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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100829-PIP01-22	Edaravone	Treatment of Amyotrophic lateral sclerosis	Not available at this moment	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100927-PIP01-23	Namilumab	Treatment of sarcoidosis	Not available at present	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100850-PIP01-23	deucravacitinib	Treatment of Sjogren's Syndrome	SOTYKTU SOTYKTU SOTYKTU SOTYKTU SOTYKTU	Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100874-PIP01-23	PEMBROLIZUMAB	Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue) Treatment of Hodgkin lymphoma	Keytruda	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100848-PIP01-23	messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene	Treatment for transthyretin amyloidosis (ATTR)	Not available at present	Neurology Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100873-PIP01-23	Meningococcal Group A, C, W-135 and Y conjugate vaccine	Meningococcal meningitis	Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-101019-PIP01-23	Treprostinil Palmitil	Treatment of pulmonary hypertension due to lung disease and/or hypoxia.	Not available at present	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100933-PIP01-23	camlipixant	Treatment of unexplained or chronic refractory cough		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100102-PIP01-21-M02 (update)	INDACATEROL ACETATE MOMETASONE FUROATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	25/08/2023
MHRA-100095-PIP01-21-M03 (update)	DORAVIRINE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Pifeltro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100094-PIP01-21-M02 (update)	DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Delstrigo	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100786-PIP01-22-M01 (update)	TOFACITINIB CITRATE	Treatment of ulcerative colitis	XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ XELJANZ	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100832-PIP01-23-M01 (update)	LANADELUMAB	Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).	TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100212-PIP01-21-M02 (update)	FINERENONE	Treatment of Chronic Kidney Disease	Kerendia Kerendia	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100776-PIP01-22-M01 (update)	Nemolizumab	Treatment of atopic dermatitis.	Not yet defined	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100676-PIP01-22-M01 (update)	EMTRICITABINE TENOFOVIR ALAFENAMIDE FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection.	Descovy Descovy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	24/08/2023
MHRA-100801-PIP01-22	eplontersen	Treatment of transthyretin-mediated amyloidosis	Not available at present	Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100806-PIP01-22	ALPELISIB	Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours) Treatment of Peritoneal cancer (excluding blastomas and sarcomas).	Piqray Piqray	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100301-PIP02-22	Nipocalimab	Treatment of Bullous Pemphigoid		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023

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