Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Micardis 20 mg tablets.
Micardis 40 mg tablets.
Micardis 80 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Micardis 20 mg tablets: White round tablets of 2.5 mm engraved with the code number ‘50H’ on one side and the company logo on the other side. Micardis 40 mg tablets: White oblong tablets of 3.8 mm engraved with the code number ‘51H’ on one side and the company logo on the other side. Micardis 80 mg tablets: White oblong tablets of 4.6 mm engraved with the code number ‘52H’ on one side and the company logo on the other side. |
Micardis 20 mg tablets: Each tablet contains 20 mg telmisartan.
Micardis 40 mg tablets: Each tablet contains 40 mg telmisartan.
Micardis 80 mg tablets: Each tablet contains 80 mg telmisartan.
Excipients with known effect:
Each 20 mg tablet contains 84 mg sorbitol (E420).
Each 40 mg tablet contains 169 mg sorbitol (E420).
Each 80 mg tablet contains 338 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Telmisartan |
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting. |
| List of Excipients |
|---|
|
Povidone (K25) |
Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al). One blister contains 7 or 10 tablets.
Micardis 20 mg tablets:
Pack sizes: Blister with 14, 28, 56 or 98 tablets.
Micardis 40 mg and 80 mg tablets:
Pack sizes: Blister with 14, 28, 56, 84 or 98 tablets or perforated unit dose blisters with 28 × 1, 30 × 1 or 90 × 1 tablets; multipacks containing 360 (4 packs of 90 × 1) tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Micardis 20 mg tablets:
EU/1/98/090/009 (14 tablets)
EU/1/98/090/010 (28 tablets)
EU/1/98/090/011 (56 tablets)
EU/1/98/090/012 (98 tablets)
Micardis 40 mg tablets:
EU/1/98/090/001 (14 tablets)
EU/1/98/090/002 (28 tablets)
EU/1/98/090/003 (56 tablets)
EU/1/98/090/004 (98 tablets)
EU/1/98/090/013 (28 × 1 tablets)
EU/1/98/090/015 (84 tablets)
EU/1/98/090/017 (30 × 1 tablets)
EU/1/98/090/019 (90 × 1 tablets)
EU/1/98/090/021 (4 x (90 × 1) tablets)
Micardis 80 mg tablets:
EU/1/98/090/005 (14 tablets)
EU/1/98/090/006 (28 tablets)
EU/1/98/090/007 (56 tablets)
EU/1/98/090/008 (98 tablets)
EU/1/98/090/014 (28 × 1 tablets)
EU/1/98/090/016 (84 tablets)
EU/1/98/090/018 (30 × 1 tablets)
EU/1/98/090/020 (90 × 1 tablets)
EU/1/98/090/022 (4 x (90 × 1) tablets)
Date of first authorisation: 16 December 1998
Date of last renewal: 16 December 2008
| Drug | Countries | |
|---|---|---|
| MICARDIS | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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