338 candidates

Every drug in the RareDiseaseHedge “Funnel A” screen: a real marketing authorisation from a foreign regulator (EMA, EEA national, Health Canada, Swissmedic, PMDA) whose active moiety has never been approved in the United States — the population FD&C Act §529 makes eligible for a rare-pediatric Priority Review Voucher. Sorted by how many EEA countries authorise the drug (widest reach first).

Data snapshot: UNII 4Aug2026 · Drugs@FDA 12 Oct 2026 · Orange Book 12 Oct 2026 · EMA 12 Oct 2026 · Health Canada 12 Oct 2026 · Swissmedic 12 Oct 2026 · PMDA 12 Oct 2026 · GSRS relationship graph. Generated 2026-10-12. Also available as plain text and raw JSON; the interactive version with the per-candidate §529 checklist is on the almanac and the card list.

Drug / moiety	Disease	Indication	Approved by	EEA countries	Status	Flags	ATC	Papers	Trials	§529 verdict
Etoricoxib `ETORICOXIB`	Rheumatic Diseases		EEA national	30	authorised	—	—	12	129	likely eligible pending review
Fusidic Acid `FUSIDIC`	—		EEA national	30	authorised	—	—	55	27	likely eligible pending review
Rupatadine `RUPATADINE`	Hypersensitivity		EEA national	30	authorised	—	—	7	15	likely eligible pending review
Vildagliptin `VILDAGLIPTIN`	Diabetes Mellitus, Type 2	Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).	EMA, EEA national	30	authorised	US filed & refused, multi-regulator	A10BH02	0	209	likely eligible pending review
Alfacalcidol `ALFACALCIDOL`	Osteoporosis; Muscular Diseases; Osteoporosis, Postmenopausal; Pelvic Organ Prolapse		EEA national, Health Canada	29	authorised	multi-regulator	—	31	52	likely eligible pending review
Amorolfine `AMOROLFINE`	Onychomycosis		EEA national	29	authorised	—	—	2	13	likely eligible pending review
Bilastine `BILASTINE`	Eye Manifestations; Hypersensitivity		EEA national, Health Canada	29	authorised	multi-regulator	—	12	28	likely eligible pending review
Xylometazoline `XYLOMETAZOLINE`	Eye Manifestations; Nasal Obstruction		EEA national	29	authorised	—	—	10	37	likely eligible pending review
Zuclopenthixol `ZUCLOPENTHIXOL`	Psychotic Disorders; Anxiety; Dementia; Depressive Disorder; Schizophrenia		EEA national, Health Canada	29	authorised	multi-regulator	—	3	10	likely eligible pending review
Benzydamine `BENZYDAMINE`	Rheumatic Diseases; Vaginitis; Arthralgia; Myalgia		EEA national	28	authorised	—	—	10	49	likely eligible pending review
Bromhexine `BROMHEXINE`	—		EEA national	28	authorised	—	—	10	30	likely eligible pending review
Moxonidine `MOXONIDINE`	Hypertension		EEA national	28	authorised	—	—	2	21	likely eligible pending review
Ambroxol `AMBROXOL`	Respiratory Tract Diseases; Pharyngitis; Parkinson Disease		EEA national	27	authorised	—	—	40	40	likely eligible pending review
Etofenamate `ETOFENAMATE`	—		EEA national	27	authorised	—	—	0	2	likely eligible pending review
Gliclazide `GLICLAZIDE`	Diabetes Mellitus		EEA national, Health Canada	27	authorised	multi-regulator	—	8	85	likely eligible pending review
Levosimendan `LEVOSIMENDAN`	Heart Failure; ST Elevation Myocardial Infarction; Cardiovascular Diseases; Shock; Amyotrophic Lateral Sclerosis		EEA national	27	authorised	EU orphan designation	—	117	118	likely eligible pending review
Cyproterone `CYPROTERONE`	—		EEA national	26	authorised	—	—	33	66	likely eligible pending review
Dapoxetine `DAPOXETINE`	Erectile Dysfunction; Sexual Dysfunction, Physiological; Premature Ejaculation		EEA national	26	authorised	—	—	1	33	likely eligible pending review
Mebeverine `MEBEVERINE`	Digestive System Diseases		EEA national	26	authorised	—	—	2	20	likely eligible pending review
Racecadotril `RACECADOTRIL`	Diarrhea; Diarrhea, Infantile		EEA national	26	authorised	—	—	23	15	likely eligible pending review
Tibolone `TIBOLONE`	Osteoporosis; Sexual Dysfunction, Physiological; Breast Neoplasms; Menopause		EEA national	26	authorised	—	—	2	28	likely eligible pending review
Cytisinicline `CYTISINICLINE`	Tobacco Use Disorder; Smoking Cessation		EEA national	25	authorised	US filed & refused	—	0	34	likely eligible pending review
Fenticonazole `FENTICONAZOLE`	—		EEA national	25	authorised	—	—	0	2	likely eligible pending review
Atosiban `ATOSIBAN`	Obstetric Labor, Premature	Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: regular uterine contractions of at least 30 seconds’ duration at a rate of ? 4 per 30 minutes; a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ? 50%; a gestational age from 24 until 33 completed weeks; a normal foetal heart rate.	EMA, EEA national	24	authorised	multi-regulator	G02CX01	7	23	likely eligible pending review
Bromazepam `BROMAZEPAM`	Anxiety		EEA national, Health Canada	24	authorised	multi-regulator	—	6	5	likely eligible pending review
Piracetam `PIRACETAM`	Attention Deficit Disorder with Hyperactivity		EEA national	24	authorised	—	—	17	16	likely eligible pending review
Carbetocin `CARBETOCIN`	Postpartum Hemorrhage; Prader-Willi Syndrome		EEA national	23	authorised	EU orphan designation	—	2	103	likely eligible pending review
Domperidone `DOMPERIDONE`	Digestive System Diseases		EEA national	23	authorised	—	—	49	83	likely eligible pending review
Flucloxacillin `FLUCLOXACILLIN`	—		EEA national	23	authorised	—	—	62	33	likely eligible pending review
Itopride `ITOPRIDE`	Dyspepsia; Peritonitis; Digestive System Diseases		EEA national	23	authorised	—	—	0	33	likely eligible pending review
Aceclofenac `ACECLOFENAC`	Rheumatic Diseases; Myalgia; Arthralgia; Arthritis, Rheumatoid; Spondylitis; Osteoarthritis		EEA national	22	authorised	—	—	3	22	likely eligible pending review
Agomelatine `AGOMELATINE`	Depressive Disorder, Major	Treatment of major depressive episodes in adults.	EMA, EEA national	22	authorised	multi-regulator	N06AX22	9	27	likely eligible pending review
Trimetazidine `TRIMETAZIDINE`	Cardiovascular Diseases		EEA national	22	authorised	—	—	3	40	likely eligible pending review
Mianserin `MIANSERIN`	Depressive Disorder		EEA national	21	authorised	—	—	3	5	likely eligible pending review
Carbocysteine `CARBOCISTEINE`	—		EEA national	20	authorised	—	—	3	10	likely eligible pending review
Iobitridol `IOBITRIDOL`	—		EEA national	20	authorised	—	—	5	9	likely eligible pending review
Nitrazepam `NITRAZEPAM`	Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia		EEA national	20	authorised	—	—	20	12	likely eligible pending review
Sertindole `SERTINDOLE`	Psychotic Disorders		EEA national	20	authorised	—	—	9	17	likely eligible pending review
Sulthiame `SULTIAME`	—		EEA national	20	authorised	—	—	0	5	likely eligible pending review
Diosmin `DIOSMIN`	Cardiovascular Diseases		EEA national	19	authorised	—	—	1	55	likely eligible pending review
Ebastine `EBASTINE`	Hypersensitivity		EEA national	19	authorised	—	—	4	10	likely eligible pending review
Zofenopril `ZOFENOPRIL`	—		EEA national	19	authorised	—	—	1	6	likely eligible pending review
Hexetidine `HEXETIDINE`	Infections		EEA national	18	authorised	—	—	0	5	likely eligible pending review
Lacidipine `LACIDIPINE`	Cardiovascular Diseases		EEA national	18	authorised	—	—	1	15	likely eligible pending review
Urapidil `URAPIDIL`	Hypertension; Pre-Eclampsia; Stroke; Cerebrovascular Disorders		EEA national	18	authorised	—	—	2	32	likely eligible pending review
Butamirate `BUTAMIRATE`	—		EEA national	17	authorised	—	—	2	2	likely eligible pending review
Hexamidine `HEXAMIDINE`	Nasal Obstruction; Eye Infections		EEA national	17	authorised	—	—	1	2	likely eligible pending review
Erdosteine `ERDOSTEINE`	Pulmonary Disease, Chronic Obstructive		EEA national	16	authorised	EU orphan designation	—	5	10	likely eligible pending review
Meldonium `MELDONIUM`	—		EEA national	16	authorised	—	—	1	7	likely eligible pending review
Moclobemide `MOCLOBEMIDE`	Depressive Disorder		EEA national	16	authorised	—	—	2	9	likely eligible pending review
Tramazoline `TRAMAZOLINE`	—		EEA national	16	authorised	—	—	0	2	likely eligible pending review
Bezafibrate `BEZAFIBRATE`	Cardiovascular Diseases		EEA national	15	authorised	EU orphan designation	—	10	27	likely eligible pending review
Octenidine `OCTENIDINE`	—		EEA national	15	authorised	—	—	2	29	likely eligible pending review
Roxithromycin `ROXITHROMYCIN`	Bacterial Infections		EEA national	15	authorised	—	—	31	11	likely eligible pending review
Somatostatin `SOMATOSTATIN`	Carcinoma, Hepatocellular; Hypertension, Portal; Gallbladder Neoplasms; Neuroendocrine Tumors; Polycystic Kidney, Autosomal Dominant; Pancreatitis		EEA national	15	authorised	US filed & refused	—	503	359	likely eligible pending review
Tiapride `TIAPRIDE`	Anxiety; Dementia; Tourette Syndrome; Psychotic Disorders; Depressive Disorder; Schizophrenia		EEA national	15	authorised	—	—	11	5	likely eligible pending review
Benfotiamine `BENFOTIAMINE`	Diabetic Neuropathies		EEA national	14	authorised	—	—	2	21	likely eligible pending review
Levodropropizine `LEVODROPROPIZINE`	Cough; Bronchial Diseases		EEA national	14	authorised	—	—	9	10	likely eligible pending review
Lymecycline `LYMECYCLINE`	Bacterial Infections		EEA national	14	authorised	—	—	1	6	likely eligible pending review
Nimesulide `NIMESULIDE`	Rheumatic Diseases; Arthralgia; Myalgia		EEA national	14	authorised	—	—	34	17	likely eligible pending review
Propiverine `PROPIVERINE`	Urinary Incontinence; Polyuria		EEA national, Health Canada	14	authorised	multi-regulator	—	15	17	likely eligible pending review
Reboxetine `REBOXETINE`	Depressive Disorder		EEA national	14	authorised	—	—	5	41	likely eligible pending review
Amsacrine `AMSACRINE`	Neoplasms		EEA national	13	authorised	—	—	16	11	likely eligible pending review
Calcium Dobesilate `CALCIUM DOBESILATE`	Varicose Veins		EEA national	13	authorised	—	—	0	806	likely eligible pending review
Propamidine `PROPAMIDINE`	Acanthamoeba Keratitis; Eye Infections		EEA national	13	authorised	—	—	4	1	likely eligible pending review
Rilmenidine `RILMENIDINE`	Hypertension		EEA national	13	authorised	—	—	1	2	likely eligible pending review
Tauroselcholic Acid `TAUROSELCHOLIC`	—		EEA national	13	authorised	—	—	0	0	likely eligible pending review
Carbimazole `CARBIMAZOLE`	Thyroid Diseases		EEA national	12	authorised	—	—	82	7	likely eligible pending review
Dothiepin `DOSULEPIN`	—		EEA national	12	authorised	—	—	1	3	likely eligible pending review
Ethamsylate `ETAMSILATE`	—		EEA national	12	authorised	—	—	0	0	likely eligible pending review
Gliquidone `GLIQUIDONE`	Diabetes Mellitus		EEA national	12	authorised	—	—	0	5	likely eligible pending review
Ipidacrine `IPIDACRINE`	—		EEA national	12	authorised	—	—	0	0	likely eligible pending review
Isoconazole `ISOCONAZOLE`	—		EEA national	12	authorised	—	—	3	1	likely eligible pending review
Lormetazepam `LORMETAZEPAM`	Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia		EEA national	12	authorised	—	—	0	6	likely eligible pending review
Troxerutin `TROXERUTIN`	Cardiovascular Diseases		EEA national	12	authorised	—	—	2	6	likely eligible pending review
Celiprolol `CELIPROLOL`	Cardiovascular Diseases		EEA national	11	authorised	—	—	3	4	likely eligible pending review
Choline Salicylate	Pain; Fever		EEA national	11	authorised	—	—	3	376	likely eligible pending review
Clodronic Acid `CLODRONATE`	—		EEA national	11	authorised	—	—	20	17	likely eligible pending review
Clomethiazole `CLOMETHIAZOLE`	Anxiety; Dementia; Depressive Disorder; Schizophrenia		EEA national	11	authorised	—	—	2	1	likely eligible pending review
Hydrotalcite `HYDROTALCITE`	—		EEA national	11	authorised	—	—	0	7	likely eligible pending review
Lornoxicam `LORNOXICAM`	Rheumatic Diseases		EEA national	11	authorised	—	—	4	21	likely eligible pending review
Tenoxicam `TENOXICAM`	Rheumatic Diseases		EEA national, Health Canada	11	authorised	multi-regulator	—	4	41	likely eligible pending review
Vinpocetine `VINPOCETINE`	Attention Deficit Disorder with Hyperactivity		EEA national	11	authorised	—	—	1	9	likely eligible pending review
Buserelin `BUSERELIN`	Neoplasms		EEA national	10	authorised	—	—	12	42	likely eligible pending review
Cilazapril `CILAZAPRIL`	Cardiovascular Diseases		EEA national	10	authorised	—	—	3	4	likely eligible pending review
Drotaverine `DROTAVERINE`	Digestive System Diseases; Bile Duct Diseases		EEA national	10	authorised	—	—	1	6	likely eligible pending review
Melperone `MELPERONE`	Psychotic Disorders; Anxiety; Dementia; Depressive Disorder; Schizophrenia		EEA national	10	authorised	—	—	0	4	likely eligible pending review
Quinagolide `QUINAGOLIDE`	—		EEA national	10	authorised	—	—	1	6	likely eligible pending review
Raltitrexed `RALTITREXED`	Neoplasms		EEA national	10	authorised	—	—	8	87	likely eligible pending review
Acemetacin `ACEMETACIN`	Rheumatic Diseases		EEA national	9	authorised	—	—	2	2	likely eligible pending review
Brivudine `BRIVUDINE`	—		EEA national	9	authorised	EU orphan designation	—	2	2	likely eligible pending review
Brotizolam `BROTIZOLAM`	Sleep Initiation and Maintenance Disorders; Anxiety; Dementia; Depressive Disorder; Sleep Wake Disorders; Schizophrenia		EEA national	9	authorised	—	—	1	10	likely eligible pending review
Etilefrine `ETILEFRINE`	Cardiovascular Diseases		EEA national	9	authorised	EU orphan designation	—	7	2	likely eligible pending review
Flunarizine `FLUNARIZINE`	Vertigo		EEA national	9	authorised	—	—	53	21	likely eligible pending review
Nicergoline `NICERGOLINE`	Cardiovascular Diseases		EEA national	9	authorised	—	—	1	6	likely eligible pending review
Tacalcitol `TACALCITOL`	Psoriasis		EEA national	9	authorised	—	—	1	2	likely eligible pending review
Temocillin `TEMOCILLIN`	Urinary Tract Infections; Bacterial Infections; Bacteremia		EEA national	9	authorised	—	—	5	16	likely eligible pending review
Chloroxylenol `CHLOROXYLENOL`	Inflammation		EEA national	8	authorised	—	—	0	9	likely eligible pending review
Flunitrazepam `FLUNITRAZEPAM`	—		EEA national	8	authorised	—	—	19	2	likely eligible pending review
Lynestrenol `LYNESTRENOL`	—		EEA national	8	authorised	—	—	6	4	likely eligible pending review
Magaldrate `MAGALDRATE`	—		EEA national	8	authorised	—	—	0	4	likely eligible pending review
Metildigoxin `METILDIGOXIN`	Cardiovascular Diseases		EEA national	8	authorised	—	—	0	0	likely eligible pending review
Naftidrofuryl `NAFTIDROFURYL`	—		EEA national	8	authorised	—	—	1	0	likely eligible pending review
Thiocolchicoside `THIOCOLCHICOSIDE`	Low Back Pain		EEA national	8	authorised	—	—	3	15	likely eligible pending review
Benzocaine `BENZOCAINE`	Pruritus; Anesthesia; Hemorrhoids; Pharyngitis; Sunburn; Burns		EEA national	7	authorised	—	—	49	7250	likely eligible pending review
Citicoline `CITICOLINE`	Stroke; Amphetamine-Related Disorders; Attention Deficit Disorder with Hyperactivity; Cerebral Infarction; Brain Ischemia; Brain Injuries		EEA national	7	authorised	—	—	6	72	likely eligible pending review
Myrtecaine `MYRTECAINE`	—		EEA national	7	authorised	—	—	0	0	likely eligible pending review
Niflumic Acid `NIFLUMIC`	—		EEA national	7	authorised	—	—	9	1	likely eligible pending review
Pipamperone `PIPAMPERONE`	Psychotic Disorders; Anxiety; Dementia; Depressive Disorder, Major; Depressive Disorder; Schizophrenia		EEA national	7	authorised	—	—	3	6	likely eligible pending review
Piribedil `PIRIBEDIL`	—		EEA national	7	authorised	—	—	0	5	likely eligible pending review
Piritramide `PIRITRAMIDE`	Pain		EEA national	7	authorised	—	—	18	25	likely eligible pending review
Pizotyline `PIZOTIFEN`	—		EEA national	7	authorised	—	—	8	2	likely eligible pending review
Sulprostone `SULPROSTONE`	—		EEA national	7	authorised	—	—	8	5	likely eligible pending review
Canrenoate Potassium `POTASSIUM CANRENOATE`	—		EEA national	6	authorised	—	—	2	20	likely eligible pending review
Cinolazepam `CINOLAZEPAM`	—		EEA national	6	authorised	—	—	0	0	likely eligible pending review
Diflucortolone `DIFLUCORTOLONE`	—		EEA national	6	authorised	—	—	4	3	likely eligible pending review
Flutrimazole `FLUTRIMAZOLE`	—		EEA national	6	authorised	—	—	0	0	likely eligible pending review
Imidapril `IMIDAPRIL`	Cardiovascular Diseases		EEA national	6	authorised	—	—	0	5	likely eligible pending review
Levosulpiride `LEVOSULPIRIDE`	—		EEA national	6	authorised	—	—	2	5	likely eligible pending review
Loprazolam `LOPRAZOLAM`	—		EEA national	6	authorised	—	—	0	0	likely eligible pending review
Mesterolone `MESTEROLONE`	—		EEA national	6	authorised	—	—	1	0	likely eligible pending review
Nifuratel `NIFURATEL`	—		EEA national	6	authorised	—	—	4	0	likely eligible pending review
Nomegestrol `NOMEGESTROL`	—		EEA national	6	authorised	—	—	0	22	likely eligible pending review
Pridinol `PRIDINOL`	—		EEA national	6	authorised	—	—	0	1	likely eligible pending review
Tofisopam `TOFISOPAM`	—		EEA national	6	authorised	—	—	1	2	likely eligible pending review
Triflusal `TRIFLUSAL`	Thrombosis		EEA national	6	authorised	—	—	0	6	likely eligible pending review
Ubidecarenone `UBIDECARENONE`	Cardiovascular Diseases; Pre-Eclampsia; Fatigue Syndrome, Chronic; Multiple Organ Failure		EEA national	6	authorised	—	—	0	285	likely eligible pending review
Chloropyramine `CHLOROPYRAMINE`	—		EEA national	5	authorised	—	—	3	1	likely eligible pending review
Ciprofibrate `CIPROFIBRATE`	Cardiovascular Diseases		EEA national	5	authorised	—	—	1	4	likely eligible pending review
Enoximone `ENOXIMONE`	Cardiovascular Diseases		EEA national	5	authorised	—	—	20	8	likely eligible pending review
Medazepam `MEDAZEPAM`	Anxiety		EEA national	5	authorised	—	—	3	2	likely eligible pending review
Mizolastine `MIZOLASTINE`	Hypersensitivity		EEA national	5	authorised	—	—	2	1	likely eligible pending review
Nicorandil `NICORANDIL`	Cardiovascular Diseases		EEA national	5	authorised	—	—	14	44	likely eligible pending review
Nifuroxazide `NIFUROXAZIDE`	Brain Diseases		EEA national	5	authorised	—	—	4	3	likely eligible pending review
Nitroxoline `NITROXOLINE`	Bacterial Infections		EEA national	5	authorised	—	—	0	0	likely eligible pending review
Sulbutiamine `SULBUTIAMINE`	—		EEA national	5	authorised	—	—	1	1	likely eligible pending review
Tolfenamic Acid `TOLFENAMIC`	—		EEA national	5	authorised	EU orphan designation	—	4	2	likely eligible pending review
Acipimox `ACIPIMOX`	Cardiovascular Diseases		EEA national	4	authorised	—	—	1	25	likely eligible pending review
Ademetionine `ADEMETIONINE`	Non-alcoholic Fatty Liver Disease; Cholestasis, Intrahepatic; Liver Diseases; Hepatitis		EEA national	4	authorised	—	—	0	69	likely eligible pending review
Alizapride `ALIZAPRIDE`	Digestive System Diseases		EEA national	4	authorised	—	—	3	3	likely eligible pending review
Antipyrine `PHENAZONE`	—		EEA national	4	authorised	—	—	2	47	likely eligible pending review
Barnidipine `BARNIDIPINE`	—		EEA national	4	authorised	—	—	0	2	likely eligible pending review
Biclotymol `BICLOTYMOL`	—		EEA national	4	authorised	—	—	0	0	likely eligible pending review
Bromperidol `BROMPERIDOL`	Psychotic Disorders		EEA national	4	authorised	—	—	0	3	likely eligible pending review
Carbenoxolone `CARBENOXOLONE`	Gastroesophageal Reflux; Peptic Ulcer		EEA national	4	authorised	—	—	19	0	likely eligible pending review
Cinitapride `CINITAPRIDE`	Dyspepsia; Digestive System Diseases		EEA national	4	authorised	—	—	1	1	likely eligible pending review
Clobetasone `CLOBETASONE`	—		EEA national	4	authorised	—	—	3	5	likely eligible pending review
Cloperastine `CLOPERASTINE`	—		EEA national	4	authorised	—	—	4	0	likely eligible pending review
Clotiazepam `CLOTIAZEPAM`	Anxiety		EEA national	4	authorised	—	—	0	1	likely eligible pending review
Diacerein `DIACEREIN`	Rheumatic Diseases		EEA national	4	authorised	EU orphan designation	—	4	39	likely eligible pending review
Dibrompropamidine `DIBROMPROPAMIDINE`	—		EEA national	4	authorised	—	—	0	1	likely eligible pending review
Ethyl Loflazepate `ETHYL LOFLAZEPATE`	—		EEA national	4	authorised	—	—	0	0	likely eligible pending review
Fenoterol `FENOTEROL`	Lung Diseases, Obstructive		EEA national	4	authorised	—	—	12	25	likely eligible pending review
Fluspirilene `FLUSPIRILENE`	Psychotic Disorders		EEA national	4	authorised	—	—	0	19	likely eligible pending review
Hexoprenaline `HEXOPRENALINE`	—		EEA national	4	authorised	—	—	1	0	likely eligible pending review
Hymecromone `HYMECROMONE`	—		EEA national	4	authorised	EU orphan designation	—	0	6	likely eligible pending review
Idebenone `IDEBENONE`	Optic Atrophy, Hereditary, Leber	Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).	EMA, EEA national	4	authorised	orphan, EU orphan designation, US filed & refused, multi-regulator	N06BX13	36	35	likely eligible pending review
Indobufen `INDOBUFEN`	Thrombosis; Atrial Fibrillation		EEA national	4	authorised	—	—	0	14	likely eligible pending review
Oxitriptan `OXITRIPTAN`	Depressive Disorder		EEA national	4	authorised	—	—	0	30	likely eligible pending review
Pefloxacin `PEFLOXACIN`	Bacterial Infections		EEA national	4	authorised	—	—	12	2	likely eligible pending review
Periciazine `PERICIAZINE`	Psychotic Disorders		EEA national	4	authorised	—	—	1	1	likely eligible pending review
Promestriene `PROMESTRIENE`	Hypospadias		EEA national	4	authorised	—	—	0	10	likely eligible pending review
Prothipendyl `PROTHIPENDYL`	Psychotic Disorders		EEA national	4	authorised	—	—	0	2	likely eligible pending review
Tolnaftate `TOLNAFTATE`	Infections; Tinea; Tinea Pedis; Pruritus		EEA national	4	authorised	—	—	1	34	likely eligible pending review
Vindesine `VINDESINE`	Neoplasms		EEA national	4	authorised	—	—	26	85	likely eligible pending review
Ambazone `AMBAZONE`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Bamipine `BAMIPINE`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Benzbromarone `BENZBROMARONE`	Gout		EEA national	3	authorised	—	—	3	13	likely eligible pending review
Bornaprine `BORNAPRINE`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Clebopride `CLEBOPRIDE`	Digestive System Diseases		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Clothiapine `CLOTIAPINE`	—		EEA national	3	authorised	—	—	1	2	likely eligible pending review
Cystine `L CYSTINE`	—		EEA national	3	authorised	—	—	4	31	likely eligible pending review
Delamanid `DELAMANID`	Tuberculosis	Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.	EMA, EEA national	3	authorised	rare disease, multi-regulator	J04AK06	40	44	likely eligible pending review
Ergonovine `ERGOMETRINE`	—		EEA national	3	authorised	—	—	3	27	likely eligible pending review
Ethacridine `ETHACRIDINE`	—		EEA national	3	authorised	—	—	0	2	likely eligible pending review
Etifoxine `ETIFOXINE`	Anxiety		EEA national	3	authorised	—	—	0	2	likely eligible pending review
Filgotinib `FILGOTINIB`	Arthritis, Rheumatoid	Rheumatoid arthritis Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Ulcerative colitis Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	L04AF04	11	66	likely eligible pending review
Fluprednidene `FLUPREDNIDENE`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Gefapixant `GEFAPIXANT`	Cough	Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	R05DB29	0	27	likely eligible pending review
Linzagolix `LINZAGOLIX`	Leiomyoma	Yselty is indicated in adult women of reproductive age for: -           treatment of moderate to severe symptoms of uterine fibroids,-           symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis (see section 5.1).	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	H01CC04	0	18	likely eligible pending review
Mifamurtide `MIFAMURTIDE`	Osteosarcoma	Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.	EMA, EEA national	3	authorised	rare disease, pediatric onset, EU orphan designation, US filed & refused, multi-regulator	L03AX15	16	8	likely eligible pending review
Nadifloxacin `NADIFLOXACIN`	Acne Vulgaris		EEA national	3	authorised	—	—	1	3	likely eligible pending review
Naftazone `NAFTAZONE`	Cardiovascular Diseases		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Opipramol `OPIPRAMOL`	Anxiety; Dementia; Depressive Disorder; Schizophrenia		EEA national	3	authorised	—	—	0	3	likely eligible pending review
Ornidazole `ORNIDAZOLE`	Bacterial Infections; Amebiasis		EEA national	3	authorised	—	—	6	9	likely eligible pending review
Oxaceprol `OXACEPROL`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Padeliporfin `PADELIPORFIN`	Neoplasms		EEA national	3	authorised	—	—	0	12	likely eligible pending review
Pentetreotide `PENTETREOTIDE`	—		EEA national	3	authorised	—	—	7	15	likely eligible pending review
Perflubutane `PERFLUBUTANE`	Ultrasonography	ultrasound imaging agent indicated for the detection of coronary artery disease (CAD)	EMA, EEA national	3	authorised	multi-regulator	V08D	2	20	likely eligible pending review
Pramiracetam `PRAMIRACETAM`	—		EEA national	3	authorised	—	—	0	0	likely eligible pending review
Prulifloxacin `PRULIFLOXACIN`	Bronchitis, Chronic; Urinary Tract Infections; Gastroenteritis; Bacterial Infections		EEA national	3	authorised	—	—	1	8	likely eligible pending review
Roxadustat `ROXADUSTAT`	Anemia;Kidney Failure, Chronic	Evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	B03XA05	5	66	likely eligible pending review
Terizidone `TERIZIDONE`	—		EEA national	3	authorised	—	—	3	4	likely eligible pending review
Tiaprofenic Acid `TIAPROFENIC`	—		EEA national	3	authorised	—	—	1	1	likely eligible pending review
Tolebrutinib `TOLEBRUTINIB`	Multiple Sclerosis, Chronic Progressive	Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	L04AA62	0	12	likely eligible pending review
Vernakalant `VERNAKALANT`	Atrial Fibrillation	Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: for non-surgery patients: atrial fibrillation </= 7 days duration; for post-cardiac surgery patients: atrial fibrillation </= 3 days duration.	EMA, EEA national	3	authorised	US filed & refused, multi-regulator	C01BG11	1	17	likely eligible pending review
Vinflunine `VINFLUNINE`	Carcinoma, Transitional Cell;Urologic Neoplasms	Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ? 2.	EMA, EEA national	3	authorised	multi-regulator	L01CA05	0	35	likely eligible pending review
Amylmetacresol `AMYLMETACRESOL`	—		EEA national, Health Canada	2	authorised	multi-regulator	—	0	1	likely eligible pending review
Azidamfenicol `AZIDAMFENICOL`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Bencyclane `BENCYCLANE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Benperidol `BENPERIDOL`	Psychotic Disorders		EEA national	2	authorised	—	—	2	4	likely eligible pending review
Chlormadinone `CHLORMADINONE`	—		EEA national	2	authorised	—	—	7	4	likely eligible pending review
Chlorphenoxamine `CHLORPHENOXAMINE`	Pruritus; Hypersensitivity		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Chlorquinaldol `CHLORQUINALDOL`	Amebiasis		EEA national	2	authorised	—	—	0	1	likely eligible pending review
Choline Alfoscerate `CHOLINE ALFOSCERATE`	Diabetes Mellitus, Type 2		EEA national	2	authorised	—	—	2	28	likely eligible pending review
Clopamide `CLOPAMIDE`	—		EEA national	2	authorised	—	—	1	0	likely eligible pending review
Clorophene `CLOROFENE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Cobamamide `COBAMAMIDE`	—		EEA national	2	authorised	—	—	0	3	likely eligible pending review
Cyamemazine `CYAMEMAZINE`	—		EEA national	2	authorised	—	—	1	1	likely eligible pending review
Dehydrocholic Acid `DEHYDROCHOLIC`	—		EEA national	2	authorised	—	—	5	0	likely eligible pending review
Dihydralazine `DIHYDRALAZINE`	Hypertension; Aortic Valve Stenosis		EEA national	2	authorised	—	—	4	2	likely eligible pending review
Etofylline `ETOFYLLINE`	—		EEA national	2	authorised	—	—	1	0	likely eligible pending review
Felbinac `FELBINAC`	Myalgia; Arthralgia		EEA national	2	authorised	—	—	1	6	likely eligible pending review
Fenipentol `FENIPENTOL`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Flubendazole `FLUBENDAZOLE`	—		EEA national	2	authorised	—	—	2	1	likely eligible pending review
Fluindione `FLUINDIONE`	Thrombosis		EEA national	2	authorised	—	—	3	14	likely eligible pending review
Gaxilose `GAXILOSE`	—		EEA national	2	authorised	—	—	1	1	likely eligible pending review
Indoramin `INDORAMIN`	Hypertension		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Iprazochrome `IPRAZOCHROME`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Lofepramine `LOFEPRAMINE`	Depressive Disorder		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Lutetium Lu-177 Zadavotide Guraxetan `LUTETIUM 177LU ZADAVOTIDE GURAXETAN`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Metergoline `METERGOLINE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Mexazolam `MEXAZOLAM`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Morniflumate `MORNIFLUMATE`	—		EEA national	2	authorised	—	—	4	0	likely eligible pending review
Penfluridol `PENFLURIDOL`	—		EEA national	2	authorised	—	—	4	1	likely eligible pending review
Pheneticillin `PHENETICILLIN`	—		EEA national	2	authorised	—	—	0	2	likely eligible pending review
Pholcodine `PHOLCODINE`	Cough		EEA national	2	authorised	—	—	2	2	likely eligible pending review
Piketoprofen `PIKETOPROFEN`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Pirenoxine `PIRENOXINE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Prenoxdiazine `PRENOXDIAZIN`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Protionamide `PROTIONAMIDE`	Tuberculosis		EEA national	2	authorised	rare disease	—	2	15	likely eligible pending review
Pyritinol `PYRITINOL`	Attention Deficit Disorder with Hyperactivity		EEA national	2	authorised	—	—	0	1	likely eligible pending review
Quifenadine `QUIFENADINE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Sodium Picofosfate `SODIUM PICOFOSFATE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Spaglumic Acid `SPAGLUMIC`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Tribenoside `TRIBENOSIDE`	—		EEA national	2	authorised	—	—	2	2	likely eligible pending review
Trimecaine `TRIMECAINE`	—		EEA national	2	authorised	—	—	1	1	likely eligible pending review
Valpromide `VALPROMIDE`	—		EEA national	2	authorised	—	—	9	1	likely eligible pending review
Vinburnine `VINBURNINE`	—		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Xipamide `XIPAMIDE`	Cardiovascular Diseases		EEA national	2	authorised	—	—	0	0	likely eligible pending review
Zotepine `ZOTEPINE`	Psychotic Disorders		EEA national	2	authorised	—	—	0	3	likely eligible pending review
Alfatradiol `ALFATRADIOL`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Almagate `ALMAGATE`	—		EEA national	1	authorised	—	—	1	0	likely eligible pending review
Almasilate `ALMASILATE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Amitriptylinoxide `AMITRIPTYLINOXIDE`	—		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Androstanolone `ANDROSTANOLONE`	—		EEA national	1	authorised	—	—	1	0	likely eligible pending review
Aniracetam `ANIRACETAM`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Anthralin `DITHRANOL`	—		EEA national	1	authorised	—	—	4	6	likely eligible pending review
Arlipoic Acid `LIPOIC`	—		EEA national	1	authorised	—	—	42	241	likely eligible pending review
Benproperine `BENPROPERINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Bromopride `BROMOPRIDE`	Dyspepsia; Digestive System Diseases		EEA national	1	authorised	—	—	1	1	likely eligible pending review
Bronopol `BRONOPOL`	—		EEA national	1	authorised	—	—	2	4	likely eligible pending review
Carbaldrate `CARBALDRATE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Carbazochrome `CARBAZOCHROME`	—		EEA national	1	authorised	—	—	1	1	likely eligible pending review
Caroverine `CAROVERINE`	—		EEA national	1	authorised	—	—	0	3	likely eligible pending review
Cefatrizine `CEFATRIZINE`	—		EEA national	1	authorised	—	—	6	2	likely eligible pending review
Chlorobutanol `CHLOROBUTANOL`	Nausea		EEA national	1	authorised	—	—	2	7	likely eligible pending review
Chlorocresol `CHLOROCRESOL`	—		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Cicletanine `CICLETANINE`	—		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Cifenline `CIBENZOLINE`	—		EEA national	1	authorised	—	—	3	3	likely eligible pending review
Clofoctol `CLOFOCTOL`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Clonixin `CLONIXIN`	—		EEA national	1	authorised	—	—	0	1	likely eligible pending review
Cloprednol `CLOPREDNOL`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Cloxazolam `CLOXAZOLAM`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Cortivazol `CORTIVAZOL`	—		EEA national	1	authorised	—	—	2	4	likely eligible pending review
Delorazepam `DELORAZEPAM`	—		EEA national	1	authorised	—	—	2	1	likely eligible pending review
Demoxytocin `DEMOXYTOCIN`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Denotivir `DENOTIVIR`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Dimethisoquin `QUINISOCAINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Doxofylline `DOXOFYLLINE`	Lung Diseases, Obstructive; Asthma		EEA national	1	authorised	—	—	4	7	likely eligible pending review
Eberconazole `EBERCONAZOLE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Etizolam `ETIZOLAM`	—		EEA national	1	authorised	—	—	1	1	likely eligible pending review
Flufenamic Acid `FLUFENAMIC`	—		EEA national	1	authorised	—	—	3	2	likely eligible pending review
Fosfructose `FRUCTOSE 1 6`	—		EEA national	1	authorised	—	—	35	39	likely eligible pending review
Fotemustine `FOTEMUSTINE`	Neoplasms; Melanoma; Uveal Melanoma		EEA national	1	authorised	—	—	4	14	likely eligible pending review
Framycetin `FRAMYCETIN`	Nasal Obstruction; Eye Infections		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Fumagillin `FUMAGILLIN`	—		EEA national	1	authorised	EU orphan designation	—	4	0	likely eligible pending review
Gabexate `GABEXATE`	Liver Diseases		EEA national	1	authorised	—	—	2	9	likely eligible pending review
Glutaral `GLUTARAL`	—		EEA national	1	authorised	—	—	0	41	likely eligible pending review
Heptaminol `HEPTAMINOL`	—		EEA national	1	authorised	—	—	0	1	likely eligible pending review
Ibopamine `IBOPAMINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Iproniazid `IPRONIAZID`	Depressive Disorder		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Isothipendyl `ISOTHIPENDYL`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Josamycin `JOSAMYCIN`	Premature Birth; Bacterial Infections		EEA national	1	authorised	—	—	26	1	likely eligible pending review
Lidofenin `LIDOFENIN`	—		EEA national	1	authorised	—	—	0	1	likely eligible pending review
Medrogestone `MEDROGESTONE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Melarsoprol `MELARSOPROL`	Trypanosomiasis; Leishmaniasis		EEA national	1	authorised	EU orphan designation	—	3	1	likely eligible pending review
Mephenoxalone `MEPHENOXALONE`	—		EEA national	1	authorised	—	—	0	18	likely eligible pending review
Merbromin `MERBROMIN`	—		EEA national	1	authorised	—	—	0	1	likely eligible pending review
Methylcobalamin `METHYLCOBALAMIN`	—		EEA national	1	authorised	—	—	17	627	likely eligible pending review
Metopimazine `METOPIMAZINE`	—		EEA national	1	authorised	—	—	4	2	likely eligible pending review
Moxisylyte `MOXISYLYTE`	Cardiovascular Diseases; Erectile Dysfunction		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Neridronic Acid `NERIDRONATE`	—		EEA national	1	authorised	—	—	13	7	likely eligible pending review
Nikethamide `NIKETHAMIDE`	Respiratory Tract Diseases		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Nimorazole `NIMORAZOLE`	Amebiasis		EEA national	1	authorised	EU orphan designation	—	0	10	likely eligible pending review
Nonivamide `NONIVAMIDE`	Low Back Pain		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Nordazepam `NORDAZEPAM`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Norethandrolone `NORETHANDROLONE`	Leukemia, Myeloid, Acute		EEA national	1	authorised	—	—	2	1	likely eligible pending review
Oxatomide `OXATOMIDE`	Hypersensitivity		EEA national	1	authorised	—	—	10	1	likely eligible pending review
Phenibut `4 AMINO 3 PHENYLBUTYRIC`	—		EEA national	1	authorised	—	—	0	2	likely eligible pending review
Phenolphthalein `PHENOLPHTHALEIN`	Constipation		EEA national	1	authorised	—	—	4	3	likely eligible pending review
Phenothrin `PHENOTHRIN`	Ectoparasitic Infestations		EEA national	1	authorised	—	—	2	0	likely eligible pending review
Picloxydine `PICLOXYDINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Pidotimod `PIDOTIMOD`	—		EEA national	1	authorised	—	—	18	1	likely eligible pending review
Pinazepam `PINAZEPAM`	—		EEA national	1	authorised	—	—	0	1	likely eligible pending review
Pipemidic Acid `PIPEMIDIC`	—		EEA national	1	authorised	—	—	3	0	likely eligible pending review
Pipotiazine `PIPOTIAZINE`	—		EEA national	1	authorised	—	—	0	3	likely eligible pending review
Pirenzepine `PIRENZEPINE`	Peptic Ulcer; Gastroesophageal Reflux		EEA national	1	authorised	—	—	7	4	likely eligible pending review
Piretanide `PIRETANIDE`	Cardiovascular Diseases		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Pirlindole `PIRLINDOLE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Piroxicam Cinnamate `PIROXICAM CINNAMATE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Pranoprofen `PRANOPROFEN`	—		EEA national	1	authorised	—	—	1	8	likely eligible pending review
Proflavine `PROFLAVINE`	—		EEA national	1	authorised	—	—	0	22	likely eligible pending review
Reproterol `REPROTEROL`	Lung Diseases, Obstructive		EEA national	1	authorised	—	—	1	1	likely eligible pending review
Rociverine `ROCIVERINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Rufloxacin `RUFLOXACIN`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Rutin `RUTOSIDE`	—		EEA national	1	authorised	—	—	3	55	likely eligible pending review
Sodium Aurotiosulfate `SODIUM AUROTIOSULFATE`	—		EEA national	1	authorised	—	—	0	3	likely eligible pending review
Sulisobenzone `SULISOBENZONE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Temgicoluril `TEMGICOLURIL`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Thiram `THIRAM`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Trepibutone `TREPIBUTONE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Trimeperidine `TRIMEPERIDINE`	—		EEA national	1	authorised	—	—	1	3	likely eligible pending review
Trofosfamide `TROFOSFAMIDE`	Sarcoma; Neoplasms		EEA national	1	authorised	—	—	11	4	likely eligible pending review
Tromantadine `TROMANTADINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Tropatepine `TROPATEPINE`	—		EEA national	1	authorised	—	—	0	0	likely eligible pending review
Vincamine `VINCAMINE`	Cardiovascular Diseases		EEA national	1	authorised	—	—	2	0	likely eligible pending review
Xibornol `XIBORNOL`	—		EEA national	1	authorised	—	—	1	0	likely eligible pending review
Ataluren `ATALUREN`	Duchenne muscular dystrophy	Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. Efficacy has not been demonstrated in non-ambulatory patients. The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.	EMA	0	previously_authorised	rare disease, pediatric onset, EU orphan designation, licence pulled	M09AX03	34	34	likely eligible pending review
Aumolertinib `AUMOLERTINIB`	Carcinoma, Non-Small-Cell Lung	Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (forbiomarker-based patient selection, see section 4.2).- the treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC (forbiomarker-based patient selection, see section 4.2)	EMA	0	previously_authorised	licence pulled	L01EB	0	80	likely eligible pending review
Lasofoxifene `LASOFOXIFENE`	Osteoporosis, Postmenopausal	Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1). When determining the choice of Fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).	EMA	0	previously_authorised	licence pulled	G03	0	9	likely eligible pending review
Leriglitazone `LERIGLITAZONE`	Adrenoleukodystrophy	Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1.	EMA	0	authorised	orphan, EU orphan designation	A16AX23	2	2	likely eligible pending review
Methylparaben `E 218`	—		Swissmedic	0	authorised	—	—	0	0	likely eligible pending review
Perflenapent `DODECAFLUOROPENTANE`	Echocardiography	EchoGen is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular border delineation with resulting improvement in wall motion visualisation. EchoGen should only be used in patients where the study without contrast enhancement is inconclusive.	EMA	0	previously_authorised	licence pulled	V08DA	0	6	likely eligible pending review
Pixantrone `PIXANTRONE`	Non-Hodgkin lymphoma	Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.	EMA	0	previously_authorised	rare disease, licence pulled	L01DB11	3	18	likely eligible pending review
Rimonabant `RIMONABANT`	Obesity	As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).	EMA	0	previously_authorised	licence pulled	A08AX01	10	48	likely eligible pending review
Sitaxentan `SITAXENTAN`	Hypertension, Pulmonary	Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.	EMA	0	previously_authorised	licence pulled	C02KX03	10	24	likely eligible pending review
Temoporfin `TEMOPORFIN`	Head and Neck Neoplasms;Carcinoma, Squamous Cell	Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.	EMA	0	authorised	—	L01XD05	0	8	likely eligible pending review