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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
Ladarixin
Endocrinology, -gynacology-fertility-metabolism
2020/3/24 1:00:00
no
Treatment of type I diabetes mellitus
Age-appropriate oral liquid dosage form, Capsule, hard
Oral use
1970/1/1 2:00:00
Mosunetuzumab
Oncology
2020/3/20 1:00:00
no
Treatment of mature B-cell neoplasms
Solution for infusion
Intravenous use
1970/1/1 2:00:00
Timrepigene emparvovec
Ophthalmology
2020/3/20 1:00:00
no
Treatment of choroideremia
Suspension for injection
Ophthalmic use
1970/1/1 2:00:00
avapritinib
Haematology-Hemostaseology
2020/3/18 1:00:00
no
Treatment of mastocytosis
Film-coated tablet
Oral use
1970/1/1 2:00:00
Gefapixant (citrate salt)
Endocrinology, -gynacology-fertility-metabolism
2020/3/18 1:00:00
no
Treatment of endometriosis
Film-coated tablet
Oral use
1970/1/1 2:00:00
Rosuvastatin, Ezetimibe
Cardiovascular diseases
2020/3/18 1:00:00
no
Prevention of cardiovascular events
Film-coated tablet
Oral use
1970/1/1 2:00:00
Daratumumab
Oncology
2020/3/18 1:00:00
no
Treatment of systemic light chain amyloidosis
Concentrate for solution for infusion, Solution for injection
Intravenous use, Subcutaneous use
1970/1/1 2:00:00
Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+progenitor cells (CF), Allogeneic, non-expanded, umbilical cord blood-derived, haematopoietic mature myeloid and lymphoid cells (NF)
Immunology-Rheumatology-Transplantation
2020/3/18 1:00:00
no
Treatment in haematopoietic stem cell transplantation
Dispersion for infusion
Intravenous use
1970/1/1 2:00:00
Nemolizumab
Dermatology
2020/3/20 1:00:00
no
Treatment of prurigo nodularis
Powder and solvent for solution for injection
Subcutaneous use
1970/1/1 2:00:00
baricitinib
Immunology-Rheumatology-Transplantation
2020/3/18 1:00:00
no
Treatment of Systemic Lupus Erythematosus (SLE)
Tablet, Age-appropriate oral formulation
Oral use
1970/1/1 2:00:00
avatrombopag maleate
Haematology-Hemostaseology
2020/3/18 1:00:00
no
Treatment of chemotherapy-induced thrombocytopenia
Film-coated tablet, Powder for oral suspension
Oral use
1970/1/1 2:00:00
natalizumab
Neurology
2020/3/18 1:00:00
no
Treatment of multiple sclerosis
Solution for injection in pre-filled syringe
Subcutaneous use
1970/1/1 2:00:00
Golimumab
Immunology-Rheumatology-Transplantation
2018/3/16 1:00:00
no
Treatment of ulcerative colitis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
(RS)-Bacoflen, D-Sorbitol (PXT3003), naltrexone hydrochloride
Neurology
2020/1/29 1:00:00
no
Treatment of Charcot-Marie-Tooth disease Type 1A
Oral solution
Oral use
1970/1/1 2:00:00
Cannabidiol
Neurology
2020/1/29 1:00:00
no
Treatment of seizures associated with Dravet Syndrome (DS), Treatment of seizures associated with infantile spasms (IS), Treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Treatment of seizures associated with Tuberous Sclerosis Complex (TSC)
Oral solution
Oral use
1970/1/1 2:00:00
Vamorolone
Other
2020/1/29 1:00:00
no
Treatment of Duchenne muscular dystrophy
Oral suspension
Oral use
1970/1/1 2:00:00
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), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Vaccines
2020/1/29 1:00:00
no
Prevention of influenza infection
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage)
Infectious diseases
2020/2/20 1:00:00
no
Prevention of influenza infection
Solution for injection
Intramuscular use
1970/1/1 2:00:00
Vosoritide (BMN 111)
Other
2020/2/10 1:00:00
no
Treatment of achondroplasia
Powder for solution for injection
Subcutaneous use
1970/1/1 2:00:00
nivolumab
Oncology
2020/1/9 1:00:00
no
Treatment of malignant neoplasms of lymphoid tissue, Treatment of malignant neoplasms of the central nervous system
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
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