TOLURA Tablet Ref.[27724] Active ingredients: Telmisartan

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Tolura 40 mg tablets.

Pharmaceutical Form

Tablet.

40 mg: white to almost white, biconvex, oval tablets.

Qualitative and quantitative composition

Each tablet contains 40 mg telmisartan.

Excipients with known effect:

Each tablet contains 149.8 mg sorbitol (E420) and 57 mg lactose.

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 (K30)
Meglumine
Sodium hydroxide
Lactose monohydrate
Sorbitol (E420)
Magnesium stearate

Pack sizes and marketing

OPA/Al/PVC Al blister. Each blister contains 7 or 10 tablets.

Pack sizes: 14, 28, 30, 56, 84, 90, 98 and 100 tablets in a box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

14 tablets: EU/1/10/632/008
28 tablets: EU/1/10/632/009
30 tablets: EU/1/10/632/010
56 tablets: EU/1/10/632/011
84 tablets: EU/1/10/632/012
90 tablets: EU/1/10/632/013
98 tablets: EU/1/10/632/014
100 tablets: EU/1/10/632/023

Date of first authorisation: 4 June 2010
Date of latest renewal: 19 March 2015

Drugs

Drug Countries
TOLURA Albania, Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, Singapore, United Kingdom
 
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