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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
Gepotidacin
Infectious diseases
2020/6/16 0:00:00
no
Treatment of uncomplicated urogenital gonorrhea
Age appropriate oral formulation, Film-coated tablet
Oral use
1970/1/1 2:00:00
Gepotidacin
Infectious diseases
2020/6/16 0:00:00
no
Treatment of uncomplicated urinary tract infections
Age appropriate oral formulation, Film-coated tablet
Oral use
1970/1/1 2:00:00
fidanacogene elaparvovec
Haematology-Hemostaseology
2020/6/17 0:00:00
no
Treatment of congenital factor IX deficiency (haemophilia B)
Solution for infusion
Intravenous use
1970/1/1 2:00:00
Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo]
Infectious diseases
2020/4/17 0:00:00
no
Prevention of Ebola virus disease
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Boceprevir
Infectious diseases
2020/4/17 0:00:00
no
Treatment of chronic hepatitis C
Granules, Capsule, hard
Oral use
1970/1/1 2:00:00
Tofacitinib
Gastroentology-Hepatology
2020/4/24 0:00:00
no
Treatment of ulcerative colitis
Film-coated tablet, Oral solution, Prolonged-release film-coated tablet, Prolonged-release age-appropriate oral formulation
Oral use
1970/1/1 2:00:00
Sodium alginate oligosaccharide
Pneumology-allergology
2020/6/19 0:00:00
no
Treatment of cystic fibrosis
Inhalation powder, Capsule, hard
Inhalation use
1970/1/1 2:00:00
blinatumomab
Oncology
2020/4/18 0:00:00
no
Treatment of acute lymphoblastic leukaemia
Powder for solution for infusion
Intravenous use
1970/1/1 2:00:00
ivacaftor
Other
2020/4/17 0:00:00
no
Treatment of cystic fibrosis
Film-coated tablet, Granules in sachet
Oral use
1970/1/1 2:00:00
Bis-choline tetrathiomolybdate
Endocrinology, -gynacology-fertility-metabolism
2020/6/19 0:00:00
no
Treatment of Wilson Disease
Age-appropriate oral solid dosage form, Coated tablet
Oral use
1970/1/1 2:00:00
4-[4-({4-[({2-[(3S)-2,6-dioxopiperidin-3-yl]-1-oxo-2,3-dihydro-1H-isoindol-4-yl}oxy)methyl]phenyl}methyl)piperazin-1-yl]-3-fluorobenzonitrile
Oncology
2020/4/17 0:00:00
no
Treatment of mature B-cell neoplasms
Capsule, hard
Oral use
1970/1/1 2:00:00
Pneumococcal polysaccharides individually biotinylated and complexed with a carrier protein (recombinant fusion construct of rhizavidin and Streptococcus pneumoniae derived proteins), 24-valent
Vaccines
2020/4/18 0:00:00
no
Prevention of disease caused by Streptococcus pneumoniae
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes
Neurology
2020/6/16 0:00:00
no
Treatment of ataxia telangiectasia
Dispersion for infusion
Intravenous use
1970/1/1 2:00:00
temozolomide
Oncology
2020/4/17 0:00:00
no
Treatment of malignant glioma
Powder for oral suspension
Gastric use, Oral use
1970/1/1 2:00:00
3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5- fluorobenzonitrile
Oncology
2020/4/17 0:00:00
no
Treatment of renal neoplasms
Tablet
Oral use
1970/1/1 2:00:00
isoflurane
Neonatology-Paediactric Intensive care
2020/5/15 0:00:00
no
Sedation of mechanically ventilated patients
Inhalation vapour, liquid
Inhalation use
1970/1/1 2:00:00
Idasanutlin
Oncology
2020/5/15 0:00:00
no
Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
Film-coated tablet, Film-coated dispersible tablet
Oral use
1970/1/1 2:00:00
Arfolitixorin
Oncology
2020/5/13 0:00:00
no
Treatment of colorectal cancer
Powder for solution for injection
Intravenous use
1970/1/1 2:00:00
Livoletide
Endocrinology, -gynacology-fertility-metabolism
2020/5/13 0:00:00
no
Treatment of Prader-Willi syndrome
Concentrate for solution for injection
Subcutaneous use
1970/1/1 2:00:00
Spesolimab
Dermatology
2020/5/15 0:00:00
no
Prevention of generalized pustular psoriasis, Treatment of generalized pustular psoriasis
Solution for infusion, Solution for injection
Intravenous use, Subcutaneous use
1970/1/1 2:00:00
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