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法规知识库 · EMA 集中审评

ImmunoGam

human hepatitis B immunoglobulin · EMEA/H/C/001055 · 已撤市

获批上市许可

2010-03-16

欧委会决定日

2010-09-06

持有人 / 申请人

Cangene Europe Limited

终止日期字段

2010-09-06

从产品到官方文件

文件记录

4

官方索引 4

EPAR / 审评

2

assessment / overview 等

产品信息

2

PI / presentations

其他

0

RMP / PIP 等

ATC:J06BB04

治疗领域:Immunization, Passive;Hepatitis B

药理分类:Specific immunoglobulins

修订号:— · 最新影响 PI 的程序:—

适应症(原文):Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.

关键日期时间轴

来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。

  1. 2010-09-06 · 欧委会决定

  2. 2010-09-06 · 上市许可终止(撤市/失效/撤销等)

    Withdrawn

  3. 2010-03-16 · 获批上市许可

说明书、EPAR 与其他文件

仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。

EPAR / 审评资料 2产品信息 2其他 0

EPAR / 审评资料

产品信息

数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。