EUTHYROX

This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Croatia, Cyprus, Estonia, Germany, Israel, Malta, Netherlands, Poland, Romania, Singapore, South Africa, Turkey, United States.

Active ingredients

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

1	Levothyroxine UNII 9J765S329G - LEVOTHYROXINE SODIUM
	Levothyroxine sodium is used for the treatment of hypothyroidism. The chief action of levothyroxine is to increase the rate of cell metabolism.
	Read more about Levothyroxine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-0147	Tablet	Euthyrox 100 mcg Tablet TAB 100 mcg 4 x 25's (in PVC/Aluminium blisters)	Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription "EM 100" on one side. The tablet can be divided into equal doses	25/09/2024
A4-0160	Tablet	Euthyrox 50 mcg Tablet TAB 50 mcg 4 x 25's (in PVC/Aluminium blisters)	Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription "EM 50" on one side. The tablet can be divided into equal doses	25/09/2024
A4-0161	Tablet	Euthyrox 25 mcg Tablet TAB 25 mcg 4 x 25's (in PVC/Aluminium blisters)	Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription "EM 25" on one side. The tablet can be divided into equal doses	25/09/2024
A4-101015	Tablet	Euthyrox 75 mcg Tablet TAB 75 mcg 2 x 15's (in PVC/Aluminium blisters)	Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription "EM 75" on one side. The tablet can be divided into equal doses	25/09/2024

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
EUTHYROX Tablet	MPI, EU: SmPC	Marketing Authorisation Holder

Medicine classification

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

ATC Group		Classification
H03AA01	Levothyroxine sodium	H Systemic hormonal preparations, excl. Sex hormones and insulins → H03 Thyroid therapy → H03A Thyroid preparations → H03AA Thyroid hormones
Discover more medicines within H03AA01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	525404125112419, 525404126119417, 525404127115415, 525404128111413, 525404129118411, 525404130116419, 525404131112417, 525404132119415, 525404133115413, 525404134111411, 525404135118312, 525418120050503, 525418120050603, 525418120050703, 525418120050803, 525418120050903, 525418120051003, 525418120051103, 525418120051203, 525418120051303, 525418120051403, 525418120051503
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	01916681, 01916706, 01916729, 02050605, 02050640, 02050692, 02198012, 02292194, 02292202, 02361819, 02754677, 02754708, 02754737, 02754766, 02754795, 02754826, 02754855, 02754861, 02754878, 02754884, 03542291, 03542322, 09714250, 17267210
EE	Ravimiamet	1102600, 1706352, 1827121
HR	Agencija za lijekove i medicinske proizvode	HR-H-012640690, HR-H-049751832, HR-H-261403751, HR-H-303506536, HR-H-531410473, HR-H-628995193, HR-H-853297728, HR-H-867485518
IL	מִשְׂרַד הַבְּרִיאוּת	8195, 8196, 9422
MT	Medicines Authority	AA565/80601, AA565/80602
NG	Registered Drug Product Database	A4-0147, A4-0160, A4-0161, A4-101015
NL	Z-Index G-Standaard, PRK	15784, 15792, 23469, 24783, 34894, 48941, 60992, 61018, 90670, 90689, 90697
PL	Rejestru Produktów Leczniczych	100122250, 100122266, 100122303, 100122310, 100122326, 100122332, 100122349, 100122361, 100213454, 100213477, 100213483, 100262725
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66290002, W66291003, W66292003, W66293002, W66294002, W67515001, W67515002, W67516001, W67516002
SG	Health Sciences Authority	09739P, 09740P, 09741P, 11536P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699808010032, 8699808010049, 8699808010056, 8699808010063, 8699808010070, 8699808010087, 8699808010094, 8699808010100
US	FDA, National Drug Code	72305-025, 72305-050, 72305-075, 72305-088, 72305-100, 72305-112, 72305-125, 72305-137, 72305-150, 72305-175, 72305-200
ZA	Health Products Regulatory Authority	52/21.3/0440, A39/21.3/0401, A39/21.3/0402, A39/21.3/0403