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819 results

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Rote-Hand-Brief on Kepivance® PDF, 2MB, File does not meet accessibility standards Date: 20. April 2010 Topics: Pharmakovigilanz Type: Download

Active substance: palifermin

Dear Doctor Letter (Rote-Hand-Brief) on Kepivance®: Restriction of indication PDF, 2MB, File is accessible Date: 20. April 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: palifermin

Indication for Kepivance® restricted to patients exposed to radiotherapy and chemotherapy for conditioning prior to autologous stem cell transplantation.

Dextromethorphane (DXM): Growing number of reports on misuse in 2009. Pharmacies are recommended to sell with caution. Date: 16. April 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: dextromethorphane

In 2009 the BfArM received a noticeably increased number of reports on (suspected) misuse of dextromethorphane products compared with previous years.

Antragsformular Variation Statine doc, 115KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Antragsformular Variation Statine

Formblatts Änderungsanzeige Statine doc, 67KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Formblatts Änderungsanzeige Statine

PhVWP Report PDF, 63KB, File does not meet accessibility standards Date: 07. April 2010 Topics: Pharmakovigilanz Type: Download

Pharmacovigilance Working Party Report

Yasmin® and venous thrombosis: Update of product information Date: 29. March 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: drospirenone

Data from two studies into the risk of venous thromboembolic incidents due to the use of combined oral contraceptives containing drospirenone, have been evaluated by the Pharmacovigilance Working Party of the European Medicines Agency EMA.

Tamoxifen: Interaction with SSRIs (selective serotonin reuptake inhibitors) Date: 18. March 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: tamoxifen

A Canadian cohort study showed that the SSRI, paroxetin, may decrease the effect of tamoxifen in a hormone therapy of mamma carcinoma (BMJ 2010; 340:c693). Concomitant administration of tamoxifen and paroxetin was found to increase breast …

Rote-Hand-Brief on REGRANEX® PDF, 79KB, File does not meet accessibility standards Date: 15. March 2010 Topics: Pharmakovigilanz Type: Download

Active substance: becaplermine

Dear Doctor Letter (Rote-Hand-Brief) on REGRANEX®: Extension of existing contraindications PDF, 79KB, File is accessible Date: 15. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

REGRANEX® (active substance: becaplermin) contraindicated for patients with malign diseases.