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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101985-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101808-PIP01-25-M01 (update)
  • DARVADSTROCEL
  • Treatment of perianal fistula
  • Alofisel
  • Gastroenterology-Hepatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101983-PIP01-25
  • obicetrapib
  • Treatment of mixed dyslipidaemia
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101857-PIP01-25
  • Humanised afucosylated IgG1 monoclonal antibody against CCR8
  • Treatment of all conditions included in the category of malignant neoplasms except melanoma, nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101916-PIP01-25
  • PF-07248144
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101909-PIP01-25
  • 5,8-dichloro-2-[(4-methoxy-6-methyl-2-oxo-1,2-dihydropyridin-3-yl)methyl]-7-[(R)-methoxy(oxetan-3-yl)methyl]-3,4-dihydroisoquinolin-1(2H)-one
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101159-PIP02-25
  • Sacituzumab Tirumotecan
  • Treatment of urothelial carcinoma
  • sac-TMT (佳泰莱®)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101984-PIP01-25
  • obicetrapib
  • EZETIMIBE
  • Treatment of elevated cholesterol
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102010-PIP01-25
  • PEGCETACOPLAN
  • Treatment of geographic atrophy secondary to age related macular degeneration.
  • Syfovre
  • Syfovre
  • Syfovre
  • Syfovre
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101786-PIP02-25
  • (R)-N-(3-(2-Chloro-5-fluorophenyl)-6-(5-cyano-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-1-oxoisoindolin-4-yl)-3-fluoro-5-(trifluoromethyl)benzamide
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101439-PIP01-24-M02 (update)
  • Tolebrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101915-PIP01-25
  • Patritumab deruxtecan
  • Treatment of breast malignant neoplasms
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101881-PIP01-25
  • opevesostat
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101844-PIP01-25
  • SEMAGLUTIDE
  • Prevention of peripheral arterial disease
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101825-PIP01-25
  • AZD6793
  • Treatment of chronic obstructive pulmonary disease (COPD)
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101816-PIP01-25
  • Nipocalimab
  • Prevention of foetal and neonatal alloimmune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101800-PIP01-25
  • OMEPRAZOLE MAGNESIUM
  • AMOXICILLIN TRIHYDRATE
  • RIFABUTIN
  • Treatment of Helicobacter spp. infection
  • Talicia
  • Talicia
  • Talicia
  • Gastroenterology-Hepatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101759-PIP01-24
  • Darovasertib
  • Treatment of ocular melanoma
  • N/A
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101753-PIP01-24
  • Rilvegostomig
  • Treatment of gastric and gastro-oesophageal junction adenocarcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101744-PIP01-24
  • (12M)(1S,2S)-N-((63S,4S,Z)-11-ethyl-12-(2-((S)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11H-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide
  • Treatment of non-small cell lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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