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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17.06.2014
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Sutent® 25 mg and 50 mg hard capsules: BfArM issues warning regarding counterfeits of the medicinal product from Romania
Active substance: sunitinib
The Federal Institute for Medicinal Products and Medical Devices (BfArM) is circulating a warning against counterfeits of the 25 mg and 50 mg strengths of the cancer drug Sutent® produced by Pfizer. The counterfeits that are parallel imported can be identified based on visible differences in hard capsules and foil sealing of the plastic bottle.
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04.11.2010
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Tamoxifen: Interaction with CYP2D6 inhibitors
Active substance: tamoxifen
Concomitant administration of tamoxifen and strong inhibitors of the cytochrome P450 2D6 enzyme (CYP2D6) should be avoided, as a resulting reduced efficacy of tamoxifen cannot be excluded.
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18.03.2010
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Tamoxifen: Interaction with SSRIs (selective serotonin reuptake inhibitors)
Active substance: tamoxifen
A Canadian cohort study showed that the SSRI, paroxetin, may decrease the effect of tamoxifen in a hormone therapy of mamma carcinoma (BMJ 2010; 340:c693). Concomitant administration of tamoxifen and paroxetin was found to increase breast cancer mortality.
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07.11.2014
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Tecfidera® (dimethyl fumarate): First case of progressive multifocal leukoencephalopathy (PML)
Active substance: dimethyl fumarate
At the request of the BfArM, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera® (dimethyl fumarate) at its meeting from 3 - 6 November 2014.
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14.12.2010
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Thelin® (sitaxentan): intended withdrawal from the market
Active substance: sitaxentan
The pharmaceutical company Pfizer has informed the BfArM that it intends to withdraw Thelin® (sitaxentan) from the market.
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25.10.2012
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Tolperisone: Restriction of indication
Active substance: tolperisone
Due to the insufficiently demonstrated efficacy in some indications from the range of painful muscular tension and in view of the risk of allergic reactions, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends a restriction of the indications to post-stroke spasticity in adults.
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22.03.2011
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Topiramate: Data concerning the risk of malformations
Active substance: topiramate
Based on evaluations from pregnancy registries, the USA has now also revised the product informations of medicinal products containing topiramate and has included corresponding warnings already implemented in European marketing authorisations.
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09.02.2012
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Ukrain: New findings with regard to detrimental effects of the medicinal product
Active substance:
In the course of recent findings, the BfArM has extended its assessment of the medicinal product Ukrain and now classifies Ukrain as an unsafe medicinal product.
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16.08.2023
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Valproate: Evaluation of data on paternal exposure by the PRAC
Active substance: Valproat
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.
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12.01.2024
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Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
Active substance: valproate
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends precautionary measures for the treatment of male patients with valproate-containing medicinal products.
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26.01.2024
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Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
Active substance: valproate
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines.
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02.07.2015
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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.
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20.07.2016
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Viread 245 mg and Truvada 200 mg: Counterfeit medicinal products discovered
Active substance: tenofovi rdisoproxil, emtricitabine
The Federal Institute for Drugs and Medical Devices (BfArM) warns that counterfeits of the medicinal products Viread 245 mg film-coated tablets and Trudava 200 mg film-coated tablets have been discovered in several European countries.
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10.04.2015
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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.
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