16.02.2024
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Contrast agents containing gadolinium: deposits in the brain and other tissues
Active substance: gadolinium
For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.
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04.04.2024
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Direct Healthcare Professional Communication (DHPC) on Atropinsulfat 100 mg solution for injection: Risk of visible particles in the solution, use of a filter
Active substance: Atropine sulfate
The company Dr. Franz Köhler Chemie GmbH informs about particle detected during the ongoing stability studies in the medicinal product Atropinsulfat 100 mg solution for injection, 5 x 10 ml and 25 x 10 ml.
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23.02.2024
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Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism
Active substance: chlormadinone acetate, ethinyl estradiol
The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.
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27.05.2024
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Direct Healthcare Professional Communication (DHPC) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution: potentially low fill vials and important information regarding instructions for use
Active substance: angiotensin II
The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.
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08.05.2024
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Direct Healthcare Professional Communication (DHPC) on Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage (number of drops per millilitre)
Active substance: sodium perchlorate
Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage a different dosage (number of drops per millilitre).
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02.05.2024
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Direct Healthcare Professional Communication (DHPC) on oral retinoids (acitretin, alitretinoin and lsotretinoin): Reminder of existing restrictions to prevent exposure during pregnancy
Active substance: acitretin, alitretinoin, isotretinoin
The marketing authorisation holders of acitretin-, alitretinoin- and isotretinoin-containing medicinal products remind you of the pregnancy prevention program for oral retinoids.
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21.03.2024
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Direct Healthcare Professional Communication (DHPC) on Paxlovid (nirmatrelvir, ritonavir): drug interactions with certain immunosuppressants, including tacrolimus
Active substance: nirmatrelvir, ritonavir
Pfizer reminds of already known drug interactions of paxlovid with certain immunosuppressants, including tacrolimus, with potentially life-threatening and fatal consequences.
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15.02.2024
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Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome
Active substance: pseudoephedrine
Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.
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19.02.2024
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Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate
Active substance: valproate
The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.
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19.04.2024
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Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint
Active substance: tipranavir
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs that batch 308715 of the medicinal product Aptivus 250 mg soft capsules (120 capsules per bottle) may contain capsules with only a faint imprint “TPV 250” or without this imprint at all.
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23.05.2024
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Information letter on Carmubris powder and solvent for solution for infusion: incorrect labeling
Active substance: carmustine
The company TILLOMED PHARMA GmbH informs about an incorrect labeling of three batches of the medicinal product Carmubris powder and solvent for solution for infusion
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01.03.2024
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Information Letter on Spiolto Respimat: Possibly defective dose indicator
Active substance: tiotropium bromide/olodaterol hydrochloride
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.
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02.07.2024
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Medicinal products containing hydroxyprogesterone: safety review
Active substance: hydroxyprogesterone
Hydroxyprogesterone caproate medicines to be suspended from the EU market.
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14.06.2024
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Metamizole-containing medicinal products: risk of agranulocytosis - referral
Active substance: metamizole
EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.
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04.04.2024
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Pseudoephedrine: risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
Active substance: pseudoephedrine
With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.
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15.07.2024
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Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India
Active substance: various
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission of 24 May 2024 for the German marketing authorisations with its decision of 17 June 2024.
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27.05.2024
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Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter
Active substance: disodium folinate
The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.
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11.07.2024
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Update of the Direct Healthcare Professional Communication (DHPC) on L-Arginine-Hydrochloride 21 % Braun (5 x 20 ml ampoules): Risk due to visible particles
Active substance: L-arginine hydrochloride
The company B. Braun Melsungen AG informs that visible particles have been found in the retained samples of several batches of the medicinal product L-Arginine Hydrochloride 21 % Braun.
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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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