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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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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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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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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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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