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Displaying 41 - 60 of 122
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100874-PIP01-23
  • PEMBROLIZUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100834-PIP01-23
  • SOTORASIB
  • Treatment of colorectal carcinoma
  • Lumykras
  • Lumykras
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-101079-PIP01-23-M01 (update)
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  •  Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100950-PIP01-23
  • lutetium-177 (177Lu) rhPSMA 10.1
  • Treatment of prostate cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100858-PIP01-23
  • sabatolimab
  • Treatment of myelodysplastic syndromes
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-101034-PIP01-23
  • Belrestotug
  • GSK4428859A
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100969-PIP01-23
  • V940 (mRNA-4157), Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens
  • Treatment of lung cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100980-PIP01-23
  • 1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101059-PIP01-23
  • [(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride)
  • Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) / Palmitoyl-KSS-KKLLMGTLGIVCPICSQKP(HPV-16 E7 82-98) / Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90) /Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45)
  • Treatment of human papilloma virus (HPV) type 16 positive malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101090-PIP01-23
  • tiragolumab
  • Treatment of hepatocellular carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100985-PIP02-23
  • BINIMETINIB
  • Treatment of lung cancer
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Mektovi
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100986-PIP02-23
  • ENCORAFENIB
  • Treatment of lung cancer
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Braftovi
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101085-PIP01-23
  • Humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101100-PIP01-23
  • Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)
  • Treatment of breast malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101122-PIP01-23
  • ENFORTUMAB VEDOTIN
  • Treatment of head and neck epithelial malignant neoplasms
  • Padcev
  • Padcev
  • Padcev
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101118-PIP01-23
  • 5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7
  • Treatment of head and neck squamous cell carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100832-PIP01-23-M01 (update)
  • LANADELUMAB
  • Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • Other: Genetic disease
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100199-PIP01-21
  • efgartigimod alfa
  • Treatment of Pemphigus
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100251-PIP01-21
  • DUPILUMAB
  • Chronic pruritus of unknown origin
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023