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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
Ibrexafungerp
Infectious diseases
2020/4/17 0:00:00
no
Prevention of recurrent vulvovaginal candidiasis, Treatment of vulvovaginal candidiasis
Tablet
Oral use
1970/1/1 2:00:00
glycerol, urea
Dermatology
2020/4/15 0:00:00
no
Treatment of dry skin
Cream
Cutaneous use
1970/1/1 2:00:00
Dihomo-y-linolenic acid
Dermatology
2020/4/15 0:00:00
no
Treatment of atopic dermatitis
Age-appropriate oral liquid dosage form, Capsule, soft
Oral use
1970/1/1 2:00:00
2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile
Pneumology-allergology
2020/4/18 0:00:00
no
Treatment of interstitial pulmonary diseases with fibrosis
Film-coated tablet, Age-appropriate formulation
Oral use
1970/1/1 2:00:00
(S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(4-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride (daridorexant)
Psychiatry
2020/4/15 0:00:00
no
Treatment of insomnia
Age-appropriate oral solid dosage form, Film-coated tablet
Oral use
1970/1/1 2:00:00
leriglitazone
Neurology
2020/4/18 0:00:00
no
Treatment of adrenoleukodystrophy
Oral suspension
Oral use
1970/1/1 2:00:00
lenadogene nolparvovec
Neurology
2020/4/24 0:00:00
no
Treatment of Leber Hereditary Optic Neuropathy
Solution for injection
Intravitreal use
1970/1/1 2:00:00
lanadelumab
Other
2020/4/18 0:00:00
no
Prevention of acquired angioedema attacks
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Propan-2-yl 2-[5-( acryloylamino )-4-{ [2-( dimethylamino )ethyl] ( methyl)amino }-2-methoxyanilino ]-4- ( 1 methyl-1 H-indol-3-yl)pyrimidine-5-carboxylate
Oncology
2020/4/16 0:00:00
no
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
Capsule, hard
Oral use
1970/1/1 2:00:00
lazertinib (mesilate)
Oncology
2020/4/15 0:00:00
no
Treatment of lung carcinoma (small cell and non-small cell carcinoma)
Film-coated tablet
Oral use
1970/1/1 2:00:00
alpha1-proteinase inhibitor (human)
Immunology-Rheumatology-Transplantation
2020/4/15 0:00:00
no
Prevention of graft versus host disease
Powder and solvent for solution for injection, Powder and solvent for solution for infusion
Intravenous use
1970/1/1 2:00:00
belantamab mafodotin
Oncology
2020/9/11 0:00:00
no
Treatment of Multiple Myeloma
Powder for concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
dolutegravir, abacavir, lamivudine
Infectious diseases
2019/1/3 1:00:00
no
Treatment of human immunodeficiency virus (HIV-1) infection
Film-coated tablet, Dispersible tablet
Oral use
1970/1/1 2:00:00
Mepolizumab
Pneumology-allergology
2018/9/12 0:00:00
no
Treatment of vasculitides
Powder for solution for injection or infusion, Solution for injection
Subcutaneous use
1970/1/1 2:00:00
ambrisentan
Cardiovascular diseases
2017/1/30 1:00:00
no
Treatment of pulmonary arterial hypertension
Film-coated tablet
Oral use
1970/1/1 2:00:00
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Pneumology-allergology
2020/2/14 1:00:00
no
Treatment of asthma
Inhalation powder, pre-dispensed
Inhalation use
1970/1/1 2:00:00
Albiglutide
Endocrinology, -gynacology-fertility-metabolism
2016/10/7 0:00:00
no
Treatment of type II diabetes mellitus
Powder and solvent for solution for injection
Subcutaneous use
1970/1/1 2:00:00
belimumab
Immunology-Rheumatology-Transplantation
2020/1/6 1:00:00
no
Treatment of Systemic Lupus Erythematosus (SLE)
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
dolutegravir
Infectious diseases
2019/1/3 1:00:00
no
Treatment of human immunodeficiency virus (HIV-1) infection
Coated tablet, Age-appropriate oral solid dosage form
Oral use
1970/1/1 2:00:00
Mepolizumab
Pneumology-allergology
2017/8/11 0:00:00
yes
Treatment of asthma
Powder for solution for injection / infusion, Solution for injection
Intravenous use, Subcutaneous use
2017/11/10 2:00:00
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