Displaying 661 - 680 of 773
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100754-PIP01-22
  • Live-attenuated La Reunion strain of chikungunya virus
  • Prevention of chikungunya virus disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100809-PIP01-22
  • Efruxifermin
  • Treatment of non-alcoholic steatohepatitis (NASH)
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100882-PIP01-23
  • Glucagon analogue linked to a human immunoglobulin Fc fragment
  • Treatment of congenital hyperinsulinism
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-101019-PIP01-23
  • Treprostinil Palmitil
  • Treatment of pulmonary hypertension due to lung disease and/or hypoxia.
  • Not available at present
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100873-PIP01-23
  • Meningococcal Group A, C, W-135 and Y conjugate vaccine
  • Meningococcal meningitis
  • Menveo
  • Menveo
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  • Menveo
  • Menveo
  • Menveo
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100848-PIP01-23
  • messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene
  • Treatment for transthyretin amyloidosis (ATTR)
  • Not available at present
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100927-PIP01-23
  • Namilumab
  • Treatment of sarcoidosis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
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-100974-PIP01-23
  • BOTULINUM TOXIN TYPE A
  • Treatment of skin wrinkling
  • Not yet defined
  • Other: Aesthetics
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100995-PIP01-23
  • LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100878-PIP01-23
  • vibegron
  • Treatment of myoneurogenic bladder disorders
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100465-PIP01-22-M02 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-100868-PIP01-23-M01 (update)
  • AFAMELANOTIDE
  • Treatment of erythropoietic protoporphyria (EPP)
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101023-PIP01-23-M01 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • ZTALMY
  • ZTALMY
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101023-PIP01-23-M02 (update)
  • ganaxolone
  • Treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100758-PIP01-22-M01 (update)
  • BEZLOTOXUMAB
  • Prevention of recurrence of Clostridioides difficile infection
  • ZINPLAVA
  • ZINPLAVA
  • ZINPLAVA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100931-PIP01-23-M01 (update)
  • mirikizumab
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. 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-100907-PIP01-23-M01 (update)
  • CEFTOLOZANE
  • TAZOBACTAM
  • Treatment of pneumonia
  • ZERBAXA
  • ZERBAXA
  • ZERBAXA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100818-PIP01-22-M01 (update)
  • BEMPEDOIC ACID
  • Treatment of elevated cholesterol
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nexletol® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023