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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-100019-PIP01-21	2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT	Treatment of chronic Graft versus Host Disease (cGVHD)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/10/2022
MHRA-100487-PIP01-22	exebacase	Treatment of Staphylococcus aureus bacteraemia		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100473-PIP01-22	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100332-PIP01-21	sotatercept	Treatment of pulmonary arterial hypertension		Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100382-PIP01-21	RAVULIZUMAB	Treatment of myasthenia gravis	Ultomiris Ultomiris Ultomiris Ultomiris	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100335-PIP01-21	erdafitinib	Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)	BALVERSA BALVERSA ERFANDEL BALVERSA	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100218-PIP01-21	DUPILUMAB	Treatment of chronic spontaneous urticaria	Dupixent Dupixent	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100226-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154	Treatment of chronic idiopathic arthritis (rheumatoid, psoriatic, JIA, ankylosing spondylitis)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100178-PIP01-21	DTX401 (a nonreplicating, recombinant adeno-associated virus serotype 8 vector that contains a codon-optimized, wild-type human glucose-6-phosphatase (G6PC) gene)	Treatment of glycogen storage disease type 1a (GSDIa)	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100141-PIP01-21	BENRALIZUMAB	Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN	Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100151-PIP01-21	CANNABIDIOL	Treatment of epilepsy with myoclonic-atonic seizures (EMAS)	Epidyolex Epidyolex Epidyolex Epidiolex Epidyolex Epidyolex Epidiolex	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100105-PIP01-21	ALPRAZOLAM	Treatment of epileptic seizures		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100115-PIP01-21	Dersimelagon	Treatment of erythropoietic protoporphyria Treatment of X-linked protoporphyria	Not available at present	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100409-PIP01-21	autologous dendritic cells pulsed with autologous tumour cell lysate	Treatment of high grade glioma		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		27/09/2022
MHRA-100448-PIP01-22	RUXOLITINIB PHOSPHATE	Treatment of vitiligo	OPZELURA	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100312-PIP01-21	Ritlectinib	Treatment of alopecia areata		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Partial Compliance Check Granted	29/07/2022
MHRA-100330-PIP01-21	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)		Other: Metabolic disorders	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100315-PIP01-21	Brensocatib	Treatment of non‐cystic fibrosis bronchiectasis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100364-PIP01-21	Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01	Prevention of lower respiratory tract disease caused by respiratory syncytial virus	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022
MHRA-100304-PIP01-21	rozibafusp alfa	Treatment of systemic lupus erythematosus (SLE)	Not available at present	Immunology -Rheumatology-Transplantation Other: Inflammation-Rheumatology SLE	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		29/07/2022

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