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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100198-PIP01-21-M01 (update)
  • RURIOCTOCOG ALFA PEGOL
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
  • Adynovi
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100284-PIP01-21-M01 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Other: Muscle disorders
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100283-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100286-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100321-PIP01-21-M01 (update)
  • GUSELKUMAB
  • Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100300-PIP01-21-M01 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of HIV-1 Infection
  • REZOLSTA
  • REZOLSTA
  • REZOLSTA
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100325-PIP01-21-M01 (update)
  • NALDEMEDINE
  • Treatment of opioid-induced constipation
  • Rizmoic
  • Rizmoic
  • SYMPROIC
  • SYMPROIC
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100343-PIP01-21-M01 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • systemic sclerosis
  • idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100334-PIP01-21-M01 (update)
  • INDACATEROL ACETATE
  • GLYCOPYRRONIUM BROMIDE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100268-PIP01-21-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100187-PIP01-21-M02 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100176-PIP01-21
  • favezelimab
  • PEMBROLIZUMAB
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma)
  • Neoplasms of CNS
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100246-PIP01-21
  • MK-1026
  • Treatment of mature B-cell malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100326-PIP01-21
  • GEMCITABINE HYDROCHLORIDE
  • Treatment of urothelial carcinoma
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100311-PIP01-21
  • Cetrelimab
  • Treatment of urothelial carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100384-PIP01-21
  • datopotamab deruxtecan
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100385-PIP01-21
  • datopotamab deruxtecan
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100386-PIP01-21
  • patritumab deruxtecan
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100480-PIP01-22
  • (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide
  • Treatment of mature B-cell malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100516-PIP01-22
  • Toripalimab
  • Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).
  • Not available at present
  • TUOYI
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 03/11/2022
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