18.06.2019
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Faecal microbiota transplantation (FMT, stool transplantation): Risk of transmission of multi-resistant bacteria
Active substance: FMT
The American Food and Drug Administration (FDA) warns of the risk of serious bacterial infections caused by the transmission of multi-resistant bacteria during faecal microbiota transplants (FMT).
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30.04.2019
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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.
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20.03.2019
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Xeljanz® (tofacitinib): Increased risk of blood clots in lungs and death with higher dose for rheumatoid arthritis
Active substance: tofacitinib
EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz® (tofacitinib) when treating rheumatoid arthritis.
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20.11.2018
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Risk information for Colchicum-Dispert® and Colchysat®Bürger by the company Bürger
Active substance: Colchicin
Based on reports of overdosage leading to death, the dosing recommendations and warnings have been updated.
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15.11.2018
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Suicidal tendencies possibly linked to depression associated with use of hormonal contraception
Active substance: hormonal contraceptives
As a result of a signal procedure on the risk of suicidal tendencies in connection with the use of hormonal contraceptives, a new warning is to be included in the Summary of Product Characteristics and Patient Information Leaflet.
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22.05.2018
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Dolutegravir (Tivicay®, Triumeq®): New study suggests risk of birth defects in babies born to women who were treated for HIV infection
Active substance: dolutegravir
The European Medicines Agency (EMA) is currently evaluating preliminary results from a study which found 4 cases of birth defects.
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12.04.2018
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Benzodiazepines/benzodiazepine like products and opioids: Concomitant use
Active substances: benzodiazepines | opioids
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) recommends texts for the product informations of benzodiazepines/benzodiazepine like products and opioids.
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23.03.2018
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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.
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21.12.2017
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Mycophenolate: Updated recommendations on contraceptive measures for women and men
Active substance: mycophenolate
The European Medicines Agency (EMA) has updated its recommendations on contraceptive measures for women and men taking medicinal products that contain mycophenolate.
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14.08.2017
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Counterfeits of the medicinal product VELCADE® 3.5 mg powder for solution for injection discovered in Germany
Active substance: bortezomib
The Federal Institute for Drugs and Medical Devices (BfArM) is issuing information on counterfeits of the medicinal product VELCADE 3.5 mg powder for solution for injection by Janssen-Cilag International NV, Belgium which were was found in Germany at the parallel distributor EuroPharma hvd medical GmbH in the Saarland.
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02.08.2017
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Counterfeits of the medicinal product Xeplion® 150 mg extended-release suspension for injection (batches GFB4D00_BG-RO and GEB3Z00_BG-RO) have reached the German market (including amendments of 2 August 2017, 28 July 2017 and 26 July 2017)
Active substance: paliperidon
The Federal Institute for Drugs and Medical Devices (BfArM) has received new information on a further batch concerned in the case of counterfeits of the medicinal product Xeplion 150 mg extended-release suspension for injection (active substance: paliperidone) by Janssen-Cilag. The presentation of this batch is likewise Romanian/Bulgarian.
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18.07.2017
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Omnitrope® 15 mg / 1.5 ml solution for injection (somatropin) Batch EL9738: Counterfeit being offered in German packaging
Active substance: somatropin
The Federal Institute for Drugs and Medical Devices (BfArM) refers to counterfeits of the medicinal product Omnitrope® 15 mg / 1.5 ml solution for injection by the company Sandoz reported in France, Denmark and Mexico. The medicinal product normally contains the active substance somatropin and is a growth hormone used for the treatment of growth hormone deficiency.
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18.05.2017
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Epclusa® 400 mg/100 mg film-coated tablets (batch 15SFPD119): Counterfeit in German packaging offered to wholesaler
Active substance: sofosbuvir, velpatasvir
The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.
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28.12.2016
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Norditropin® SimpleXx® 15 mg/1,5 ml (Badge DC80754): Counterfeit in the illegal distribution chain
Active substance: somatropin
The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the medicinal product Norditropin® SimpleXx® 15 mg/1,5 ml solution for injection by the company Novo Nordisk has been discovered in the illegal distribution chain in Germany.
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20.12.2016
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Recall of the medicinal product Tranexamsäure Carino 100 mg/ml, 5 ml ampoules, 5x5 ml solution for injection, PZN 10816978 batch designation: 013024 due to mix-up with Urapidil-25 mg-Carino ampoules
Active substance: tranexamic acid
The Federal Institute for Drugs and Medical Devices (BfArM) calls attention to the recall of batch 013024 of the medicinal product Tranexamsäure Carino 100 mg/ml by the company Carinopharm GmbH.
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