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®.
|
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.
|
11.07.2013
|
Medicinal products containing codeine for treatment of pain in children: Key messages from the PRAC for consideration
Active substance: codeine
At its June meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) issued a document with key messages that should be considered when using medicinal products containing codeine for pain relief in children.
|
30.04.2019
|
Lapatinib (Tyverb®): Re-analysis of data on use following treatment with trastuzumab
Active substance: lapatinib
The European Medicines Agency (EMA) is updating the prescribing information for Tyverb® (lapatinib) after irregularities had been observed in results of a study involving postmenopausal women.
|
12.02.2015
|
Information on theft of the medicinal product Sildaristo® produced by Aristo Pharma GmbH in Berlin
Active substance: sildenafil
The State Office of Health and Social Affairs in Berlin ("Landesamt für Gesundheit und Soziales", LaGeSo) has informed the BfArM of the theft of the medicinal product Sildaristo®.
|
15.09.2014
|
Information on medicinal products traded illegally in Romania on the German market
Active substance: rituximab, trastuzumab
The Romanian medicines licensing authority (ANMDM) has informed the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) via the European Rapid Alert System that batches of 45 medicinal products traded by the Romanian wholesale distributor Chemomed are being recalled.
|
01.04.2020
|
Increased ring fractures with vaginal rings
Active substance: ethinylestradiol/etonogestrel
The BfArM has received a large number of reports of breaks in the vaginal rings GinoRing® (Exeltis Germany GmbH), Cyclelle® (Hexal AG), VeriAristo® (Aristo Pharma GmbH) and Setlona® (Mylan Germany GmbH), which are used for hormonal contraception. These reports indicate a quality defect.
|
25.11.2013
|
Iclusig®: Risk of blood clots
Active substance: ponatinib
The Committee for Medicinal Products for Human Use (CHMP) recommends updating the product information of the leukaemia medicine Iclusig® (ponatinib) to include new warnings in order to minimise the risk of a higher rate of blood clots.
|
29.04.2020
|
Hydroxychloroquine: risk of serious side effects when used to treat COVID-19
Active substance: hydroxychloroquine, chloroquine
The BfArM informs about the risk of serious side effects when using hydroxychloroquine for the treatment of COVID-19.
|
02.06.2020
|
Hydroxychloroquine: renewed warning of risks when used to treat COVID-19
Active substance: hydroxychloroquine, chloroquine
The European Medicines Agency (EMA) again warns about the risks of using hydroxychloroquine (and chloroquine) to treat COVID-19.
|
27.11.2020
|
Hydroxychloroquine and Chloroquine: psychiatric disorders
Active substance: hydroxychloroquine, chloroquine
Current information about psychiatric disorders for Chloroquine and Hydroxychloroquine.
|
15.05.2020
|
Hormone replacement therapy: PRAC completes review of new information on known breast cancer risk
Active substance: substances for hormone replacement therapy
The Committee for Pharmacovigilance Risk Assessment (PRAC) of the EMA recommends updating the current safety information of medicinal products for HRT, in relation to the known increased risk of breast cancer.
|
24.11.2011
|
GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned
Active substance: busulfan, doxorubicin, bortezomib, azacitidine
Due to considerable shortcomings in adhering to Good Manufacturing Practice (GMP) at the Ben Venue Laboratories in the USA, the manufacturer of the active substance, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) assessed and in part recalled the centrally authorised medicinal products Busilvex®, Caelyx®, Velcade® and Vidaza®.
|
26.07.2019
|
Gilenya® (Fingolimod): Updated restrictions for use during pregnancy
Active substance: fingolimod
The European Medicines Agency (EMA) has recommended that the multiple sclerosis drug Gilenya® (fingolimod) should not be used in pregnant women and women of childbearing potential who do not use effective contraception.
|
23.03.2018
|
Fiasp®: Colour change for insulin injection Fiasp® to avoid mix-ups with Tresiba®
Active substance: insulin aspart
The colour of cartridges of the pre-filled pens and vials of the rapid-acting insulin Fiasp® is changing from yellow to red and yellow, as there have been reports of cases where patients mistakenly injected Fiasp® instead of the long-acting insulin Tresiba® (available in the EU as light green cartridges and pens) or the other way around.
|