EUTHYROX Tablet Ref.[50789] Active ingredients: Levothyroxine

Source: Marketing Authorisation Holder Revision Year: 2018 Publisher: Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

Product name and form

Euthyrox 25 microgram tablets.
Euthyrox 50 microgram tablets.
Euthyrox 75 microgram tablets.
Euthyrox 88 microgram tablets.
Euthyrox 100 microgram tablets.
Euthyrox 112 microgram tablets.
Euthyrox 125 microgram tablets.
Euthyrox 137 microgram tablets.
Euthyrox 150 microgram tablets.
Euthyrox 175 microgram tablets.
Euthyrox 200 microgram tablets.

Pharmaceutical Form
Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription on top: Euthyrox 25 microgram EM 25 Euthyrox 50 microgram EM 50 Euthyrox 75 microgram EM 75 Euthyrox 88 microgram EM 88 Euthyrox 100 microgram EM 100 Euthyrox 112 microgram EM 112 Euthyrox 125 microgram EM 125 Euthyrox 137 microgram EM 137 Euthyrox 150 microgram EM 150 Euthyrox 175 microgram EM 175 Euthyrox 200 microgram EM 200 The tablet can be divided into equal doses.

Qualitative and quantitative composition

1 tablet Euthyrox 25 microgram contains 25 microgram levothyroxine sodium.
1 tablet Euthyrox 50 microgram contains 50 microgram levothyroxine sodium.
1 tablet Euthyrox 75 microgram contains 75 microgram levothyroxine sodium.
1 tablet Euthyrox 88 microgram contains 88 microgram levothyroxine sodium.
1 tablet Euthyrox 100 microgram contains 100 microgram levothyroxine sodium.
1 tablet Euthyrox 112 microgram contains 112 microgram levothyroxine sodium.
1 tablet Euthyrox 125 microgram contains 125 microgram levothyroxine sodium.
1 tablet Euthyrox 137 microgram contains 137 microgram levothyroxine sodium.
1 tablet Euthyrox 150 microgram contains 150 microgram levothyroxine sodium.
1 tablet Euthyrox 175 microgram contains 175 microgram levothyroxine sodium.
1 tablet Euthyrox 200 microgram contains 200 microgram levothyroxine sodium.

Excipients: Contains lactose, see section 4.4.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Levothyroxine	Levothyroxine sodium is used for the treatment of hypothyroidism. The chief action of levothyroxine is to increase the rate of cell metabolism.

List of Excipients
Maize starch Citric acid, anhydrous Croscarmellose sodium Gelatine Magnesium stearate Mannitol (E421)

Pack sizes and marketing

Blister pack: Polypropylene base film and aluminium cover foil, or alternatively PVC base film with aluminium cover foil.

Pack size:

cartons of 20, 25, 30, 50, 60, 90, and 100 tablets,
calendar packs of 28 and 84 tablets,
hospital packs: 500 (10 × 50) tablets.

Additionally for Euthyrox 25 / 50 / 100 microgram tablets

Bottles: HDPE bottle with a polypropylene screw cap.

Pack sizes:

hospital packs: 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

Marketing authorization dates and numbers

Date of first authorization: 25/11/2002

Drugs

Drug	Countries
EUTHYROX	Austria, Brazil, Cyprus, Germany, Estonia, Croatia, Israel, Malta, Nigeria, Netherlands, Poland, Romania, Singapore, Turkey, United States, South Africa

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