BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Cyproterone-containing medicines: review of meningioma risk Date: 19. May 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone

The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 25 March 2020.

Hormone replacement therapy: PRAC completes review of new information on known breast cancer risk Date: 15. May 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: substances for hormone replacement therapy

The Committee for Pharmacovigilance Risk Assessment (PRAC) of the EMA recommends updating the current safety information of medicinal products for HRT, in relation to the known increased risk of breast cancer.

Information Letter on Anticholium® (physostigmine salicylate): change in the approval PDF, 158KB, File is accessible Date: 14. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: physostigmine salicylate

Dr. Franz Köhler Chemie GmbH informs about the change in the approval of Anticholium®. The intramuscular application is no longer approved. Anticholium® is now sodium metabisulfite free.

Direct Healthcare Professional Communication (DHPC) on brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine PDF, 572KB, File is accessible Date: 12. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Marketing authorisation holders of medicines containing brivudine inform that deaths may occur as a result of interaction between brivudine and fluoropyrimidines.

Picato® (ingenol mebutate): evaluation of the benefit-risk ratio Date: 05. May 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ingenol mebutate

The Committee for Medicinal Products for Human Use (CHMP) has adopted the PRAC recommendation.

Hydroxychloroquine: risk of serious side effects when used to treat COVID-19 Date: 29. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The BfArM informs about the risk of serious side effects when using hydroxychloroquine for the treatment of COVID-19.

Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German) PDF, 258KB, File does not meet accessibility standards Date: 27. April 2020 Topics: Pharmakovigilanz Type: Download

Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German)

Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma PDF, 723KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Cyproteronacetat

The marketing authorisation holders of cyproterone containing medicines would like to inform about the occurrence of meningiomas in association with the use of cyproterone acetate.

Information Letter on Zomacton® (somatropin): change in the trade names of the injection equipment for administering the drugs PDF, 192KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

Ferring Arzneimittel GmbH informs that the needle-free injection device ZomaJet 2 Vision for the administration of Zomacton® 4 mg has been renamed ZomaJet 4 and the needle-free injection device ZomaJet Vision X for the administration of …

High-dose creams containing estradiol: a new risk review Date: 08. April 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

With its notice within the graduated plan procedure of 18 March 2020, the BfArM implements the unanimous decision of the coordination group, CMDh.

Increased ring fractures with vaginal rings Date: 01. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: ethinylestradiol/etonogestrel

The BfArM has received a large number of reports of breaks in the vaginal rings GinoRing® (Exeltis Germany GmbH), Cyclelle® (Hexal AG), VeriAristo® (Aristo Pharma GmbH) and Setlona® (Mylan Germany GmbH), which are used for hormonal …

Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial PDF, 239KB, File is accessible Date: 31. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenic trioxide

The company Teva B.B. informs in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the Trisenox® (arsenic trioxide) 1 mg/ml 10 ml ampoule (contains 10 mg arsenic …

Direct oral anticoagulants (apixaban, dabigatran etexilate, rivaroxaban): no application changes required Date: 30. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: apixaban | dabigatran etexilate | rivaroxaban

Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) …

Xeljanz® (tofacitinib): increased risk of venous thromboembolic events and of serious and fatal infections Date: 23. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tofacitinib

With the publication of the European Commission's decision, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 for Xeljanz® was completed.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg for uterine fibroids: not to be used during ongoing review of liver injury risk PDF, 255KB, File is accessible Date: 23. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

Gedeon Richter Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that Ulipristal acetate 5 mg is temporarily withdrawn from the market during the ongoing …

Direct Healthcare Professional Communication (DHPC) on Xeljanz® (Tofacitinib): increased risk of venous thromboembolic events and increased risk of serious and fatal infections PDF, 337KB, File is accessible Date: 20. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), informs that a dose-dependent increased risk of serious venous thromboembolic events has been observed in …

DHPCs (Rote-Hand-Briefe) and Information Letters Date: 19. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Here you will find Direct Healthcare Professional Communications - DHPCs (so-called "Rote-Hand-Briefe") and Information Letters sent out by pharmaceutical companies informing healthcare professionals about newly identified major drug-associated risks …

Calcitonin: restricted use Date: 19. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Calcitonin

With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.

Direct Healthcare Professional Communication (DHPC) on Cytotec® (misoprostol): risks associated with an off-label use for birth initiation PDF, 235KB, File is accessible Date: 16. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Misoprostol

The German Federal Institute for Drugs and Medical Devices (BfArM) informs that there are numerous new reports of severe side effects when using Cytotec® outside the approved indication. The drug Cytotec® is not approved for birth initiation.

Expert Advisory Committee for Pharmacy-Only Issues Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Pharmacy-Only Issues (in accordance with section 53 German Medicines Act) take place as and when required.

Routine sessions pursuant to Section 63 German Medicines Act (AMG) Date: 06. March 2020 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Routine sessions pursuant to Section 63 AMG take place at the BfArM at least twice a year, where graduated plan stakeholders (Stufenplanbeteiligte) exchange information about current problems of pharmaceutical safety.

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"