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16 results

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Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: Important measures to minimise the serious outcomes of known risk of agranulocytosis PDF, 234KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

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

Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches PDF, 214KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxycobalamin

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

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.): In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution. PDF, 338KB, File does not meet accessibility standards Date: 24. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …

Direct Healthcare Professional Communication (DHPC) on medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk PDF, 405KB, File does not meet accessibility standards Date: 09. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on Oxbryta (voxelotor): Suspension of EU marketing authorisation PDF, 454KB, File is accessible Date: 07. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on glatiramer acetate: Anaphylactic reactions may occur months up to years after treatment initiation PDF, 360KB, File is accessible Date: 19. August 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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 …

Update of Direct Healthcare Professional Communication (DHPC) on Peritrast 180/31%, Peritrast Infusio 31 % (retro) and Peritrast 300/60% solutions for injection: Risk due to visible particles PDF, 144KB, File does not meet accessibility standards Date: 16. August 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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%.

Direct Healthcare Professional Communication (DHPC) on Ocaliva (obeticholic acid): Recommendation for revocation of the marketing authorisation in the European Union due to unconfirmed clinical benefit PDF, 385KB, File is accessible Date: 01. August 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Update of the Direct Healthcare Professional Communication (DHPC) on L-Arginine-Hydrochloride 21 % Braun (5 x 20 ml ampoules): Risk due to visible particles PDF, 143KB, File does not meet accessibility standards Date: 11. July 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

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.