腹寧朗錠10毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

METOCLOPRAMIDE HCL MONOHYDRATE

可用日期:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC代码:

A03FA01

药物剂型:

錠劑

组成:

METOCLOPRAMIDE HCL MONOHYDRATE (5622000715) MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

SANOFI-AVENTIS FRANCE 1-13, BOULEVARD ROMAIN ROLLAND 75014 PARIS, FRANCE FR

治疗领域:

metoclopramide

疗效迹象:

預防嘔吐、逆流性消化性、食道炎、糖尿病引起之胃腸蠕動異常。

產品總結:

註銷日期: 2018/08/21; 註銷理由: 自請註銷; 有效日期: 2021/02/09; 英文品名: Primperan scored tablets 10mg

授权状态:

已註銷

授权日期:

2006-02-09

资料单张

Property of the Sanofi group - strictly confidential
Page 1
METOCLOPRAMIDE
Oral forms, suppositories, injectable forms
COMPANY CORE DATA SHEET
REFERENCED VERSION
FOR INTERNAL USE ONLY
Approval Date: 20 dec 2013
Version: 8.0
Total number of pages:16
Revision Date:
Metoclopramide-CCDSV8-LRC-20Dec2013
.doc
Property of the Sanofi group - strictly confidential
Page 2
GENERAL INFORMATION
A Company Core Data Sheet (CCDS) is the company internal basis for
development and maintenance
of local labeling (i.e., prescribing information, patient
information), to ensure consistency of
information between countries.
o
MANDATORY (BOLD)
text:
Part of the information in this document is considered Mandatory
Information (highlighted in bold
print). Mandatory Information is information affiliates are required
to submit to their local regulatory
authorities for inclusion into their local labeling, without any
modification. Exceptions are to be
agreed by Regulatory Labeling. [Note: Bolded headings and sub-headings
are never considered as
mandatory information]
o
Non-Mandatory (Non-Bold) text:
Non-mandatory information does not have to be included in local
labeling, however the local text can
not contradict the information from the CCDS/CCSI.
Exceptions are the Indication and Dosage sections: The Company Core
Data Sheet also contains
information that is not bolded but still is considered mandatory for
submission (e.g., indications and
dosage recommendations for a newly developed product or any new
indication). Again this text is
NOT in bold. The affiliates will be informed accordingly when
receiving the revised CCDS.
The indications and dosage/administration recommendations given in the
CCDS are restricted to those
that are supported by the company, and for which a complete dossier is
available. A regional/country
specific label may contain all of these, or only a subset. Any
significant deviation/modification in the
wording of the(se) indication(s) and dosage/administration
recommendations, including modifications
from discussions with