Active substance: phenytoin sodium

The company Desitin Arzneimittel GmbH informs about a possible quality defect of the medicinal product Phenhydan solution for injection.

Active substance: voxelotor

EMA confirms suspension of sickle cell disease medicine Oxbryta

Active substance: caspofungin

The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.

Active substance: finasteride, dutasteride

The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.

Active substance: isoniazid

Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution.

Active substance: clozapine

The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.

Active substance: soya bean oil, refined, medium-chain triglycerides, omega-3-acid triglycerides

Braun Melsungen AG informs about agglomerates consisting of droplet-like structures that have been detected in individual batches of the medicinal product.

Active substance: risdiplam

The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 3

Active substance: ruxolitinib phosphate

The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.

Active substance: nitrous oxide, oxygen

The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O₂/N₂O breathing systems.

Active substance: aztreonam, avibactam

The company Pfizer Europe MA EEIG informs about the risk of broken or cracked glass vials of  Emblaveo 1.5 g/0.5 g  powder for concentrate for solution for infusion.

Active substance: fezolinetant

The marketing authorisation holder of Veoza (fezolinetant) would like to inform about the risk of drug-induced liver injury.

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.

Active substance: obeticholic acid

On 26 November 2024, the General Court dismissed the action for interim measures, which means that the revocation decision for Ocaliva has now taken effect.

Active substance: hydroxycobalamin

The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.

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 …

Active substance: medroxyprogesterone acetate

The marketing authorisation holder of medroxyprogesterone acetate-containing medicines would like to inform you about the increased risk of developing meningioma with high doses of medroxyprogesterone acetate.

Active substance: voxelotor

Pfizer Europe would like to inform you that the marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks is ongoing.

Active substance: glatiramer acetate

The marketing authorisation holders of glatiramer acetate-containing medicinal products provide information about anaphylactic reactions that can occur shortly after the administration of glatiramer acetate, even months to years after the start of …

Active substance: amidotrizoic acid

The company Dr. Franz Köhler Chemie GmbH informs that during the ongoing stability program visible particles have been found in the medicinal products Peritrast 180/31%, Peritrast Infusio 31% (retro) and Peritrast 300/60%.

Active substance: obeticholic acid

The marketing authorisation holders of medicinal products containing obeticholic acid inform about the revocation of the marketing authorisation because the clinical benefit has not been confirmed in patients with primary biliary cholangitis.

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.

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.

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).

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.

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.

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.

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.