Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Esbriet 267 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder. |
Each capsule contains 267 mg pirfenidone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pirfenidone |
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. Pirfenidone is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Titanium dioxide (E171) Printing Inks: Brown S-1-16530 or 03A2 inks containing: Shellac |
2-week treatment initiation pack: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing). Each pack contains a total of 63 capsules.
4-week treatment maintenance pack: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply). There are 14 × 18 capsules in PVC/PE/PCTFE aluminium foil perforated blister strips for a total of 252 capsules per pack.
250 ml white HDPE bottle with child-resistant closure containing 270 capsules.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/11/667/001
EU/1/11/667/002
EU/1/11/667/003
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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