Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Esbriet 267 mg film-coated tablets.
Esbriet 534 mg film-coated tablets.
Esbriet 801 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with "PFD". Esbriet 534 mg film-coated tablets are orange, oval, approximately 1.6 x 0.8 cm biconvex film-coated tablets, debossed with "PFD". Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with "PFD". |
Each film-coated tablet contains 267 mg pirfenidone.
Each film-coated tablet contains 534 mg pirfenidone.
Each film-coated tablet contains 801 mg pirfenidone.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Pirfenidone attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokine growth factors such as, transforming growth factor-beta (TGF-β) and platelet-derived growth factor (PDGF). |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coat: Polyvinyl alcohol 267 mg tablet Iron oxide yellow (E172) 534 mg tablet Iron oxide yellow (E172) 801 mg tablet Iron oxide red (E172) |
267 mg film-coated tablets:
1 bottle containing 90 film-coated tablets
2 bottles each containing 90 film-coated tablets (180 film-coated tablets in total)
534 mg film-coated tablets:
1 bottle containing 21 film-coated tablets
1 bottle containing 90 film-coated tablets
801 mg film-coated tablets:
1 bottle containing 90 film-coated tablets
267 mg film-coated tablets:
1 blister containing 21 film-coated tablets (21 in total)
2 blisters each containing 21 film-coated tablets (42 in total)
4 blisters each containing 21 film-coated tablets (84 in total)
8 blisters each containing 21 Film-coated tablets (168 in total)
2-week treatment initiation pack: multipack containing 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) film-coated tablets
Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
801 mg film-coated tablets:
4 blisters each containing 21 film-coated tablets (84 in total)
Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/11/667/007
EU/1/11/667/008
EU/1/11/667/009
EU/1/11/667/010
EU/1/11/667/011
EU/1/11/667/012
EU/1/11/667/013
EU/1/11/667/014
EU/1/11/667/015
EU/1/11/667/016
EU/1/11/667/017
EU/1/11/667/018
EU/1/11/667/019
Date of first authorisation: 28 February 2011
Date of latest renewal: 08 September 2015
| Drug | Countries | |
|---|---|---|
| ESBRIET | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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