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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14.12.2023
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Direct Healthcare Professional Communication (DHPC) on etoposide (not etoposide phosphate): hypersensitivity reactions with the use of inline filters
Active substance: etoposide
The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.
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12.12.2023
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Direct Healthcare Professional Communication (DHPC) on Furosemid-hameln 10 mg/ml (250 mg in 25 ml; 10 x 25 ml ampoules; PZN 16833989): visible particles
Active substance: furosemide
Furosemide-hameln ampoules may contain isolated visible particles. The batches mentioned should be checked visually before use.
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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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14.12.2023
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Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis
Active substance: miltefosine
The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.
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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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21.12.2023
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Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection
Active substance: Inclisiran
The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.
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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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22.05.2024
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Medicinal products containing hydroxyprogesterone: safety review
Active substance: hydroxyprogesterone
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).
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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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25.03.2024
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Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India
Active substance: various
On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Pune, India.
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