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443 results

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Dear Doctor Letter (Rote-Hand-Brief) on Adempas® (riociguat): New contraindication for patients with pulmonary hypertension in connection with idiopathic interstitial pneumonia (PH-IIP) PDF, 900KB, File is accessible Date: 05. July 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: riociguat

In coordination with the European Medicines Agency the companies Bayer and MSD are circulating a Dear Doctor Letter on Adempas® with information regarding preliminary results of the RISE-IIP study.

Implanon NXT®: Possible risks and complications associated with insertion, localisation, removal and migration PDF, 1MB, File does not meet accessibility standards Date: 27. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

The company MSD Sharp & Dohme GmbH recommends that only those physicians should insert and remove Implanon NXT® who have completed training for the use of the NXT® applicator and techniques for insertion and removal of the Implanon NXT® …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene®: New important information on virus reactivation and pulmonary hypertension PDF, 504KB, File is accessible Date: 21. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The company Celgene GmbH is circulating information on cases of virus reactivation and pulmonary hypertension under treatment with thalidomide.

Renewed Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Shortage and instructions for use for the additional batch 177G* PDF, 400KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 177G* imported from the United Kingdom.

Information Letter on Erwinase® 10,000 IU/vial (crisantaspase): Instructions for use and shortage PDF, 139KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: crisantaspase

The company Jazz Pharmaceuticals Germany GmbH is circulating information on use and handling instructions (visual inspection and filtering) of the Erwinase batch 174G imported from the United Kingdom.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing fusafungine (Locabiosol®): revocation of marketing authorisation PDF, 262KB, File is accessible Date: 22. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fusafungine

By way of a Dear Doctor Letter, the company concerned is informing healthcare professionals of the revocation of the marketing authorisations of medicinal products containing fusafungine (Locabiosol® as mouth and nose spray) within the EU.

Dear Doctor Letter (Rote-Hand-Brief) on BCR-ABL tyrosine kinase inhibitors: Risk of reactivation of hepatitis B PDF, 339KB, File is accessible Date: 08. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: imatinib, dasatinib, nilotinib, bosutinib, ponatinib

The pharmaceutical companies concerned are circulating information on the risk of reactivation of hepatitis B after treatment with BCR-ABL tyrosine kinase inhibitors and the necessity of examining patients with regard to hepatitis B viral load …

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (idelalisib): Restrictions of use PDF, 319KB, File is accessible Date: 24. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on interim recommendations on restrictions of use of Zydelig.

Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw PDF, 1MB, File does not meet accessibility standards Date: 17. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

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Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material PDF, 167KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223 dichloride

The company Bayer Vital GmbH is circulating information that the National Institute of Standards and Technology (NIST) has recently revised the primary standardisation for Radium-223.