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Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German) PDF, 258KB, File does not meet accessibility standards Date: 27. April 2020 Topics: Pharmakovigilanz Type: Download

Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German)

Dear Doctor Letter (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Dear Doctor Letter (available in German only)

Information for patients (available in German only) PDF, 2MB, File is accessible Date: 10. April 2019 Topics: Pharmakovigilanz Type: Download

Information for patients (available in German only)

Notification of the Stufenplanbeauftragter rtf, 265KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

According to § 63a subparagraph 3 of the German Medicines Act (AMG), pharmaceutical entrepreneurs are obligated to notify a Stufenplanbeauftragter to the competent authority, the responsible regional authority and, if necessary, also to the …

Notification of a change to the Stufenplanbeauftragter rtf, 299KB, File does not meet accessibility standards Date: 06. June 2018 Topics: Pharmakovigilanz Type: Form

In addition to the obligation to notify a Stufenplanbeauftragter (officer/commissioner of the graduated plan), an alteration or change of the Stufenplanbeauftragter must also be notified. The procedure of notification of a change is identical to the …

Final SmPC and PL wording agreed by the PhVWP December 2011 PDF, 44KB, File is accessible Date: 14. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP December 2011

Final SmPC and PL wording agreed by the PhVWP in September 2011 PDF, 59KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP in September 2011

Final SmPC and PL wording Agreed by PhVWP in June 2011 PDF, 487KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording Agreed by PhVWP in June 2011

Citalopram and risk of QT prolongation - Final SmPC and PL wording agreed by the PhVWP in October 2011 PDF, 48KB, File is accessible Date: 10. January 2012 Topics: Pharmakovigilanz Type: Download

Citalopram - SmPC und PL Texte

Final SmPC and PL wording agreed by PhVWP in September 2011 PDF, 14KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

Von der Pharmakovigilance Working Party verabschiedete Texte der Fach- und Gebrauchsinformation