BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on the use of intrauterine devices (IUDs): Risk of uterine perforation PDF, 436KB, File is accessible Date: 23. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levonorgestrel

In view of updated results of the "European Active Surveillance Study for Intrauterine Devices” (EURAS-IUD), the company Jenapharm GmbH & Co. KG is circulating information on the investigation of the use of copper-bearing intrauterine …

Petnidan® Syrup, 50 mg/ml oral solution: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 15. July 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: ethosuximide

The BfArM has received information that counterfeit packs of the medicinal product Petnidan® Syrup, 50 mg/ml oral solution (Marketing Authorisation Holder: Desitin Arzneimittel GmbH) are on the market in Turkey in German packaging.

Information Letter on Dacogen 50 mg, powder for concentrate for solution for infusion: Changes regarding instructions for reconstitution and shelf life PDF, 555KB, File is accessible Date: 10. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: decitabine

The company Janssen-Cilag GmbH is circulating information on measures to improve stability for reconstitution and shelf life of Dacogen.

Information Letter on SGLT2 inhibitors: Risk of diabetic ketoacidosis PDF, 186KB, File is accessible Date: 10. July 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: canagliflozin, capagliflozin, empagliflozin

The companies AstraZeneca AB, Boehringer Ingelheim International GmbH and Janssen-Cilag International N.V. are circulating information on the risk of diabetic ketoacidosis under treatment with SGLT2 inhibitors.

Viagra®: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany Date: 02. July 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Sildenafil

The Italian authority AIFA has informed the BfArM that the customs in Italy confiscated counterfeit medicinal products of the company Pfizer's prescription-only potency drug Viagra® 100 mg film-coated tablets.

Saxagliptin: EMA investigates irregularities in large cardiovascular study (SAVOR) Date: 25. June 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Saxagliptin

On its website, the French supervisory authority (ANSM) has reported a possibly increased mortality due to infections during the course of a study performed with the active substance saxagliptin (SAVOR: Saxagliptin Assessment of Vascular …

SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis Date: 16. June 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

Information letter on Corotrop® 10 mg/10 ml solution for injection: Shortage PDF, 22KB, File is accessible Date: 16. June 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: milrinone

The company Sanofi-Aventis Deutschland GmbH is circulating information that the medicinal product Corotrop® 10 mg/10 ml solution for injection is temporarily not available due to capacity issues at the manufacturing site.

Information letter on Kineret® (anakinra) 100 mg and 100 mg/0.67 ml solution for injection in a pre-filled syringe: Visible solid deposits on the surface of the needle PDF, 155KB, File is accessible Date: 16. June 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anakinra

The Swedish company Orphan Biovitrum AB (Sobi) issues information on deposits of the active substance on the surface of the needle.

Hydroxyzine: effects on heart rhythm Date: 20. May 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyzine

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.