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.

Active substance: chlormadinone, nomegestrol The marketing authorisation holders of chlormadinone- and nomegestrol- containing medicines would like to inform you that medicinal products containing chlormadinone acetate or nomegestrol acetate are only indicated when other interventions are considered inappropriate.

Active substance: varenicline The company Pfizer Pharma GmbH informs that all Champix (varenicline) batches that were found to contain N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.

Active substance: Varenicline The company Pfizer would like to inform that several batches of the drug CHAMPIX are being recalled

Active substance: vandetanib Sanofi informs that data from a randomized trial and an observational study show insufficient efficacy of vandetanib in patients without identified RET mutations.

Active substance: cabazitaxel Accord Healthcare S.L.U., Spain, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), would like to inform about the risk for the occurrence of medication errors due to different cabazitaxel products available on the market.

Active substance: brivudine Marketing authorisation holders of medicines containing brivudine inform that deaths may occur as a result of interaction between brivudine and fluoropyrimidines.

Active substance: levothyroxine sodium From mid-January 2022, a new formulation of Berlthyrox® will be available under the new trade name L-Thyroxine BC® and with a new package design.

Active substance: azacitidine The marketing authorization holders of Azacitidin 25 mg/ml would like to inform in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) of the new 150 mg azacitidine presentation on the market and the potential risk of medication errors.

Active substance: amiodarone The company Hameln Pharma GmbH would like to inform that there is an increased potential for crystallization in ampoules.

Active substance: amfepramone Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.

Active substance: hydrocortisone Diurnal Europe B.V. informs about the report of an adrenal crisis in an infant who was switched from soluble hydrocortisone tablets to Alkindi®.

Active substance: 5-Fluorouracil The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be interpreted with caution as there is an increased risk of misdiagnosis of DPD deficiency, which may lead to underdosing of 5-fluorouracil and thus reduced treatment efficacy.

Active substance: 5-fluorouracil, capecitabine, tegafur The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an increased risk of severe toxicity during treatment with fluoropyrimidines (5-FU i.v., capecitabine, tegafur)

Active substance: tofacitinib Pfizer Europe MA EEIG provides information about an increased incidence of myocardial infarction with tofacitinib compared with TNF-alpha inhibitors, as well as an increased incidence of malignancy in patients with rheumatoid arthritis (RA) who were 50 years of age or older and had at least one additional cardiovascular risk factor.