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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
Betula pendula, Corylus avellana, Alnus glutinosa
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
highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
Vaccines
2020/11/27 1:00:00
no
Prevention of Coronavirus disease 2019 (COVID-19)
Concentrate for solution for injection
Intramuscular use
1970/1/1 2:00:00
mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273)
Vaccines
2020/11/30 1:00:00
no
Prevention of Coronavirus disease 2019 (COVID-19)
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
Vaccines
2009/4/24 0:00:00
no
Influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine
Emulsion and suspension for emulsion for injection
Intramuscular injection
1970/1/1 2:00:00
Molidustat (sodium)
Haematology-Hemostaseology
2014/10/27 1:00:00
no
Treatment of anaemia due to chronic disorders
Film-coated tablet, Oral liquid
Oral use
1970/1/1 2:00:00
fremanezumab
Neurology
2017/12/19 1:00:00
no
Prevention of cluster headaches
Solution for injection
Intravenous use, Subcutaneous use
1970/1/1 2:00:00
tilmanocept
Diagnostic
2018/4/11 0:00:00
no
Visualisation of lymphatic drainage of solid malignant tumours for diagnostic purposes
Kit for radiopharmaceutical preparation
Intradermal use, Subcutaneous use, Intratumoral use, Peritumoural use, Intralymphatic use, Interstitial use
1970/1/1 2:00:00
meropenem trihydrate
Infectious diseases
2015/10/22 0:00:00
no
Treatment of Gram-negative bacterial infections
Powder for solution for infusion
Intravenous use
1970/1/1 2:00:00
N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
Pneumology-allergology
2019/5/17 0:00:00
no
Treatment of cystic fibrosis
Oral use
Capsule, hard, Age-appropriate oral dosage form
1970/1/1 2:00:00
canagliflozin
Endocrinology, -gynacology-fertility-metabolism
2017/8/9 0:00:00
no
Treatment of type II diabetes mellitus
Tablet
Oral use
1970/1/1 2:00:00
Anti-mucosal addressin cell adhesion molecule antibody (SHP647)
Gastroentology-Hepatology
2018/9/12 0:00:00
no
Treatment of Crohn's disease, Treatment of ulcerative colitis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Fevipiprant
Pneumology-allergology
2019/9/10 0:00:00
no
Treatment of asthma
Tablet, Chewable tablet, Age-appropriate oral liquid dosage form
Oral use
1970/1/1 2:00:00
captopril
Cardiovascular diseases
2014/8/8 0:00:00
no
Treatment of heart failure
Age-appropriate oral liquid dosage form
Oral use
1970/1/1 2:00:00
Eladocagene exuparvovec
Neurology
2020/3/18 1:00:00
no
Treatment of aromatic L-amino acid decarboxylase deficiency
Solution for infusion, Concentrate for solution for injection
Intracerebral use, Intracerebroventricular use, Intracisternal use, Intrathecal use
1970/1/1 2:00:00
Evinacumab
Endocrinology, -gynacology-fertility-metabolism
2020/3/18 1:00:00
no
Treatment of elevated cholesterol
Solution for infusion
Intravenous use
1970/1/1 2:00:00
bupivacaine, meloxicam (HTX-011)
Pain
2020/3/18 1:00:00
no
Treatment of acute postoperative pain
Solution for injection
Application to surgical site
1970/1/1 2:00:00
Risdiplam (RO7034067)
Neurology
2020/3/18 1:00:00
no
Treatment of spinal muscular atrophy
Powder for oral solution
Oral use
1970/1/1 2:00:00
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc]
Vaccines
2020/3/18 1:00:00
no
Prevention of influenza
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Emapalumab
Immunology-Rheumatology-Transplantation
2020/3/20 1:00:00
no
Treatment of haemophagocytic lymphohistiocytosis
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Entrectinib
Oncology
2019/1/4 1:00:00
no
Treatment of all conditions induded in the category of malignant neoplasms ( except haematopoietic and lymphoid tissue neoplasms)
Capsule, hard, Coated granules
Oral use, Gastric use
1970/1/1 2:00:00
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