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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-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-102020-PIP01-25-M01 (update)
  • tezepelumab
  • Treatment of asthma
  • TEZSPIRE
  • TEZSPIRE
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101923-PIP01-25
  • Pimicotinib hydrochloride hydrate
  • Treatment of tenosynovial giant cell tumours
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100092-PIP01-21-M04 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102064-PIP01-25-M01 (update)
  • MERCAPTAMINE HYDROCHLORIDE
  • Treatment of cystinosis.
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101905-PIP01-25
  • FUROSEMIDE
  • Treatment of fluid retention
  • Cardiovascular Diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100130-PIP01-21-M03 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100216-PIP01-21-M05 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis.
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100681-PIP01-22-M02 (update)
  • LOMITAPIDE MESYLATE
  • Treatment of heterozygous and homozygous familial hypercholesterolaemia
  • Lojuxta
  • Lojuxta
  • Lojuxta
  • Lojuxta
  • Juxtapid
  • Lojuxta
  • Juxtapid
  • Juxtapid
  • Juxtapid
  • Juxtapid
  • Other: Hypercholesterolaemia (HoFH)
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100709-PIP01-22-M02 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. 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-101641-PIP01-24
  • Japanese encephalitis virus, strain SA14-14-2, Live
  • Prevention of Japanese encephalitis
  • IMOJEV
  • IMOJEV
  • IMOJEV
  • Infectious diseases
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101404-PIP01-24-M01 (update)
  • TRASTUZUMAB DERUXTECAN
  • Treatment of all conditions in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Enhertu
  • Enhertu
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101356-PIP01-24-M01 (update)
  • inebilizumab
  • Treatment of myasthenia gravis
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Xinyue
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Uplizna
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100230-PIP01-21-M01 (update)
  • Nerandomilast
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100439-PIP01-22-M01 (update)
  • Asundexian
  • Prevention of arterial thromboembolism
  • Not available at present
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100253-PIP01-21-M02 (update)
  • Zuranolone
  • Treatment of postpartum depression
  • Zurzuvae
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100145-PIP01-21-M02 (update)
  • BRIGATINIB
  • Treatment of non-small cell lung cancer (NSCLC)
  • Treatment of anaplastic large cell lymphoma (ALCL)
  • Treatment of Inflammatory myofibroblastic tumours
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100578-PIP01-22-M01 (update)
  • SEMAGLUTIDE
  • Cagrilintide
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101908-PIP01-25-M01 (update)
  • MOSUNETUZUMAB
  • Treatment of mature B-cell neoplasms
  • Lunsumio
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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