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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100677-PIP01-22-M01 (update)	COBICISTAT	Treatment of human immunodeficiency virus type-1 (HIV-1) infection	Tybost Tybost	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100778-PIP01-22-M01 (update)	GUSELKUMAB	Treatment of ulcerative colitis	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100690-PIP01-22-M01 (update)	IMIPENEM MONOHYDRATE CILASTATIN SODIUM RELEBACTAM MONOHYDRATE	Treatment of infections caused by gram-negative organisms.	RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO RECARBRIO	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100330-PIP01-21 -M01 (update)	Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)	Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)	Not available at present	Other: Metabolic disorders	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100268-PIP01-21-M03 (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	24/08/2023
MHRA-100268-PIP01-21-M02 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100750-PIP01-22-M01 (update)	setrusumab	Treatment of osteogenesis imperfecta		Other: Skeletal	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100276-PIP01-21-M02 (update)	BRODALUMAB	Treatment of psoriasis	Kyntheum Lumicef Siliq	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100807-PIP01-22-M01 (update)	RIMEGEPANT SULFATE	Treatment of migraine headaches	Vydura	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100687-PIP01-22-M01 (update)	OBINUTUZUMAB	Treatment of systemic lupus erythematosus	Gazyvaro Gazyvaro	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100297-PIP01-21-M01 (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	24/08/2023
MHRA-100738-PIP01-22	PEMIGATINIB	Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement	Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre Pemazyre	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100641-PIP01-22-M02 (update)	DURVALUMAB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)	IMFINZI IMFINZI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	14/08/2023
MHRA-100740-PIP01-22	Xevinapant	Treatment of head and neck epithelial malignant neoplasms	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/06/2023
MHRA-100148-PIP01-21-M03 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma	Lenvima Lenvima Kisplyx Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100164-PIP01-21-M02 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of Coronavirus Disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100717-PIP01-22-M01 (update)	RISDIPLAM	Treatment of spinal muscular atrophy	Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi Evrysdi	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100130-PIP01-21-M02 (update)	BUPIVACAINE	Postsurgical analgesia	EXPAREL liposomal EXPAREL EXPAREL EXPAREL EXPAREL	Pain	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023
MHRA-100029-PIP01-21-M01 (update)	RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE COVID-19 vaccine (Ad26.COV2-S [recombinant])	Prevention of coronavirus disease-2019 (COVID-19)	COVID-19 vaccine Janssen Jcovden (previously COVID-19 Vaccine Janssen)	Infectious diseases Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/06/2023
MHRA-100351-PIP01-21-M01 (update)	DOLUTEGRAVIR RILPIVIRINE	Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.	JULUCA JULUCA JULUCA JULUCA JASUPA Juluca 50mg/25mg film-coated tablets JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA JULUCA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/06/2023

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