TRAMAL

This brand name is authorized in Australia, Austria, Brazil, Croatia, Ecuador, Estonia, Finland, Germany, Israel, Japan, Netherlands, New Zealand, Poland, Romania, South Africa, Tunisia.

Active ingredients

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

1	Tramadol UNII 9N7R477WCK - TRAMADOL HYDROCHLORIDE
	Tramadol is a centrally acting opioid analgesic. It is a non selective pure agonist at μ-, δ- and κ-opioid receptors with a higher affinity for the μ-receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect.
	Read more about Tramadol

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TRAMAL Capsule, Solution for injection, Tablet	MPI, EU: SmPC	Medicines and Medical Devices Safety Authority (NZ)

Medicine classification

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

ATC Group		Classification
N02AX02	Tramadol	N Nervous system → N02 Analgesics → N02A Opioids → N02AX Other opioids
Discover more medicines within N02AX02

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	12008B, 12024W, 2527B, 3484J, 5150C, 5231H, 5232J, 8455B, 8523N, 8524P, 8525Q, 8582Q, 8843K
BR	Câmara de Regulação do Mercado de Medicamentos	542815070000613, 542815070000713, 542815070000813, 542815070000913, 542815070001013, 542815070001103, 542815070001303, 542815070001403, 542820020005807, 542820020005907, 542820020006007, 542820020006107, 542820020006207, 542820020006307
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00698360, 00698377, 00698383, 00955041, 00955058, 00955064, 00955070, 00955087, 00955093, 02029172, 02256100, 02256175, 02364427, 02729194, 02729202, 04994486, 06867645, 07186284, 07428824, 07428876, 11054536, 11236102, 11236119, 11236148, 11236208, 12910871
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	03653-MAN-05-05, 03659-MAN-06-05, 03823-MAN-08-05, 24.975-02-03, 5.537-3-12-02, 5.605-3-03-03, 7.988-1-05-03
EE	Ravimiamet	1015377, 1015399, 1041534, 1041545, 1041556, 1075890, 1075902, 1075913, 1075924, 1075935, 1075946, 1114917, 1114928, 1249152
FI	Lääkealan turvallisuus- ja kehittämiskeskus	014422, 155770, 155911, 179374, 435115, 435156, 435172, 435206, 435214, 435222, 488411, 565663, 569418, 569459
HR	Agencija za lijekove i medicinske proizvode	HR-H-065187023, HR-H-170945872, HR-H-210396637, HR-H-286762123, HR-H-296852819, HR-H-505350700, HR-H-610358597, HR-H-722830373
IL	מִשְׂרַד הַבְּרִיאוּת	4815, 4818, 6960
JP	医薬品医療機器総合機構	1149038F1024, 1149038F2020, 1149400A1049
NL	Z-Index G-Standaard	13678388, 13890239
NL	Z-Index G-Standaard, PRK	35203, 35475, 40967, 50431, 50458, 50466
NZ	Medicines and Medical Devices Safety Authority	11482, 12220, 7777, 7778, 7779, 8990, 8991, 8992
PL	Rejestru Produktów Leczniczych	100000824, 100067403, 100067410, 100067455, 100082785, 100083603, 100195160, 100227137, 100467155
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63389001, W63389002, W63390001, W63390002, W63391001, W63391003
TN	Direction de la Pharmacie et du Médicament	9253301, 9253302, 9253303, 9253304, 9253305
ZA	Health Products Regulatory Authority	31/2.9/0646, 31/2.9/0647, 42/2.9/0283, S/2.0/290, S/2.9/289