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PSUR Repository Date: 04. March 2020 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

The PSUR Repository is a central database at the European Medicines Agency (EMA) for the submission, archiving and management of all periodic safety update reports (PSURs) and the associated process documents (assessment reports, response documents, …

Information Letter on valproate: restrictions on use and introduction of the contraceptive programme PDF, 821KB, File is accessible Date: 26. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders Aristo Pharma GmbH, Desitin Arzneimittel GmbH and Sanofi-Aventis Deutschland GmbH will again provide information about restrictions on use and the introduction of the pregnancy prevention programme for …

Direct Healthcare Professional Communication (DHPC) on Linoladiol N® (Estradiol): risks associated with systemic exposure PDF, 701KB, File is accessible Date: 20. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: estradiol

Dr. August Wolff GmbH & Co. KG Arzneimittel in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that treatment with Linoladiol N® (containing estradiol 100 …

Direct Healthcare Professional Communication (DHPC) on▼Picato® (ingenol mebutate): suspension of the marketing authorisation due to risk of skin malignancy PDF, 116KB, File does not meet accessibility standards Date: 27. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ingenol mebutate

LEO Pharma would like to inform you about the suspension of the marketing authorisation of Picato (ingenol mebutate) as a precautionary measure due to growing concerns on the possible risk of skin malignancy.

Direct Healthcare Professional Communication (DHPC) on Implanon NXT® - Etonogestrel 68 mg for subcutaneous use: updated instructions for inserting and removing the implant PDF, 188KB, File is accessible Date: 15. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

In consultation with the Federal Institute for Drugs and Medical Devices (BfArM), MSD Sharp & Dohme GmbH informs that the instructions for inserting and removing the implant have been updated to further minimize the risk of neurovascular …

Medicinal products containing kava-kava: risk of severe hepatic injury, alterations of the marketing authorisations concerned Date: 23. December 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: kava-kava

The Cologne Administrative Court issues a ruling regarding the legality of the decision in the national graduated plan procedure ("Stufenplanverfahren").

Dear Doctor Letter (Rote-Hand-Brief) on ▼Increlex® (Mecasermin): risk of benign and malignant neoplasia PDF, 173KB, File is accessible Date: 02. December 2019 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mecasermin

Ipsen Pharma provides information on cases of benign and malignant neoplasia in children and adolescents treated with Increlex® after the launch of Mecasermin.

Pharmacovigilance Date: 26. November 2019 Topics: Pharmakovigilanz Type: Article

Pharmacovigilance

FAQ "Pharmacovigilance" Date: 26. November 2019 Topics: Pharmakovigilanz Type: Article

FAQ "Pharmacovigilance"

Methotrexate: dosing errors Date: 25. November 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methotrexate

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2019) 7680 final of 21 October 2019 by decision of 20 November 2019.