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Displaying 161 - 180 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-100850-PIP01-23
  • deucravacitinib
  • Treatment of Sjogren's Syndrome
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100874-PIP01-23
  • PEMBROLIZUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Oncology
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-100873-PIP01-23
  • Meningococcal Group A, C, W-135 and Y conjugate vaccine
  • Meningococcal meningitis
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  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(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-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-100957-PIP01-23
  • deucravacitinib
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100722-PIP01-22
  • Ritlecitinib
  • Treatment of vitiligo
  • Dermatology
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-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-100894-PIP01-23
  • depemokimab
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100446-PIP01-22
  • Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one
  • 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 19/12/2023
MHRA-100933-PIP01-23
  • camlipixant
  • Treatment of unexplained or chronic refractory cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100678-PIP01-22
  • Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
  • Treatment of uveitic macular oedema
  • Not available at present
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100840-PIP01-23
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100096-PIP01-21
  • Live, attenuated, dengue virus, serotype 1 (DENV1)
  • Live, attenuated, chimeric dengue virus, serotype 2 (DENV2)
  • Live, attenuated, dengue virus, serotype 3 (DENV3)
  • Live, attenuated, dengue virus, serotype 4 (DENV4)
  • Prevention of dengue disease
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100919-PIP01-23
  • Bepirovirsen
  • Treatment of chronic hepatitis B infection
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100299-PIP01-21
  • Humanized monoclonal IgG1-based antibody
  • Treatment of spinal muscular atrophy
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100796-PIP01-22
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023