TRANDATE

This brand name is authorized in Australia, Austria, Canada, Cyprus, Estonia, France, Hong Kong SAR China, Ireland, Israel, Japan, Malta, Netherlands, New Zealand, Singapore, South Africa, Spain, UK.

Active ingredients

The drug TRANDATE contains one active pharmaceutical ingredient (API):

1
UNII 1GEV3BAW9J - LABETALOL HYDROCHLORIDE
 

Labetalol lowers the blood pressure by blocking peripheral arteriolar alphaadrenoceptors thus reducing peripheral resistance, and by concurrent betablockade, protects the heart from reflex sympathetic drive that would otherwise occur.

 
Read more about Labetalol

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 TRANDATE Film-coated tablet MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
C07AG01 Labetalol C Cardiovascular system → C07 Beta blocking agents → C07A Beta blocking agents → C07AG Alpha and beta blocking agents
Discover more medicines within C07AG01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 1566K, 1567L
CA Health Products and Food Branch 02106272, 02106280
EE Ravimiamet 1007312, 1007828, 1680498
ES Centro de información online de medicamentos de la AEMPS 54527, 54528, 55318
FR Base de données publique des médicaments 60558554, 65193337
GB Medicines & Healthcare Products Regulatory Agency 13901, 13902, 13930, 13933, 13972, 21622
HK Department of Health Drug Office 02799, 02800, 02802, 57922
IE Health Products Regulatory Authority 69787, 69795, 69809, 69817, 69833, 69841
IL מִשְׂרַד הַבְּרִיאוּת 285, 286, 4348
JP 医薬品医療機器総合機構 2149009F1030, 2149009F2037
MT Medicines Authority AA565/04502, AA565/04503, AA729/12804, AA729/12805, AA770/14401
NL Z-Index G-Standaard 12303968
NL Z-Index G-Standaard, PRK 15024
NZ Medicines and Medical Devices Safety Authority 20892, 20893, 2418
SG Health Sciences Authority 02281P
ZA Health Products Regulatory Authority J/7.1.3/52, J/7.1.3/54

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