Displaying 81 - 100 of 970
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101175-PIP01-23
  • baxdrostat
  • Treatment of hypertension
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 03/10/2024
MHRA-101151-PIP01-23-M01 (update)
  • OBETICHOLIC ACID
  • Treatment of primary biliary cirrhosis
  • Treatment of biliary atresia
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/10/2024
MHRA-100146-PIP01-21
  • tezepelumab
  • Treatment of eosinophilic esophagitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-101111-PIP01-23
  • Cendakimab (BMS-986355)
  • Treatment of Eosinophilic Esophagitis (EoE)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/10/2024
MHRA-101349-PIP01-24
  • SECUKINUMAB
  • Treatment of rotator cuff tendinopathy
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-101246-PIP01-23-M01 (update)
  • MEROPENEM
  • VABORBACTAM
  • Treatment of Gram-negative bacterial infections
  • Vaborem
  • Vaborem
  • Vabomere
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101000-PIP01-23-M02 (update)
  • Rilzabrutinib
  • Treatment of immune thrombocytopenia.
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100678-PIP01-22-M01 (update)
  • vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101282-PIP01-23
  • eftilagimod alfa
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024
MHRA-101094-PIP01-23-M01 (update)
  • Givinostat
  • Treatment of Duchenne muscular dystrophy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100743-PIP01-22-M02 (update)
  • efgartigimod alfa
  • Treatment of myasthenia gravis
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart Hytrulo
  • Vyvgart
  • Vyvdura
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100312-PIP01-21-M02 (update)
  • RITLECITINIB TOSYLATE
  • Treatment of alopecia areata
  • Litfulo
  • Litfulo
  • Litfulo
  • Litfulo
  • Litfulo
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100216-PIP01-21-M03 (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 15/08/2024
MHRA-100580-PIP01-22-M02 (update)
  • CEMIPLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
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 15/08/2024
MHRA-101375-PIP01-24-M01 (update)
  • FREMANEZUMAB
  • Prophylaxis of migraine headaches
  • Ajovy
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-100690-PIP01-22-M02 (update)
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms.
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101389-PIP01-24
  • omaveloxolone
  • Treatment of Friedreich's ataxia
  • Skyclarys
  • Skyclarys
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 15/08/2024
MHRA-100635-PIP01-22-M01 (update)
  • CEDAZURIDINE
  • DECITABINE
  • Treatment of acute myeloid leukaemia
  • INAQOVI
  • INAQOVI
  • INQOVI
  • INQOVI
  • Inqovi 35/100
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/08/2024
MHRA-101409-PIP01-24-M01 (update)
  • IVOSIDENIB
  • Treatment of Acute Myeloid Leukaemia.
  • Tibsovo
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 15/08/2024