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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
Verdiperstat
Neurology
2020/3/18 1:00:00
no
Treatment of multiple system atrophy
Coated tablet
Oral use
1970/1/1 2:00:00
Eftilagimod alpha
Oncology
2020/3/27 1:00:00
no
Treatment of breast cancer
Solution for injection
Subcutaneous use, Intravenous use, Intratumoral use, Intraperitoneal use
1970/1/1 2:00:00
Parsaclisib
Oncology
2020/3/18 1:00:00
no
Treatment of mature B-cell malignancies
Tablet
Oral use
1970/1/1 2:00:00
Zolbetuximab
Oncology
2020/3/18 1:00:00
no
Treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma, Treatment of pancreatic cancer
Powder for solution for injection
Intravenous use
1970/1/1 2:00:00
Brolucizumab
Ophthalmology
2020/3/20 1:00:00
no
Treatment of visual impairment due to macular edema associated with retinal vein occlusion (branch RVO or central RVO)
Solution for injection
Intravitreal use
1970/1/1 2:00:00
6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one
Oncology
2020/3/18 1:00:00
no
Treatment of lung cancer
Film-coated tablet
Oral use
1970/1/1 2:00:00
levodopa, carbidopa
Neurology
2020/3/18 1:00:00
no
Treatment of Parkinson's disease
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
( 2S )-2-[ [ 2-[ ( 4S)-4-( difluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo [ 1,2- d] [ 1,4 ]benzoxazepin-9-yl]amino ]propanamide
Oncology
2020/3/18 1:00:00
no
Treatment of breast cancer
Tablet, Powder for oral solution
Oral use
1970/1/1 2:00:00
5%-Δ9-tetrahydrocannabinol standardised Cannabis extract
Pain
2020/3/18 1:00:00
no
Treatment of chronic pain
Oral solution
Oral use
1970/1/1 2:00:00
Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB)
Oncology
2020/3/18 1:00:00
no
Treatment of mature B-cell neoplasms
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Levothyroxine (sodium)
Endocrinology, -gynacology-fertility-metabolism
2018/3/16 1:00:00
no
Treatment of benign thyroid nodules, Treatment of goitre, Treatment of hypothyroidism
Oral solution
Oral use
1970/1/1 2:00:00
Zoliflodacin
Infectious diseases
2020/3/21 1:00:00
no
Treatment of gonococcal infection
Granules for oral suspension
Oral use
1970/1/1 2:00:00
Efgartigimod alfa
Neurology
2020/3/18 1:00:00
no
Treatment of myasthenia gravis
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Autologous CD34+enriched cells from patients with Fanconi anaemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene (PGK-FANCA-WPRE)
Haematology-Hemostaseology
2020/3/18 1:00:00
no
Treatment of Fanconi anaemia subtype A
Dispersion for infusion
Intravenous use
1970/1/1 2:00:00
Soticlestat
Neurology
2020/3/18 1:00:00
no
Treatment of Chromosome 15q Duplication Syndrome, Treatment of Cyclin-Dependent Kinase-Like 5 deficiency disorder
Film-coated tablet, Age-appropriate oral formulation
Oral use, Gastric use
1970/1/1 2:00:00
cenobamate
Neurology
2020/3/18 1:00:00
no
Treatment of epilepsy
Tablet, Film-coated tablet, Age-appropriate oral liquid dosage form, Age-appropriate dosage form for parenteral use
Oral use, Parenteral use, Gastric use
1970/1/1 2:00:00
Anti-neonatal Fc receptor human monoclonal antibody
Other
2020/3/18 1:00:00
no
Treatment of myasthenia gravis
Solution for infusion, Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding for the human Beta 2 Integrin/CD18 gene
Immunology-Rheumatology-Transplantation
2020/3/20 1:00:00
no
Treatment of leukocyte adhesion deficiency type I
Dispersion for infusion
Intravenous use
1970/1/1 2:00:00
Tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82)
Gastroentology-Hepatology
2020/3/18 1:00:00
no
Treatment of non-alcoholic steatohepatitis (NASH)
Tablet
Oral use
1970/1/1 2:00:00
1-[ 4-bromo-5-[ 1-ethyl-7-( methylamino )-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl ]-2-fluorophenyl]-3-
Oncology
2020/3/18 1:00:00
no
Treatment of gastrointestinal stromal tumours
Tablet
Oral use
1970/1/1 2:00:00
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