Has an application for variation in the indication, recommended dosage or similar been submitted? no yes (dd.mm.yyyy) Is a variation of the product information pending? no yes (dd.mm.yyyy) During the period covered by the PSUR, were safety-related variations approved made outside Switzerland (EU , of an EU Member US PI), or are any safety-related variations currently being reviewed? no yes please explain → Is there need for action in Switzerland based on the data contained in the PSUR? no yes please explain → Comments The information provided herewith is certified to be accurate and complete. (Official stamp of the applicant / authorisation holder) Mandatory Optional Place, date Ort, Datum Person responsible Other person Name Name First name First name Job title Job title Telephone E-Mail This PSUR / PBRER should be sent to For related questions Swissmedic, Swiss Agency for Therapeutic Products Tel: +41 58 462 03 52 P.O. Box, Hallerstrasse 7,3000 Bern 9 Fax: +41 58 462 04 18 E-Mail: Mandatory elements of a Periodic Report IN accordance with the TPO Format in line with the Guideline E2C (R2) guideline E2C (R2) on periodic benefit-risk evaluation „ICH report (PBRER)“, January 2013 or ICH Guideline E2C Safety Data Management: Periodic Safety “Clinical Update Reports for Marketed Drugs“. PSUR and all documentation included must be submitted in an official language of Switzerland or in English.
Has an application for variation in the indication, recommended dosage or similar been submitted? no yes (dd.mm.yyyy) Is a variation of the product information pending? no yes (dd.mm.yyyy) During the period covered by the PSUR, were safety-related variations approved made outside Switzerland (EU , of an EU Member US PI), or are any safety-related variations currently being reviewed? no yes → please explain Is there need for action in Switzerland based on the data contained in the PSUR? no yes → please explain Comments The information provided herewith is certified to be accurate and complete. (Official stamp of the applicant / authorisation holder) Mandatory Optional Place, date Person responsible Name First name Job title Telephone E-Mail Ort, Datum Other person Name First name Job title This PSUR / PBRER should be sent to Swissmedic, Swiss Agency for Therapeutic Products P.O. Box, Hallerstrasse 7,3000 Bern 9 For related questions Tel: +41 58 462 03 52 Fax: +41 58 462 04 18 E-Mail: Mandatory elements of a Periodic Report IN accordance with the TPO Format in line with the Guideline E2C (R2) „ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)“, January 2013 or ICH Guideline E2C “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs“. PSUR and all documentation included must be submitted in an official language of Switzerland or in English.
mu103_10_001e_fopsurpbrerformforhumanmedicines.docx