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EDARBI Tablets (2018)

Active ingredients: Azilsartan medoxomil

Product Name and Form

Edarbi 20 mg tablets.

Edarbi 40 mg tablets.

Edarbi 80 mg tablets.

Pharmaceutical form

Tablet.

Edarbi 20 mg tablets: White to nearly white round tablets, 6.0 mm in diameter, debossed “ASL” on one side and “20” on the other.

Edarbi 40 mg tablets: White to nearly white round tablets, 7.6 mm in diameter, debossed “ASL” on one side and “40” on the other.

Edarbi 80 mg tablets: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.

Qualitative and Quantitative Composition

Edarbi 20 mg tablets: Each tablet contains 20 mg of azilsartan medoxomil (as potassium).

Edarbi 40 mg tablets: Each tablet contains 40 mg of azilsartan medoxomil (as potassium).

Edarbi 80 mg tablets: Each tablet contains 80 mg of azilsartan medoxomil (as potassium).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Azilsartan medoxomil

Azilsartan medoxomil is an orally active prodrug that is rapidly converted to the active moiety, azilsartan, which selectively antagonises the effects of angiotensin II by blocking its binding to the AT1 receptor in multiple tissues. Angiotensin II is the principal pressor agent of the RAAS, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium.

List of excipients

Mannitol (E421)
Fumaric acid (E297)
Sodium hydroxide
Hydroxypropylcellulose (E463)
Croscarmellose sodium
Microcrystalline cellulose (E460)
Magnesium stearate (E572)

Pack sizes and Marketing

Aluminum blisters

Pack sizes: 14, 28, 56 or 98 tablets; or

Aluminum blisters integrated with desiccant.

Pack sizes: 14, 28, 30, 56, 90 or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark

Date of first authorisation: 7 December 2011

Marketing authorization number:

EU/1/11/734/001 14 tablets
EU/1/11/734/002 28 tablets
EU/1/11/734/012 30 tablets
EU/1/11/734/003 56 tablets
EU/1/11/734/013 90 tablets
EU/1/11/734/004 98 tablets
EU/1/11/734/005 14 tablets
EU/1/11/734/006 28 tablets
EU/1/11/734/014 30 tablets
EU/1/11/734/007 56 tablets
EU/1/11/734/015 90 tablets
EU/1/11/734/008 98 tablets
EU/1/11/734/016 14 tablets
EU/1/11/734/009 28 tablets
EU/1/11/734/017 30 tablets
EU/1/11/734/010 56 tablets
EU/1/11/734/018 90 tablets
EU/1/11/734/011 98 tablets
EU/1/11/734/019 14 tablets
EU/1/11/734/020 28 tablets
EU/1/11/734/021 56 tablets
EU/1/11/734/022 98 tablets
EU/1/11/734/023 14 tablets
EU/1/11/734/024 28 tablets
EU/1/11/734/025 56 tablets
EU/1/11/734/026 98 tablets
EU/1/11/734/027 14 tablets
EU/1/11/734/028 28 tablets
EU/1/11/734/029 56 tablets
EU/1/11/734/030 98 tablets