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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
ribociclib succinate
Oncology
2020/6/17 0:00:00
no
Treatment of breast cancer
Film-coated tablet
Oral use
1970/1/1 2:00:00
rucaparib camsylate
Oncology
2020/6/22 0:00:00
no
Treatment of fallopian tube cancer, Treatment of ovarian cancer, Treatment of primary peritoneal cancer, Treatment of prostate malignant neoplasms
Film-coated tablet
Oral use
1970/1/1 2:00:00
Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV]
Infectious diseases
2020/4/17 0:00:00
no
Prevention of Ebola virus disease
Suspension for injection
Intramuscular use
1970/1/1 2:00:00
Mirikizumab
Dermatology
2020/4/15 0:00:00
no
Treatment of psoriasis, Treatment of ulcerative colitis
Concentrate for solution for infusion, Solution for injection
Intravenous use, Subcutaneous use
1970/1/1 2:00:00
Crisaborole
Dermatology
2021/4/16 0:00:00
no
Treatment of atopic dermatitis
Ointment
Topical use
1970/1/1 2:00:00
axicabtagene ciloleucel
Oncology
2020/4/15 0:00:00
no
Treatment of mature B-cell neoplasms
Dispersion for infusion
Intravenous use
1970/1/1 2:00:00
IMG-2789
Haematology-Hemostaseology
2020/6/16 0:00:00
no
Treatment of myeloproliferative neoplasms
Capsule, hard
Oral use
1970/1/1 2:00:00
Adeno-associated virus serotype 2 encoding human aromatic L-amino acid decarboxylase
Neurology
2020/6/16 0:00:00
no
Treatment of Parkinson's disease
Solution for infusion
Intracerebral use
1970/1/1 2:00:00
Monalizumab
Oncology
2020/6/16 0:00:00
no
Treatment of head and neck epithelial malignant neoplasms
Powder for concentrate for solution for infusion
Intravenous use
1970/1/1 2:00:00
Adenovirus encoding vascular endothelial growth factor C
Other
2020/6/19 0:00:00
no
Secondary lymphedema associated with the treatment of breast cancer
Solution for injection
Ex vivo intranodal injection
1970/1/1 2:00:00
Macimorelin
Endocrinology, -gynacology-fertility-metabolism
2020/4/6 0:00:00
no
Diagnosis of growth hormone deficiency
Granules for oral solution
Oral use
1970/1/1 2:00:00
Rozanolixizumab
Neurology
2020/6/19 0:00:00
no
Treatment of myasthenia gravis
Solution for infusion
Subcutaneous use
1970/1/1 2:00:00
Tralokinumab
Dermatology
2020/4/15 0:00:00
no
Treatment of atopic dermatitis
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Autologous haptenised and irradiated cell lysates derived from glioma
Oncology
2020/6/17 0:00:00
no
Treatment of glioma
Solution for injection
Intradermal use
1970/1/1 2:00:00
Allogeneic haptenised and irradiated cell lysates derived from glioma
Oncology
2020/6/17 0:00:00
no
Treatment of glioma
Solution for injection
Intradermal use
1970/1/1 2:00:00
Allogeneic haptenised and irradiated cells derived from glioma
Oncology
2020/6/17 0:00:00
no
Treatment of glioma
Solution for injection
Intradermal use
1970/1/1 2:00:00
Autologous haptenised and irradiated cells derived from glioma
Oncology
2020/6/17 0:00:00
no
Treatment of glioma
Solution for injection
Intradermal use
1970/1/1 2:00:00
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Oncology
2020/4/18 0:00:00
no
Treatment of acute lymphoblastic leukaemia
Dispersion for injection
Intravenous use
1970/1/1 2:00:00
Galcanezumab
Neurology
2020/4/15 0:00:00
no
Prevention of migraine headaches
Solution for injection
Subcutaneous use
1970/1/1 2:00:00
Elafibranor
Gastroentology-Hepatology
2020/4/17 0:00:00
no
Treatment of non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH)
Capsule, hard, Coated tablet
Oral use
1970/1/1 2:00:00
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