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治疗领域： 活性成分： 药物剂型：
合规检查： 给物途径： 决定日期：-格式:2020-5-3
 欧盟EMA儿科检查计划（PIP）的意见和决定2122条(本栏目收费,不能显示细节,电话13136136841)
活性物质
治疗领域
决定日期
合规检查
状态
药物剂型
给物途径
合规意见日期
Avacopan
Immunology-Rheumatology-Transplantation
2020/3/20 1:00:00
no
Treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
Capsule, hard, Age-appropriate oral solid dosage form, Age-appropriate oral liquid dosage form
Oral use
1970/1/1 2:00:00
Vadadustat
Haematology-Hemostaseology
2020/3/21 1:00:00
no
Treatment of anaemia due to chronic disorders
Tablet, Age-appropriate oral formulation
Oral use
1970/1/1 2:00:00
Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897)
Infectious diseases
2020/3/18 1:00:00
no
Prevention of lower respiratory tract disease caused by respiratory syncytial virus
Solution for injection
Intramuscular use
1970/1/1 2:00:00
Burosumab
Other
2020/3/18 1:00:00
no
Treatment of X-linked hypophosphataemia
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
bezlotoxumab
Infectious diseases
2020/3/20 1:00:00
no
Prevention of recurrence of Clostridioides difficile infection
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
eluxadoline
Gastroentology-Hepatology
2020/3/18 1:00:00
no
Treatment of diarrhoea-predominant irritable bowel Syndrome
Film-coated tablet, Age-appropriate oral liquid dosage form
Oral use
1970/1/1 2:00:00
sodium zirconium cyclosilicate
Endocrinology, -gynacology-fertility-metabolism
2020/3/18 1:00:00
no
Treatment of hyperkalaemia
Oral powder
Oral use, Nasogastric use
1970/1/1 2:00:00
Idasanutlin
Oncology
2020/3/18 1:00:00
no
Treatment of acute lymphoblastic leukaemia, Treatment of acute myeloid leukaemia
Film-coated tablet, Film-coated dispersible tablet
Oral use
1970/1/1 2:00:00
Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Neurology, Ophthalmology
2020/3/30 0:00:00
no
Treatment of sialorrhoea
Solution for injection
Intraglandular use, Intramuscular use
1970/1/1 2:00:00
eftrenonacog alfa
Haematology-Hemostaseology
2020/3/18 1:00:00
no
Treatment of hereditary factor-IX deficiency
Powder and solvent for solution for injection
Intravenous use
1970/1/1 2:00:00
sonidegib
Oncology
2020/3/20 1:00:00
no
Treatment of medulloblastoma
Capsule, hard, Film-coated tablet, Powder and solvent for oral suspension
Oral use
1970/1/1 2:00:00
ixekizumab
Dermatology
2020/3/18 1:00:00
no
Treatment of psoriasis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Eculizumab
Neurology
2020/3/21 1:00:00
no
Treatment of neuromyelitis optica spectrum disorders
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Pegcetacoplan
Haematology-Hemostaseology
2020/4/17 0:00:00
no
Treatment of paroxysmal nocturnal haemoglobinuria
Solution for infusion
Subcutaneous use
1970/1/1 2:00:00
dapagliflozin
Endocrinology, -gynacology-fertility-metabolism
2020/3/18 1:00:00
no
Treatment of type II diabetes mellitus
Film-coated tablet
Oral use
1970/1/1 2:00:00
tenofovir disoproxil fumarate
Infectious diseases
2020/3/20 1:00:00
no
Treatment of chronic viral hepatitis B, Treatment of human immunodeficiency virus (HIV-1) disease resulting in other conditions
Film-coated tablet, Granules
Oral use
1970/1/1 2:00:00
alogliptin
Endocrinology, -gynacology-fertility-metabolism
2020/3/18 1:00:00
no
Treatment of type II diabetes mellitus
Film-coated tablet
Oral use
1970/1/1 2:00:00
posaconazole
Infectious diseases
2020/3/18 1:00:00
no
Prevention of invasive fungal infections, Treatment of invasive fungal infections
Oral suspension, Gastro-resistant tablet, Gastro-resistant powder for oral suspension, Concentrate for solution for infusion
Oral use, Intravenous use
1970/1/1 2:00:00
perampanel
Neurology
2020/3/18 1:00:00
no
Treatment of treatment-resistant epilepsies
Tablet, Oral suspension
Oral use
1970/1/1 2:00:00
denosumab
Endocrinology, -gynacology-fertility-metabolism
2020/3/20 1:00:00
no
Treatment of osteoporosis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
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