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Displaying 1 - 20 of 887
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101616-PIP01-24
  • Multivalent pneumococcal polysaccharide vaccine
  • Prevention of pneumococcal disease caused by S. pneumoniae
  • N/A
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102466-PIP01-26
  • Aleniglipron
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102594-PIP01-26
  • ELECOGLIPRON
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101711-PIP01-24-M02 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102591-PIP01-26
  • Bemdaneprocel
  • Treatment of Parkinson’s disease.
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100432-PIP01-22-M01 (update)
  • Zilurgisertib
  • Treatment of fibrodysplasia ossificans progressiva
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100129-PIP01-21-M04 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Pombiliti
  • Pomiliti
  • Pombilti
  • Pombiliti
  • Pombiliti
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100102-PIP01-21-M03 (update)
  • INDACATEROL ACETATE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Atectura Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101964-PIP01-25-M01 (update)
  • Orforglipron
  • Treatment of Type 2 Diabetes Mellitus
  • Foundayo
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102598-PIP01-26
  • Orelabrutinib
  • Treatment of marginal zone lymphoma
  • Hibruka
  • Hibruka
  • Hibruka
  • Hibruka
  • Yinuokai
  • Yinuokai
  • Yinuokai
  • Yinuokai
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102587-PIP01-26
  • orelabrutinib
  • Treatment of mantle cell lymphoma
  • Hibruka
  • Hibruka
  • Yinuokai
  • Hibruka
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101005-PIP02-26
  • Bocunebart
  • Preventive treatment of migraine
  • Not available at present
  • Neurology
  • Pain
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102524-PIP01-26
  • 7-fluoro-1-isopropyl-3-methyl-8-(6-(3-(piperidin-1- yl)propoxy)pyridin-3-yl)-1,3-dihydro-2H-imidazo[4,5-c]quinolin-2-one
  • AZD1390
  • Treatment of malignant neoplasms of the central nervous system
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102525-PIP01-26
  • Balcinrenone
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102057-PIP01-25
  • Fetrastobart vedotin
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102530-PIP01-26
  • inebilizumab
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Xinyue
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102443-PIP01-26
  • Telisotuzumab adizutecan
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100678-PIP01-22-M03 (update)
  • vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101352-PIP01-24-M02 (update)
  • Lifileucal
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AMTAGVI
  • AMTAGVI
  • AMTAGVI
  • AMTAGVI
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102356-PIP01-26
  • TACROLIMUS MONOHYDRATE
  • Treatment of vernal keratoconjunctivitis
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No