BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

818 results

Results per page: 10 20 30

Mysimba: potential long-term cardiovascular risk Date: 15. September 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: naltrexone, bupropion

EMA has started a review of Mysimba (naltrexone/bupropion), a medicine for weight management in adults who have obesity or are overweight.

Direct Healthcare Professional Communication (DHPC) on fentanyl-containing transdermal patches: late inclusion of a warning on accidental use PDF, 426KB, File is accessible Date: 01. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

Marketing authorization holders of fentanyl-containing transdermal patches provide information on the delayed inclusion of an accidental use warning on the outer packaging and, if applicable, the patches sachets.

Information Letter on Zeposia (Ozanimod): Modified dosing recommendation for mild or moderate chronic hepatic impairment (Child-Pugh class A or B) PDF, 134KB, File is accessible Date: 18. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ozanimod

Bristol Myers Squibb provides information on the recommendation for dose reduction in mild or moderate chronic hepatic impairment.

The restrictions on the use of mitomycin preparations from Medac GmbH for intravenous administration are lifted PDF, 484KB, File does not meet accessibility standards Date: 17. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

Medac GmbH informs about the lifting of the restrictions on the use of its mitomycin preparations for intravenous administration.

Valproate: Evaluation of data on paternal exposure by the PRAC Date: 16. August 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: Valproat

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.

Information for marketing authorisation holders: current information on submission for step 2 Date: 04. August 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 2

Direct Healthcare Professional Communication (DHPC) on Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL PDF, 243KB, File is accessible Date: 01. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vosoritide

BioMarin International Limited in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that from August 2023, Voxzogo co-packs will contain new solvent needles and …

Direct Healthcare Professional Communication (DHPC) on L-Thyroxin Aristo (levothyroxine sodium): Tablets in new composition - information and close monitoring of patients during the switch PDF, 850KB, File does not meet accessibility standards Date: 17. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxin sodium

Aristo Pharma GmbH informs about a new composition of L-thyroxine Aristo tablets, which will be available from August 2023. A close control is recommended.

Direct Healthcare Professional Communication (DHPC) on Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion of the company Medac: Recall of three batches PDF, 232KB, File does not meet accessibility standards Date: 14. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Dacarbazine

Medac Gesellschaft für klinische Spezialpräparate mbH informs about a precautionary recall of the batches G220299AH, D220154AB and D220154AF of the medicinal product Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion.

Direct Healthcare Professional Communication (DHPC) on Noxafil (posaconazole): new dosage form – risk of medication error PDF, 434KB, File does not meet accessibility standards Date: 07. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: posaconazole

Merck Sharp & Dohme B.V. provides information about the new dosage form of Noxafil and the risk of associated medication errors.

Expert Advisory Committee for Prescription-Only Issues Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Meetings of the Expert Advisory Committee for Prescription-Only Issues (in accordance with section 53 German Medicines Act) take place twice yearly (January/June).

Instructions for submission of an application for changing the legal status Date: 30. June 2023 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Instructions for submission of an application for changing the legal status

Direct Healthcare Professional Communication (DHPC) on Gavreto▼ (pralsetinib): Increased risk for tuberculosis and measures to minimize this risk PDF, 389KB, File is accessible Date: 16. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pralsetinib

Roche Pharma AG informs about the occurrence of mostly extrapulmonary tuberculosis in patients treated with Gavreto.

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolone antibiotics: reminder on restrictions of use PDF, 379KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin

The marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to remind of the recent study data which suggest that …

Direct Healthcare Professional Communication (DHPC) on Cyclophosphamid beta 500 mg/ml, 1000 mg/2 ml, 2000 mg/4 ml concentrate for solution for injection/infusion (cyclophosphamide): Contraindicated in children and adolescents due to alcohol content PDF, 120KB, File is accessible Date: 01. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyclophosphamide

betapharm Arzneimittel GmbH informs that cyclophosphamide beta concentrate for solution for injection/infusion is contraindicated for children and adolescents due to the alcohol content.

Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product PDF, 1MB, File is accessible Date: 26. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Epinephrine

The marketing authorisation holder Pharma Swiss Česká republika s.r.o. and the distributor Dr. Gerhard Mann chem.-pharm. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all …

Direct Healthcare Professional Communication (DHPC) on propofol: risk of sepsis with multiple withdrawals from one container PDF, 172KB, File is accessible Date: 16. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: propofol

The marketing authorisation holders of propofol-containing medicinal products provide information that propofol-containing medicinal products are only authorised for single use in a single patient.

Methotrexate-containing medicinal products: improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA Date: 30. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: methotrexate

The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures …

Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration PDF, 86KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: Mitomycin

Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous …

Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation Date: 17. March 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Janus kinase inhibitors

AbbVie, Galapagos, Lilly and Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the updated recommendations for risk minimisation regarding the …

Pholcodine: risk of anaphylactic reactions Date: 14. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: Pholcodine

The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European …

Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208 PDF, 347KB, File is accessible Date: 27. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Mercaptamine bitartrate

Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.

Marketing authorisations based on studies performed at the Semler Research Center (SRC) Private Ltd. company in India: suspension of marketing authorisations Date: 15. February 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: atovaquone/proguanil hydrochloride | celecoxib | eprosartan | pregabalin | saquinavir

No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India.

Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials) PDF, 132KB, File is accessible Date: 15. February 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Methotrexate

The product Methotrexat medac 25 mg/ml solution for injection (in vials) with the marketing authorisation number 80379.00.00 is only available for oncological indications.

Amfepramone: safety review Date: 08. February 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Amfepramone

Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all …

Sartans: contamination of active ingredients Date: 03. January 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valsartan | candesartan | irbesartan | losartan | olmesartan

The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.

Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication PDF, 284KB, File is accessible Date: 02. January 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vandetanib

Sanofi informs that data from a randomized trial and an observational study show insufficient efficacy of vandetanib in patients without identified RET mutations.

Terlipressin-containing medicinal products: safety review Date: 30. December 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terlipressin

The BfArM has implemented the decision of the CMDh dated 10 November 2022 regarding terlipressin-containing drugs at national level by official notice, dated 19 December 2022.

Direct Healthcare Professional Communication (DHPC) on terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) PDF, 448KB, File is accessible Date: 01. December 2022 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: terlipressin

Terlipressin may cause severe or lethal respiratory failure in patients with hepatorenal syndrome type 1 (HRS-1) with a higher frequency than previously known, as well as increase the risk of sepsis or septic shock.

Medicines containing nomegestrol or chlormadinone: risk of meningioma Date: 24. November 2022 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nomegestrol- and chlormadinone-containing medicines

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.