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819 results

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Direct Healthcare Professional Communication (Rote-Hand-Brief) on Natpar 100 micrograms/dose powder and solvent for solution for injection of the company Takeda: Expected supply shortage from July 1st, 2022 PDF, 212KB, File is accessible Date: 09. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Parathyroid hormone

Takeda informs of an expected supply shortage for the medicinal product Natpar 100 micrograms/dose strength due to manufacturing challenges.

Direct Healthcare Professional Communication (DHPC) on Rubraca®▼(rucaparib-camsylate): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care PDF, 261KB, File is accessible Date: 06. May 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: rucaparib-camsylate

The interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care.

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Accupro of the company Pfizer: Recall due to nitrosamine contamination PDF, 70KB, File is accessible Date: 28. April 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Quinapril hydrochloride

Pfizer informs about a precautionary recall of all strengths and pack sizes of the medicinal product Accupro at pharmacy level, as investigations have identified nitrosamine contamination.

Direct Healthcare Professional Communication (Rote-Hand-Brief) on Accuzide of the company Pfizer: Recall due to nitrosamine contamination PDF, 99KB, File is accessible Date: 28. March 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Quinapril hydrochloride, hydrochlorothiazide

Pfizer informs about a precautionary recall of all strengths and package sizes of the medicinal product Accuzide at pharmacy level, as nitrosamine contamination has been detected by investigations.

Dihydroergotamine and dihydroergotoxine: unfavourable risk-benefit ratio Date: 11. March 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dihydroergotamine | dihydroergotoxine

In a notice dated 15. January 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2020

Direct Healthcare Professional Communication (DHPC) on Xagrid® (anagrelide hydrochloride): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation PDF, 81KB, File is accessible Date: 22. February 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anagrelide hydrochloride

Shire Pharmaceuticals Ireland Limited (a subsidiary of Takeda Pharmaceuticals Company Limited) would like to inform you that there is an increased risk of thrombotic complications, including cerebral infarction, upon abrupt anagrelide discontinuation.

Direct Healthcare Professional Communication (DHPC) on Mavenclad (cladribine): risk of serious liver injury and new recommendations about liver function monitoring PDF, 145KB, File is accessible Date: 16. February 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cladribine

Merck Healthcare Germany GmbH provides information about liver damage, including serious cases, reported during treatment of patients with Mavenclad®.

Direct Healthcare Professional Communication (DHPC) on Berlthyrox® (levothyroxine sodium): new composition and new trade name L-Thyroxine BC® - Information and control of patients during the changeover PDF, 2MB, File is accessible Date: 10. January 2022 Topics: Aktuelles Pharmakovigilanz Type: Direct Healthcare Professional Communication

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.

Direct Healthcare Professional Communication (DHPC) on irinotecan-containing drugs: Drug toxicity in patients with reduced UGT1A1 activity PDF, 471KB, File is accessible Date: 21. December 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: irinotecan hydrochloride 3 H2O

Marketing authorization holders of irinotecan-containing drugs inform that UGT1A1 genotyping may be helpful to avoid the risk of neutropenia and diarrhea.

Contact persons for Pharmacovigilance Date: 29. November 2021 Topics: Pharmakovigilanz Type: Article

Contact persons for Pharmacovigilance