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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
COVID-19 vaccine (Ad26.COV2-S (recombinant))
Infectious diseases
2021/2/5 1:00:00
no
Prevention of Coronavirus disease 2019 (COVID-19)
Suspension for injection in cartridge
Intramuscular use
1970/1/1 2:00:00
baricitinib
Infectious diseases
2021/2/5 1:00:00
no
Treatment of Coronavirus disease 2019
Tablet and powder for oral solution, Oral suspension for use in drinking water
Gastric use, Oral use
1970/1/1 2:00:00
remdesivir
Infectious diseases
2021/2/5 1:00:00
no
Treatment of Coronavirus disease 2019
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
mitapivat
Haematology-Hemostaseology
2020/9/9 0:00:00
no
Treatment of pyruvate kinase deficiency
Age-appropriate oral solid dosage form, Film-coated tablet
Oral use
1970/1/1 2:00:00
birch pollen, alder pollen
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Coated tablet
Sublingual use
1970/1/1 2:00:00
Dermatophagoides pteronyssinus, Dermatophagoides farinae
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Coated tablet
Sublingual use
1970/1/1 2:00:00
Dermatophagoides pteronyssinus, Dermatophagoides farinae
Pneumology-allergology
2011/6/9 0:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Oromucosal drops
Sublingual use
1970/1/1 2:00:00
Dermatophagoides pteronyssinus, Dermatophagoides farinae
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Suspension for injection
Subcutaneous use
1970/1/1 2:00:00
birch pollen, alder pollen
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Oromucosal drops
Sublingual use
1970/1/1 2:00:00
Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Coated tablet
Sublingual use
1970/1/1 2:00:00
Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Pneumology-allergology
2019/3/22 1:00:00
no
Treatment of allergic rhinitis / rhino-conjunctivitis
Oromucosal drops
Sublingual use
1970/1/1 2:00:00
Tominersen
Neurology
2020/7/15 0:00:00
no
Treatment of Huntington's disease
Solution for injection
Intrathecal use
1970/1/1 2:00:00
Inclisiran sodium
Endocrinology, -gynacology-fertility-metabolism
2018/9/12 0:00:00
no
Treatment of elevated cholesterol
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Brazikumab
Gastroentology-Hepatology
2017/12/19 1:00:00
no
Treatment of Crohn's disease, Treatment of ulcerative colitis
Solution for injection, Solution for infusion
Subcutaneous use, Intravenous use
1970/1/1 2:00:00
Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)
Oncology
2014/4/7 0:00:00
no
Treatment of neuroblastoma
Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Intravenous use
1970/1/1 2:00:00
avatrombopag maleate
Haematology-Hemostaseology
2019/11/22 1:00:00
no
Treatment of Idiopathic Thrombocytopenia Purpura (ITP), Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
Film-coated tablet, Powder for oral suspension
Oral use
1970/1/1 2:00:00
COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Vaccines
2021/1/5 1:00:00
no
Prevention of Coronavirus disease 2019 (COVID-19)
Concentrate for solution for injection
Intramuscular use
1970/1/1 2:00:00
Dermatophagoides farinae, Dermatophagoides pteronyssinus
Pneumology-allergology
2015/11/27 1:00:00
no
Treatment of allergic rhinitis, Treatment of rhino-conjuctivitis
Oromucosal solution
Sublingual use
1970/1/1 2:00:00
Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%)
Pneumology-allergology
2015/11/27 1:00:00
no
Treatment of allergic rhinitis, Treatment of rhino-conjuctivitis
Oromucosal solution
Sublingual use
1970/1/1 2:00:00
Betula pendula
Pneumology-allergology
2015/11/27 1:00:00
no
Treatment of allergic rhinitis, Treatment of rhino-conjuctivitis
Oral solution
Oral use
1970/1/1 2:00:00
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