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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
PIP Number MHRA-101426-PIP01-24 Active Substance
  • Deutetrabenazine
 Conditions / Indications
  • Treatment of tardive dyskinesia
 Invented Name
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
 Therapeutic area
  • Neurology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 28/11/2024
PIP Number MHRA-101319-PIP01-23-M01 (update) Active Substance
  • denecimig
Conditions / Indications
  • Treatment of haemophilia A
 Invented Name
  • Not available at present
 Therapeutic area
  • Haematology-Hemostaseology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 28/11/2024
PIP Number MHRA-101129-PIP01-23 Active Substance
  • Domvanalimab
 Conditions / Indications
  • Treatment of lung cancer
 Invented Name 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 28/11/2024
PIP Number MHRA-101128-PIP01-23 Active Substance
  • Domvanalimab
 Conditions / Indications
  • Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.
 Invented Name 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 28/11/2024
PIP Number MHRA-101441-PIP01-24 Active Substance
  • modified recombinant version of the human myeloid-derived growth factor
 Conditions / Indications
  • Treatment of ischaemic coronary artery disorders
 Invented Name
  • Not available at present
 Therapeutic area
  • 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 28/11/2024
PIP Number MHRA-101199-PIP01-23 Active Substance
  • Inhibitor of receptor-interacting protein kinase 1
 Conditions / Indications
  • Treatment of ulcerative colitis
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 28/11/2024
PIP Number MHRA-101174-PIP01-23 Active Substance
  • LENACAPAVIR SODIUM
 Conditions / Indications
  • Prevention of human immunodeficiency virus (HIV-1) infection
 Invented Name
  • Sunlenca
  • Sunlenca
 Therapeutic area
  • Infectious diseases
 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 28/11/2024
PIP Number MHRA-100961-PIP01-23 Active Substance
  • depemokimab
 Conditions / Indications
  • Treatment of hypereosinophilic syndrome (HES)
 Invented Name Therapeutic area
  • Haematology-Hemostaseology
 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 06/11/2024
PIP Number MHRA-101447-PIP01-24-M01 (update) Active Substance
  • DIFELIKEFALIN ACETATE
 Conditions / Indications
  • Treatment of chronic kidney disease associated pruritus.
 Invented Name
  • Kapruvia
 Therapeutic area
  • Other: Nephrology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 06/11/2024
PIP Number MHRA-100959-PIP01-23-M02 (update) Active Substance
  • DOSTARLIMAB
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
 Invented Name
  • Jemperli
  • Jemperli
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 29/10/2024
PIP Number MHRA-100623-PIP01-22-M02 (update) Active Substance
  • NIRAPARIB TOSYLATE MONOHYDRATE
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
Invented Name
  • Zejula
  • Zejula
  • Zejula
  • Zejula
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 29/10/2024
PIP Number MHRA-100448-PIP01-22-M01 (update) Active Substance
  • RUXOLITINIB PHOSPHATE
 Conditions / Indications
  • Vitiligo
 Invented Name
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
 Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 29/10/2024
PIP Number MHRA-100183-PIP01-21-M03 (update) Active Substance
  • AZILSARTAN MEDOXOMIL
 Conditions / Indications
  • Treatment of hypertension
 Invented Name
  • Edarbi
  • Edarbi
  • Edarbi
Therapeutic area
  • Cardiovascular Diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 29/10/2024
PIP Number MHRA-100623-PIP01-22-M02 (update) Active Substance
  • NIRAPARIB TOSYLATE MONOHYDRATE
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
Invented Name
  • Zejula
  • Zejula
  • Zejula
  • Zejula
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 29/10/2024
PIP Number MHRA-100993-PIP01-23-M02 (update) Active Substance
  • QUIZARTINIB DIHYDROCHLORIDE
 Conditions / Indications
  • Treatment of acute myeloid leukaemia
 Invented Name
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
  • VANFLYTA
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 28/10/2024
PIP Number MHRA-101021-PIP01-23-M02 (update) Active Substance
  • FILGOTINIB MALEATE
 Conditions / Indications
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic arthritis).
 Invented Name
  • Jyseleca
 Therapeutic area
  • Immunology -Rheumatology-Transplantation
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 28/10/2024
PIP Number MHRA-100111-PIP01-21-M01 (update) Active Substance
  • Islatravir
  • DORAVIRINE
 Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
 Invented Name Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 28/10/2024
PIP Number MHRA-101493-PIP01-24 Active Substance
  • anti-alpha-synuclein recombinant humanised monoclonal antibody (Company code UCB7853)
 Conditions / Indications
  • Treatment of Parkinson's disease
 Invented Name Therapeutic area
  • Neurology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 28/10/2024
PIP Number MHRA-100482-PIP01-22-M02 (update) Active Substance
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
Conditions / Indications
  • Treatment of Niemann-Pick Disease Type C (NPC)
 Invented Name
  • Aqneursa
 Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 28/10/2024
PIP Number MHRA-101630-PIP01-24-M01 (update) Active Substance
  • LISOCABTAGENE MARALEUCEL
 Conditions / Indications
  • Treatment of B-lymphoblastic leukaemia/lymphoma
  • Treatment of mature B-cell neoplasm
Invented Name
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Breyanzi
 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 28/10/2024
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