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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-100080-PIP01-21 Active Substance
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
 Conditions / Indications
  • Treatment of Immune Thrombocytopenic Purpura
 Invented Name Therapeutic area
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100160-PIP01-21-M01 (update) Active Substance
  • TOCILIZUMAB
 Conditions / Indications
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
Invented Name
  • RoActemra
  • RoActemra
 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 17/12/2021
PIP Number MHRA-100154-PIP01-21-M01 (update) Active Substance
  • Cotadutide
Conditions / Indications
  • Treatment of Type 2 Diabetes Mellitus
 Invented Name
  • Not available at present
 Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100142-PIP01-21 Active Substance
  • Synthetic Hypericin
 Conditions / Indications
  • Treatment of cutaneous T-cell lymphoma
 Invented Name
  • HyBryte
 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 17/12/2021
PIP Number MHRA-100148-PIP01-21-M01 (update) Active Substance
  • LENVATINIB MESILATE
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms
 Invented Name
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
 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 17/12/2021
PIP Number MHRA-100128-PIP01-21-M01 (update) Active Substance
  • bis-choline tetrathiomolybdate
 Conditions / Indications
  • Treatment of Wilson disease
 Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100131-PIP01-21 Active Substance
  • ATEZOLIZUMAB
 Conditions / Indications
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
 Invented Name
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
 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 17/12/2021
PIP Number MHRA-100111-PIP01-21 Active Substance
  • DORAVIRINE
  • Islatravir
 Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection.
 Invented Name 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 17/12/2021
PIP Number MHRA-100098-PIP01-21-M01 (update) Active Substance
  • ATALUREN
 Conditions / Indications
  • Treatment of dystrophinopathy
Invented Name
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
  • Translarna
 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 17/12/2021
PIP Number MHRA-100097-PIP01-21-M01 (update) Active Substance
  • eladocagene exuparvovec
 Conditions / Indications
  • Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
 Invented Name
  • Upstaza
 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 17/12/2021
PIP Number MHRA-100095-PIP01-21-M01 (update) Active Substance
  • DORAVIRINE
 Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
 Invented Name
  • Pifeltro
 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 17/12/2021
PIP Number MHRA-100094-PIP01-21-M01 (update) Active Substance
  • DORAVIRINE
  • LAMIVUDINE
  • TENOFOVIR DISOPROXIL FUMARATE
 Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
 Invented Name
  • Delstrigo
 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 17/12/2021
PIP Number MHRA-100081-PIP01-21 Active Substance
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
 Conditions / Indications
  • Treatment of Chronic Kidney Disease
 Invented Name
  • Not available at present
 Therapeutic area
  • Other: Renal Disease
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100074-PIP01-21 Active Substance
  • GABAPENTIN
 Conditions / Indications
  • Treatment of Postherpetic Neuralgia
 Invented Name
  • Gralise
 Therapeutic area
  • Neurology
  • Pain
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100040-PIP01-21-M01 (update) Active Substance
  • Cotadutide
 Conditions / Indications
  • Treatment of Type 2 Diabetes Mellitus
 Invented Name Therapeutic area
  • Endocrinology-Gynaecology-Fertility-metabolism
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100102-PIP01-21-M01 (update) Active Substance
  • MOMETASONE FUROATE
  • INDACATEROL ACETATE
 Conditions / Indications
  • Treatment of asthma
 Invented Name
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
 Therapeutic area
  • Pneumology - Allergology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published 17/12/2021
PIP Number MHRA-100235-PIP01-21-M01 (update) Active Substance
  • Sotrovimab
 Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
 Invented Name
  • Xevudy
 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 03/12/2021
PIP Number MHRA-100152-PIP01-21 Active Substance
  • cosibelimab
 Conditions / Indications
  • Treatment of cutaneous squamous cell 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 03/12/2021
PIP Number MHRA-100092-PIP01-21-M01 (update) Active Substance
  • VENETOCLAX
 Conditions / Indications
  • Haematopoietic and lymphoid malignant neoplasms
  • Treatment of solid tumour malignant neoplasms
 Invented Name 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 03/12/2021
PIP Number MHRA-100024-PIP01-21-M01 (update) Active Substance
  • LAROTRECTINIB
 Conditions / Indications
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
 Invented Name
  • VITRAKVI
 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 03/12/2021
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