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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
Setmelanotide
Nutrition
2020/5/15 0:00:00
no
Treatment of appetite and general nutrition disorders
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
Infectious diseases, Vaccines
2020/5/20 0:00:00
no
Prevention of lower respiratory tract disease caused by respiratory syncytial virus
Solution for injection
Intramuscular use
1970/1/1 2:00:00
Gilteritinib (as fumarate)
Haematology-Hemostaseology
2020/5/13 0:00:00
no
Treatment of acute myeloid leukaemia
Film-coated tablet, Age-appropriate oral dosage form
Oral use
1970/1/1 2:00:00
Alicaforsen
Gastroentology-Hepatology
2020/5/15 0:00:00
no
Treatment of pouchitis
Rectal solution
Rectal use
1970/1/1 2:00:00
Avalglucosidase alfa
Endocrinology, -gynacology-fertility-metabolism
2020/5/13 0:00:00
no
Treatment of Pompe disease
Powder for concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Volanesorsen
Endocrinology, -gynacology-fertility-metabolism
2020/5/13 0:00:00
no
Treatment of familial chylomicronemia syndrome
Solution for injection
Intravenous use
1970/1/1 2:00:00
Lenvatinib
Oncology
2020/6/16 0:00:00
no
Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thyroid cancer, follicular thyroid cancer and osteosarcoma
Capsule, hard
Oral use
1970/1/1 2:00:00
rolapitant
Haematology-Hemostaseology
2020/5/15 0:00:00
no
Prevention of nausea and vomiting
Film-coated tablet, Age-appropriate oral dosage form
Oral use
1970/1/1 2:00:00
Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Vaccines
2020/5/15 0:00:00
no
Prevention of influenza infection
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Chloroprocaine hydrochloride
Anaesthesiology
2020/6/17 0:00:00
no
Ocular surface anaesthesia
Eye gel
Ocular use
1970/1/1 2:00:00
tezacaftor, ivacaftor
Pneumology-allergology
2020/5/15 0:00:00
no
Treatment of cystic fibrosis
Film-coated tablet, Age-appropriate oral formulation
Oral use
1970/1/1 2:00:00
Bilastine
Dermatology, Oto-rhino-laryngology, Pneumology-allergology
2020/6/17 0:00:00
no
Treatment of acute type I hypersensitivity reactions
Oral solution, Orodispersible tablet, Solution for injection, Tablet
Oral use, Intramuscular use, Intravenous use
1970/1/1 2:00:00
afatinib
Oncology
2020/5/13 0:00:00
no
Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, haematopoietic and lymphoid tissue neoplasms), Treatment of malignant neoplasms of the central nervous system
Oral use
Film-coated tablet, Capsules and solvent for oral solution
1970/1/1 2:00:00
Polymyxin B
Infectious diseases
2020/4/17 0:00:00
no
Treatment of infections due to aerobic Gram-negative bacteria
Powder for solution for injection
Intravenous use
1970/1/1 2:00:00
Bintrafusp alfa
Oncology
2020/4/18 0:00:00
no
Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
Concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
N-(3-{6-Amino-5-[2-(N-methylprop-2-enamido)ethoxy]pyrimidin-4-yl}-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide
Dermatology
2020/4/17 0:00:00
no
Treatment of chronic spontaneous urticaria
Age-appropriate oral solid dosage form, Coated tablet
Oral use
1970/1/1 2:00:00
Pracinostat
Oncology
2020/4/3 0:00:00
no
Treatment of acute myeloid leukaemia
Capsule, hard, Granules for oral suspension
Oral use, Gastric use
1970/1/1 2:00:00
elbasvir
Infectious diseases
2015/12/21 1:00:00
no
Treatment of chronic hepatitis C
Film-coated tablet, Granules
Oral use
1970/1/1 2:00:00
Lebrikizumab
Dermatology
2020/4/17 0:00:00
no
Treatment of atopic dermatitis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
grazoprevir
Infectious diseases
2015/12/21 1:00:00
no
Treatment of chronic hepatitis C
Film-coated tablet, Granules
Oral use
1970/1/1 2:00:00
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