蒙得康膜衣錠

국가: 대만

언어: 중국어

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

환자 정보 전단 환자 정보 전단 (PIL)
22-05-2020
공공 평가 보고서 공공 평가 보고서 (PAR)
15-04-2020

유효 성분:

TOLPERISONE HCL

제공처:

臺灣美強股份有限公司 台北市中山區南京東路二段66號4樓 (12133650)

ATC 코드:

M03BX04

약제 형태:

膜衣錠

구성:

TOLPERISONE HCL (1220001810) MG

패키지 단위:

瓶裝;;鋁箔盒裝

수업:

製 劑

처방전 유형:

須由醫師處方使用

Manufactured by:

LABATEC-PHARMA S.A. 31 RUE DU CARDINAL-JOURNET CH-1217 MEYRIN-GENEVA,SWITZERLAND CH

치료 영역:

tolperisone

치료 징후:

肌肉緊張所發生之症狀、錐體緊張症候群、多發性硬化肌肉痙攣、脊髓炎

제품 요약:

註銷日期: 2020/03/27; 註銷理由: 許可證已逾有效期; 有效日期: 2019/03/16; 英文品名: MYDOCALM FILM COATED TABLETS

승인 상태:

已註銷

승인 날짜:

2014-03-16

환자 정보 전단

                                RECTO
30
Reading
Direction
196
196
175
226
30
Reading
Direction
LABATEC PHARMA
Document:
Department:
Creation date:
Cutting Dimension:
Country:
Laetus Code:
Labatec Pharma, 31, rue du Cardinal Journet CP12 CH-1217 Meyrin 1
(Genève), Switzerland
Packaging Development Dpt: Tel: + 41 22 593 78 28
No Varnish
Pantone Black C
Colors
Colors
Modification made
N° Modification - Date
1 - 07.03.2017
«Sugar coated» changed to «Film Coated Tablets»
2 - 07.03.2017
Design placed on new cut size 175X226 versus 210X297 mm
3 - 08.03.2017
4 - 09.03.2017
5 - 13.03.2017
Cut
NOT33070-B MYDOCALM 100FCT 175X226 TW
File name: Packaging code
Description:
B
Version N°:
User plant:
Labatec CH
Artwork
07.03.2017
Packaging Dvlpt
175x226
Taiwan
196
Requestor checks
FOR ORALS + DIVERS PRODUCTS
Product code
Dosage
Quantity + galenic form + logo
Therapeutic indication on box
Colours
Composition (on box)
Storage conditions (on box)
Language DE+FR±IT, other
Logos: Customer, Swissmedic, (on Box) Labatec (on Box+Label)
Datamatrix and GTIN number (on Box + Label)
Datamatrix and GTIN printed on line (on Box + Label)
Barre code EAN13 (on Box)
Barre code Laetus (on Box + Leaflet)
Variable data format
General presentation
Product name
APPROVAL area (Please sign electronically this doc using Adobe
Acrobat)
VERSO
NOTxxx-x = Labatec Art. code
30
Reading
Direction
196
196
30
Reading
Direction
                                
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