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Displaying 521 - 540 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
PIP Number MHRA-100917-PIP01-23 Active Substance
  • efgartigimod alfa
Conditions / Indications
  • Treatment of Bullous Pemphigoid
Invented Name
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
Therapeutic area
  • Dermatology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100927-PIP01-23 Active Substance
  • Namilumab
Conditions / Indications
  • Treatment of sarcoidosis
Invented Name
  • Not available at present
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100850-PIP01-23 Active Substance
  • deucravacitinib
Conditions / Indications
  • Treatment of Sjogren's Syndrome
Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100874-PIP01-23 Active Substance
  • PEMBROLIZUMAB
Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
Invented Name
  • Keytruda
Therapeutic area
  • Oncology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100848-PIP01-23 Active Substance
  • messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene
Conditions / Indications
  • Treatment for transthyretin amyloidosis (ATTR)
Invented Name
  • Not available at present
Therapeutic area
  • Neurology
  • Cardiovascular Diseases
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100873-PIP01-23 Active Substance
  • Meningococcal Group A, C, W-135 and Y conjugate vaccine
Conditions / Indications
  • Meningococcal meningitis
Invented Name
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
Therapeutic area
  • Vaccines
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-101019-PIP01-23 Active Substance
  • Treprostinil Palmitil
Conditions / Indications
  • Treatment of pulmonary hypertension due to lung disease and/or hypoxia.
Invented Name
  • Not available at present
Therapeutic area
  • Pneumology - Allergology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100882-PIP01-23 Active Substance
  • Glucagon analogue linked to a human immunoglobulin Fc fragment
Conditions / Indications
  • Treatment of congenital hyperinsulinism
Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100957-PIP01-23 Active Substance
  • deucravacitinib
Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
Invented Name
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
Therapeutic area
  • Immunology -Rheumatology-Transplantation
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100722-PIP01-22 Active Substance
  • Ritlecitinib
Conditions / Indications
  • Treatment of vitiligo
Invented Name Therapeutic area
  • Dermatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100809-PIP01-22 Active Substance
  • Efruxifermin
Conditions / Indications
  • Treatment of non-alcoholic steatohepatitis (NASH)
Invented Name
  • Not available at present
Therapeutic area
  • Gastroenterology-Hepatology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100754-PIP01-22 Active Substance
  • Live-attenuated La Reunion strain of chikungunya virus
Conditions / Indications
  • Prevention of chikungunya virus disease
Invented Name Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100894-PIP01-23 Active Substance
  • depemokimab
Conditions / Indications
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100446-PIP01-22 Active Substance
  • Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one
Conditions / Indications
  • Treatment of Chronic Kidney Disease
Invented Name Therapeutic area
  • Uro-Nephrology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100933-PIP01-23 Active Substance
  • camlipixant
Conditions / Indications
  • Treatment of unexplained or chronic refractory cough
Invented Name Therapeutic area
  • Pneumology - Allergology
Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100678-PIP01-22 Active Substance
  • Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)
Conditions / Indications
  • Treatment of uveitic macular oedema
Invented Name
  • Not available at present
Therapeutic area
  • Ophthamology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100840-PIP01-23 Active Substance
  • Odronextamab
Conditions / Indications
  • Treatment of mature B cell malignancies
Invented Name Therapeutic area
  • Oncology
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending
PIP Number MHRA-100885-PIP01-23 Active Substance
  • Iptacopan
Conditions / Indications
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
Invented Name
  • Not available at present; Product code: LNP023
Therapeutic area
  • Haematology-Hemostaseology
  • Other: Complement-driven renal disease
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check Yes Compliance outcome Partial Compliance Check Granted Date Published Sort ascending
PIP Number MHRA-100787-PIP01-22 Active Substance
  • Repotrectinib
Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
Invented Name
  • Not available at present
Therapeutic area
  • Oncology
  • Other: Not Applicable
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check Yes Compliance outcome Date Published Sort ascending
PIP Number MHRA-100096-PIP01-21 Active Substance
  • 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)
Conditions / Indications
  • Prevention of dengue disease
Invented Name
  • Not available at present
Therapeutic area
  • Vaccines
Decision Type P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Compliance Check No Compliance outcome Date Published Sort ascending