IFIRMASTA Film-coated tablet Ref.[27905] Active ingredients: Irbesartan

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Ifirmasta 75 mg film-coated tablets.

Ifirmasta 150 mg film-coated tablets.

Ifirmasta 300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, oval tablets.

Qualitative and quantitative composition

Ifirmasta 75 mg film-coated tablets: Each film-coated tablet contains 75 mg irbesartan (as hydrochloride).

Ifirmasta 150 mg film-coated tablets: Each film-coated tablet contains 150 mg irbesartan (as hydrochloride).

Ifirmasta 300 mg film-coated tablets: Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).

Excipient with known effect:

Ifirmasta 75 mg film-coated tablets: Each film-coated tablet contains 4 mg castor oil.

Ifirmasta 150 mg film-coated tablets: Each film-coated tablet contains 8 mg castor oil.

Ifirmasta 300 mg film-coated tablets: Each film-coated tablet contains 16 mg castor oil.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Irbesartan

Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
List of Excipients

Tablet core:

Mannitol
Hydroxypropylcellulose
Low-substituted Hydroxypropyl Cellulose (LH-21)
Low-substituted Hydroxypropyl Cellulose (LH-11)
Talc
Macrogol 6000
Castor oil, hydrogenated

Film coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3000
Talc

Pack sizes and marketing

Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available.

Blister (PVC/PE/PVDC/Alu): 56 × 1 film-coated tablets in perforated unit dose blisters in 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

Ifirmasta 75 mg film-coated tablets:

14 tablets: EU/1/08/480/001
28 tablets: EU/1/08/480/002
30 tablets: EU/1/08/480/019
56 tablets: EU/1/08/480/003
56 × 1 tablets: EU/1/08/480/004
84 tablets: EU/1/08/480/005
90 tablets: EU/1/08/480/020
98 tablets: EU/1/08/480/006

Ifirmasta 150 mg film-coated tablets:

14 tablets: EU/1/08/480/007
28 tablets: EU/1/08/480/008
30 tablets: EU/1/08/480/021
56 tablets: EU/1/08/480/009
56 × 1 tablets: EU/1/08/480/010
84 tablets: EU/1/08/480/011
90 tablets: EU/1/08/480/022
98 tablets: EU/1/08/480/012

Ifirmasta 300 mg film-coated tablets:

14 tablets: EU/1/08/480/013
28 tablets: EU/1/08/480/014
30 tablets: EU/1/08/480/023
56 tablets: EU/1/08/480/015
56 × 1 tablets: EU/1/08/480/016
84 tablets: EU/1/08/480/017
90 tablets: EU/1/08/480/024
98 tablets: EU/1/08/480/018

Date of first authorisation: 1 December 2008
Date of latest renewal: 26 August 2013

Drugs

Drug Countries
IFIRMASTA Albania, Austria, Germany, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom
 
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