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101441-PIP01-24
  • modified recombinant version of the human myeloid-derived growth factor
  • Treatment of ischaemic coronary artery disorders
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101199-PIP01-23
  • Inhibitor of receptor-interacting protein kinase 1
  • Treatment of ulcerative colitis
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101174-PIP01-23
  • LENACAPAVIR SODIUM
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • Sunlenca
  • Sunlenca
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100961-PIP01-23
  • depemokimab
  • Treatment of hypereosinophilic syndrome (HES)
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101447-PIP01-24-M01 (update)
  • DIFELIKEFALIN ACETATE
  • Treatment of chronic kidney disease associated pruritus.
  • Kapruvia
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100959-PIP01-23-M02 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Jemperli
  • Jemperli
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100623-PIP01-22-M02 (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. No
MHRA-100448-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Vitiligo
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100183-PIP01-21-M03 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100623-PIP01-22-M02 (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. No
MHRA-100993-PIP01-23-M02 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101021-PIP01-23-M02 (update)
  • FILGOTINIB MALEATE
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis).
  • Jyseleca
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No