Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Oroxine 25 microgram tablets.
| Pharmaceutical Form |
|---|
|
Tablets. Levothyroxine sodium 25 microgram tablets are round, 6.5mm in diameter, white coloured, flat, bevelled tablets debossed with ‘25’ on the one side and a breakline on the other side. The tablet can be divided into equal doses. |
Each tablet of Oroxine 25 microgram contains 27.8 microgram of levothyroxine sodium pentahydrate equivalent to 25 microgram of levothyroxine sodium.
For the 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 |
|---|
|
Microcrystalline cellulose PH101 (E460) |
High density polyethylene (HDPE) bottles, closed with white polypropylene (PP) screw caps with foil heat induction seals, and with a 1.0 g white polypropylene canister containing oxygen absorber. The canister (oxygen absorber) should remain inside the bottle during the in-use period.
For Oroxine 25 and 50 microgram tablets: 28, 50, 60 tablets.
For Oroxine 75, 100, 125, 150, 175, 200 microgram tablets: 28, 50, 60, 84, 90, 100, 112 tablets.
Not all pack sizes may be marketed.
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
PA1691/013/001
Date of first authorisation: 12th September 2014
Date of last renewal: 10th April 2019
| Drug | Countries | |
|---|---|---|
| OROXINE | Austria, Australia, Hong Kong, Ireland, Poland |
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