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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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-101897-PIP01-25
  • doxecitine
  • doxribtimine
  • Treatment of thymidine kinase 2 deficiency
  • KYGEVVI
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
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-101794-PIP01-25
  • evenamide
  • Treatment of schizophrenia
  • Psychiatry
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101785-PIP01-25
  • (R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT- 517)
  • Treatment of hyperphenylalaninemia
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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
MHRA-101740-PIP01-24
  • messenger RNA encoding Cas9
  • single guide RNA targeting the human KLKB1 gene
  • Treatment of hereditary angioedema (HAE)
  • Other: Angioedemas, Hereditary
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101727-PIP01-24
  • RAVULIZUMAB
  • Treatment of primary immunoglobulin A nephropathy
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101701-PIP01-24
  • ribitol
  • Treatment of Limb-girdle muscular dystrophy
  • Other: Musculoskeletal
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101606-PIP01-24
  • telisotuzumab adizutecan (ABBV-400)
  • Treatment of gastric and gastroesophageal junction adenocarcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101357-PIP01-24
  • inebilizumab
  • Treatment of immunoglobulin G4-related disease (IgG4-RD)
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101342-PIP01-24-M02 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of Major Depressive Disorder
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101189-PIP01-23
  • N-((1R,2R)-2-methoxycyclobutyl)-7-(methylamino)-5-((2-oxo-2H-[1,2'-bipyridin]-3-yl)amino)pyrazolo[1,5-a]pyrimidine-3-carboxamide
  • Treatment of psoriasis
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101177-PIP01-23-M01 (update)
  • navenibart
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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