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818 results

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Dear Doctor Letter (Rote-Hand-Brief) on Sildenafil (Revatio® and Viagra®): should not be used to treat intrauterine growth restriction PDF, 165KB, File is accessible Date: 11. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sildenafil

The STRIDER clinical trial, which was studying sildenafil for treating intrauterine growth restriction (IUGR), has been prematurely discontinued due to a higher incidence of persistent pulmonary hypertension of the newborn (PPHN) and overall …

Dear Doctor Letter (Rote-Hand-Brief) on Rivaroxaban (Xarelto®): increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in a prematurely stopped clinical trial PDF, 163KB, File is accessible Date: 02. October 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rivaroxaban

A phase III clinical study, 17938 (GALILEO), conducted in patients after transcatheter aortic valve replacement (TAVR) has been terminated ahead of schedule based on preliminary results showing an increase in all-cause mortality, …

Dear Doctor Letter (Rote-Hand-Brief) on hydroxyethyl starch (HES) solutions for infusion: new measures to reinforce existing restrictions due to increased risk of renal dysfunction and mortality in critically ill or septic patients PDF, 231KB, File is accessible Date: 13. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl stark, HES

The marketing authorisation holders inform that hydroxyethyl starch (HES)-containing solutions for infusion have continued to be used in patients with contraindications. Such contraindicated use is associated with a risk for serious harm, …

Risk Management Plans (RMP) Date: 13. August 2018 Topics: Pharmakovigilanz Type: Article

Submission of Risk Management Plans (RMP) within the Framework of Regulatory Actions (Marketing authorization applications, Renewals and Variations)

Dear Doctor Letter (Rote-Hand-Brief) on radium-223-dichloride (Xofigo): new restrictions due to increased risk of fractures and possible increased risk of death PDF, 139KB, File is accessible Date: 06. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Radium-223-dichlorid

The use of Xofigo is associated with an increased risk of fractures. A possible increased risk of death was also observed in a clinical trial investigating radium-223 dichloride (Xofigo) in combination with abiraterone acetate and …

Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury Date: 03. August 2018 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.

Dear Doctor Letter (Rote-Hand-Brief) on ulipristal acetate (Esmya®): restricted indication, new contraindication and requirements for liver monitoring PDF, 430KB, File is accessible Date: 03. August 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Ulipristalacetat

Restricted indication, new contraindication and requirements for liver monitoring.

Dear Doctor Letter (Rote-Hand-Brief) on Spinraza (nusinersen): communicating hydrocephalus not related to meningitis or bleeding reported PDF, 306KB, File is accessible Date: 31. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nusinersen

The marketing authorization holder, Biogen, informs of the occurrence of communicating hydrocephalus not related to meningitis or bleeding under treatment with Spinraza. Biogen informs on several measures that should be followed.

Information Letter on Fiasp® (insulin aspart): new colour scheme for cartridges and pre-filled pens PDF, 291KB, File is accessible Date: 06. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin aspart

The company Novo Nordisk Pharma GmbH is circulating information on the fact that a new colour scheme will be introduced for Fiasp® products as of July 2018 in order to improve their discernibility from Tresiba®.

Dear Doctor Letter (Rote-Hand-Brief) on finasteride: risk of sexual dysfunction and psychiatric symptoms PDF, 2MB, File is accessible Date: 05. July 2018 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: finasterid

Marketing Authorization Holders are circulating information on the risk of developing sexual dysfunctions and psychiatric symptoms under treatment with finasteride.