01.06.2023
|
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
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.
|
26.05.2023
|
Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product
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 batches of Emerade® pre-filled pens are recalled on patient level.
|
16.05.2023
|
Direct Healthcare Professional Communication (DHPC) on propofol: risk of sepsis with multiple withdrawals from one container
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.
|
30.03.2023
|
Methotrexate-containing medicinal products: improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA
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 will be described and discussed in detail in the next PSUSA procedure for methotrexatehaleradministered by the BfArM.
|
22.03.2023
|
Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration
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 administration.
|
17.03.2023
|
Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation
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 Janus kinase inhibitors therapy.
|
14.03.2023
|
Janus kinase inhibitors: Treatment of inflammatory disorders
Active substance: Janus kinase inhibitors
With the publication of the European Commission's decision on March 10, 2023, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Janus kinase inhibitors was completed. The warnings and precautions for using these medicines have been updated.
|
14.03.2023
|
Pholcodine: risk of anaphylactic reactions
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 risk assessment procedure under Article 107i of Directive 2001/83/EC on medicinal products containing pholcodine.
|
27.02.2023
|
Direct Healthcare Professional Communication (DHPC) on Cystagon 150 mg of the company Recordati Rare Diseases: Recall of batch T2208
Active substance: Mercaptamine bitartrate
Recordati Rare Diseases informs about a precautionary recall of batch T2208 of the medicinal product Cystagon 150 mg capsules.
|
15.02.2023
|
Marketing authorisations based on studies performed at the Semler Research Center (SRC) Private Ltd. company in India: suspension of marketing authorisations
Active substances: 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.
|
15.02.2023
|
Information Letter on Separation of the combined indications for methotrexate medac 25 mg/ml solution for injection (in vials)
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.
|
08.02.2023
|
Amfepramone: safety review
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 marketing authorisation holders of medicinal products containing amfepramone in Germany have declared a voluntary surrender of their marketing authorisations as of 01 December 2022.
|
06.02.2023
|
Direct Healthcare Professional Communication (DHPC) on amfepramone-containing medicines: Withdrawal and revocation of approvals
Active substance: amfepramone
Amfepramone-containing medicines are no longer available on the EU market, as marketing authorisations have been revoked respectively withdrawn.
|
03.01.2023
|
Sartans: contamination of active ingredients
Active substances: 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.
|
02.01.2023
|
Direct Healthcare Professional Communication (DHPC) on Caprelsa® (vandetanib): Restriction of indication
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.
|