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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-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-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-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-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-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-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-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-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-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-100347-PIP01-21	Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)	Prevention of lower respiratory track disease caused by RSV via maternal immunisation.	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100239-PIP01-21	multivalent pneumococcal polysaccharide conjugate vaccine	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100069-PIP01-21	RIBOCICLIB	Treatment of neuroblastoma	KISQALI KISQALI	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100470-PIP01-22	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100372-PIP01-21	concizumab	Treatment of congenital haemophilia A Treatment of congenital haemophilia B	Not available at present	Haematology-Hemostaseology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100355-PIP02-22	Fenebrutinib	Treatment of multiple sclerosis		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
MHRA-100234-PIP01-21	(S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide	Treatment of dilated cardiomyopathy due to lamin A/C gene mutations		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100075-PIP01-21	leniolisib	Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)	Not available at present	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	02/11/2022
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-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	21/10/2022
MHRA-100243-PIP01-21	DAPAGLIFLOZIN 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)	Prevention of cardiovascular events in patients with chronic heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	21/10/2022

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