07.04.2015
|
Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®): Progressive multifocal leukoencephalopathy (PML) in connection with the administration of medicinal products containing dimethyl fumarate
Active substance: dimethyl fumarate
The BfArM issues information that in Germany up to now overall 9 cases of PML (progressive multifocal leukoencephalopathy) have been reported in connection with the administration of Fumaderm® and 2 cases in connection with the administration of Tecfidera®.
|
10.04.2015
|
Viread: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
Active substance: tenofovir
The BfArM has received information that counterfeits of the centrally licensed medicinal product Viread 245 mg film-coated tablets are possibly on the market in Germany.
|
24.04.2015
|
Pulmozyme: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
Active substance: dornase alfa
The BfArM has received information that counterfeits of the medicinal product Pulmozyme 2500 U/2.5 ml (nebuliser solution) are possibly on the market in Germany.
|
25.06.2015
|
Saxagliptin: EMA investigates irregularities in large cardiovascular study (SAVOR)
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 Outcomes Recorded in Patients with Diabetes Mellitus Study) to investigate effects on the cardiovascular system.
|
02.07.2015
|
Viagra®: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
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.
|
15.07.2015
|
Petnidan® Syrup, 50 mg/ml oral solution: Possibility of counterfeits of the medicinal product in the legal supply chain in Germany
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.
|
21.08.2015
|
Olysio® (simeprevir) in combination with Sovaldi® (sofosbuvir): Risk of severe arrhythmias if used concomitantly with amiodarone
Active substance: simeprevir, sofosbuvir
In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC) has also revised the medicinal product Olysio® (simeprevir) with regard to the risk of bradycardias.
|
26.10.2015
|
Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®) and progressive multifocal leukoencephalopathy (PML): Conclusion of the variation worksharing
Active substance: Dimethylfumarat
The BfArM issues information that the variation worksharing procedure regarding progressive multifocal leukoencephalopathy in connection with the use of medicinal products containing dimethyl fumarate has been concluded.
|
26.10.2015
|
Mycophenolate (e.g. CellCept®): Strengthening of warnings in order to prevent use during pregnancy
Active substance: mycophenolate
The European Medicines Agency (EMA) has issued a warning that the active substance mycophenolate used in transplantation medicine must not be administered during pregnancy if other treatment alternatives are available.
|
19.11.2015
|
Acitretin and teratogenicity: Compliance with safety measures in women of childbearing potential
Active substance: acitretin
On a European level it is currently being discussed that the 2-year period of pregnancy prevention in patients of childbearing potential is possibly not sufficient and must therefore be extended to 3 years after end of treatment.
|
14.01.2016
|
Mycophenolate (e.g. CellCept®): Update on the use of medicinal products containing mycophenolate during pregnancy after paternal exposure
Active substance: Mycophenolat
The BfArM is issuing further information as a follow-up to the reinforced warning of 26 October 2015 regarding the use of mycophenolate (mycophenolate mofetil or mycophenolic acid) during pregnancy.
|
28.01.2016
|
Protopic® – Herpes-simplex eye infections
Active substance: Tacrolimus (topische Anwendung)
The BfArM points out that herpes simplex infections of the eye have been included as a new adverse reaction in the product information of Protopic®.
|
19.05.2016
|
Carbomedac®: BfArM's recommendation to filter the medicinal product is cancelled
Active substance: Carboplatin
The company Medac Gesellschaft für klinische Spezialpräparate mbH has submitted documents to the BfArM proving that filtering the medicinal product Carbomedac® prior to use as recommended until now by the BfArM is no longer necessary.
|
10.06.2016
|
Cialis®: Counterfeit medicinal products discovered in Greece
Active substance: tadalafil
The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to cases of counterfeits from Greece of Cialis 20 mg film-coated tablets for treatment of erectile dysfunction. This concerns packages with the lot numbers C334146 and C543049 on the outer package and the lot numbers A05673 and A05668 on the inner package.
|
14.07.2016
|
Acitretin and teratogenicity: Extension of the period of pregnancy prevention to 3 years after end of treatment
Active substance: Acitretin
The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and must therefore be extended to 3 years.
|