List of medicinal products under additonal monitoring

avoided, the dose of pirfenidone should be reduced to 1602 mg daily (two capsules, three times a day) Esbriet should be used with caution when ciprofloxacin is used at a dose of 250 mg or 500mg once or two times a day Esbriet should be used with caution in patients treated with other moderate inhibitors of CYP1A2 (e g amiodarone, propafenone)

Esbriet - European Medicines Agency

Esbriet pirfenidone On 16 December 2010 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Esbriet, hard capsules, 267 mg intended for treatment of idiopathic pulmonary fibrosis (IPF) Esbriet was

Fewer pills, more flexibility in dosing: Roche’s new Esbriet

Jun 27, 2017 · Esbriet is conditionally recommended for use in people with IPF in the ATS / ERS / JRS / ALAT treatment guidelines published in July 2015 18 Pirfenidone has been marketed as Pirespa since 2008 in Japan and since 2012 in South Korea by Shionogi & Co Ltd Under different trade names, pirfenidone is also approved for the

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Esbriet 267 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 267 mg pirfenidone For a full list of excipients, see section 6 1 3 PHARMACEUTICAL FORM Hard capsule (capsule) Two piece capsules with a blue opaque body and gold opaque cap imprinted with “InterMune 267 mg”

Results of a six-month study combining Roche’s Esbriet with

Sep 13, 2017 · Esbriet is conditionally recommended for use in people with IPF in the ATS / ERS / JRS / ALAT treatment guidelines published in July 2015 13 Pirfenidone has been marketed as Pirespa since 2008 in Japan and since 2012 in South Korea by Shionogi & Co Ltd Under different trade names, pirfenidone is also approved for the

I PIELIKUMS ZĀĻU APRAKSTS - European Commission

Esbriet 267 mg cietās kapsulas 2 KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS Katra kapsula satur 267 mg pirfenidona (pirfenidone) Pilnu palīgvielu sarakstu skatīt 6 1 apakšpunktā 3 ZĀĻU FORMA Cietā kapsula (kapsula) Divdaļīgas kapsulas ar baltu necaurspīdīgu korpusu un baltu necaurspīdīgu vāciņu ar brūnu uzrakstu