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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100100-PIP01-21	Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein	Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100062-PIP01-21	(14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate TEZACAFTOR DEUTIVACAFTOR	Treatment of Cystic Fibrosis		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100091-PIP01-21	Rozanolixizumab	Treatment of Immune thrombocytopenia	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100027-PIP01-21	benzylamine derivative of benzofuran	Treatment of paroxysmal nocturnal haemoglobinuria (PNH)		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	29/07/2022
MHRA-100324-PIP01-21	Loncastuximab tesirine	Treatment of mature B-cell neoplasms	Zynlonta Zynlonta	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100346-PIP01-21	molnupiravir	Prevention of coronavirus disease 2019 (COVID-19)	Lagevrio Lagevrio	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100381-PIP01-21	Regdanvimab	Treatment of coronavirus disease 2019 (COVID-19)	Regkirona Regkirona Inj.	Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100275-PIP01-21	SEMAGLUTIDE	Treatment of non-alcoholic steatohepatitis (NASH)	Ozempic OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Ozempic Ozempic Ozempic Ozempic OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN	Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100208-PIP01-21	Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain	Treatment of non-alcoholic steatohepatitis		Gastroenterology-Hepatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100230-PIP01-21	Thienopyrimidine Derivative	Treatment of fibrosing interstitial lung disease		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100254-PIP01-21	epcoritamab	Treatment of mature B-cell malignancies	Not available at present	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100291-PIP01-21	imetelstat	Treatment of acute myeloid leukaemia Treatment of Myelodysplastic Syndromes (MDS), including JMML		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100179-PIP01-21	vemircopan	Treatment of paroxysmal nocturnal haemoglobinuria		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100196-PIP01-21	SARS-CoV-2 virus, beta-propiolactone inactivated	Prevention of coronavirus disease 2019 (COVID-19)	Not available	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100232-PIP01-21	ALECTINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	Alecensa Alecensa	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100140-PIP01-21	BENRALIZUMAB	Treatment of Hypereosinophilic syndrome (HES)	FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100106-PIP01-21	3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde sodium chloride solution 4.2% (w/v)	Treatment of primary ciliary dyskinesia		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100150-PIP01-21	AZITHROMYCIN	Prevention of bronchopulmonary dysplasia (BPD)		Pneumology - Allergology Neonatology - Paediatric Intensive Care	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022
MHRA-100050-PIP01-21	efgartigimod alfa	Treatment of Immune thrombocytopenia		Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/05/2022

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