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818 results

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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 PDF, 296KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Risk information

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.

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 PDF, 157KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Information letter on Carmubris powder and solvent for solution for infusion: incorrect labeling PDF, 443KB, File does not meet accessibility standards Date: 23. May 2024 Topics: Pharmakovigilanz Type: Risk information

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

Medicinal products containing hydroxyprogesterone: safety review Date: 22. May 2024 Topics: Pharmakovigilanz Type: Risk information

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).

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) PDF, 274KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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).

Direct Healthcare Professional Communication (DHPC) on oral retinoids (acitretin, alitretinoin and lsotretinoin): Reminder of existing restrictions to prevent exposure during pregnancy PDF, 383KB, File is accessible Date: 02. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint PDF, 112KB, File does not meet accessibility standards Date: 19. April 2024 Topics: Pharmakovigilanz Type: Risk information

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 …

Pseudoephedrine: risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Date: 04. April 2024 Topics: Pharmakovigilanz Type: Risk information

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.

Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India Date: 25. March 2024 Topics: Pharmakovigilanz Type: Risk information

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) …

Direct Healthcare Professional Communication (DHPC) on Paxlovid (nirmatrelvir, ritonavir): drug interactions with certain immunosuppressants, including tacrolimus PDF, 371KB, File is accessible Date: 21. March 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.