BfArM - Federal Institute for Drugs and Medical Devices

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Medicinal products containing valproate: risks of use during pregnancy Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition …

Medicinal products containing valproate: risks of use during pregnancy PDF, 103KB, File is accessible Date: 21. March 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Valproate

A notice of annulment was sent out for medicinal products for which the marketing authorisation holder had renounced the marketing authorisation.

Medicinal products containing valproate: risks of use during pregnancy Date: 10. March 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Introduction of a patient alert card for medicinal products containing valproate

SGLT2 inhibitors (prviously canagliflozin): possibly increased risk of lower-extremity amputations Date: 10. February 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Canagliflozin | Dapagliflozin | Empagliflozin

The BfArM issues information on the extension of the European safety review regarding canagliflozin to include all SGLT2 inhibitors.

Medicinal products containing colchicine (Colchysat Bürger®) and reports of medication errors: restriction of pack size to 30 ml - hearing within a graduated plan procedure ("Stufenplanverfahren"), stage II Date: 09. February 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colchicine

The BfArM issues information on the initiation of a graduated plan procedure concerning the medicinal product Colchysat Bürger®.

iCalcium folinate and 5-fluorouracil: incompatibilities between the injectable forms Date: 21. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: calcium folinate | 5-fluorouracil

The BfArM has initiated a graduated plan procedure ("Stufenplanverfahren") in order to update the product informations of medicinal products containing calcium folinate for injection.

Injectable allergy medications containing methylprednisolone that include traces of cows' milk proteins: risk of allergic reactions Date: 06. December 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methylprednisolone

At the request of Croatia, the European Medicines Agency EMA has initiated a review procedure on 1 December 2016. It concerns injectable medicinal products with the active substance methylprednisolone that additionally contain lactose from …

Marketing authorisations based on studies conducted by the company Alkem Laboratories Ltd. in India: suspension of marketing authorisation Date: 14. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Riluzol

In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a clinical trial conducted by the company Alkem Laboratories …

Metformin for treatment of type 2 diabetes: use is extended to patients with moderately reduced kidney function Date: 03. November 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: metformin

As of 14 October 2016 and based on a European safety review, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended further lowering the limit of the creatinine clearance above which …

Medicinal products containing hydroxyethyl starch (HES): review of the risk-benefit ratio Date: 18. October 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

In its notice of 12 October 2016, the BfArM has ruled suspension of the marketing authorisations until 1 November 2017. This notice is not legally enforceable. It is currently permitted to place the medicinal products on the market.