Displaying 481 - 500 of 1188
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100216-PIP01-21-M04 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis
  • Adtralza
  • 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-101619-PIP01-24
  • spesolimab
  • Treatment of hidradenitis suppurativa
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Spevigo
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101542-PIP01-24
  • lutikizumab
  • Treatment of hidradenitis suppurativa
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101660-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of prurigo nodularis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100297-PIP01-21-M04 (update)
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of atopic dermatitis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101661-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of atopic dermatitis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100044-PIP01-21
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100175-PIP01-21-M01 (update)
  • AGOMELATINE
  • Treatment of major depressive episodes
  • Valdoxan
  • Valdoxan
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100253-PIP01-21
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100398-PIP01-21
  • ralmitaront
  • Treatment of schizophrenia
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100395-PIP01-21
  • TALAZOPARIB TOSYLATE
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Psychiatry
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100507-PIP01-22-M01 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100507-PIP01-22-M02 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100515-PIP01-22-M01 (update)
  • VORTIOXETINE
  • Treatment of Major Depressive Disorder
  • Brintellix
  • Brintellix
  • Brintellix
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100253-PIP01-21-M01 (update)
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100593-PIP01-22
  • aticaprant
  • Treatment of Major Depressive Disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101342-PIP01-24-M01 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of major depressive disorder (MDD)
  • Spravato
  • Spravato
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100044-PIP01-21-M01 (update)
  • seltorexant
  • Treatment of major depressive disorder (MDD)
  • Not available at present
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101388-PIP01-24-M01 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia.
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No