BfArM - Federal Institute for Drugs and Medical Devices

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107 results

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Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury Date: 03. August 2018 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ulipristal acetate

The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.

Flupirtine: implementation of revocation of marketing authorisation Date: 24. May 2018 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: flupirtine

In its notices and/or ascertainment decision of 26 April 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the unanimous CMDh position of 21 March 2018.

Oral and rectal dosage forms of antiemetic agents containing dimenhydrinate and diphenhydramine for children up to the age of 3 years Date: 22. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dimenhydrinate | diphenhydramine

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the conclusion of the graduated plan procedure ("Stufenplanverfahren") regarding the use of oral and rectal antiemetic agents containing …

Medicinal products containing modified-release paracetamol: measures for risk minimisation and to reduce harm in case of overdose Date: 15. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: paracetamol - modified release

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the PRAC recommendation that the marketing authorisations of medicinal products containing modified or prolonged release paracetamol shall be …

Terfenadine: closer monitoring of the side-effect profile PDF, 77KB, File is accessible Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: terfenadine

After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.

Xofigo®: EMA restricts use of prostate cancer medicine Xofigo Date: 04. December 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Radium-223 dichloride

Medicine should only be used after two previous treatments or when other treatments cannot be taken.

Marketing authorisations based on studies conducted by the company Micro Therapeutic Research Labs in India: suspension of marketing authorisations Date: 13. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 13 July 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the provisional suspension of generic marketing authorisations based on clinical trials conducted by the company Micro Therapeutic Research …

Symbioflor 2: recommendations of the Committee for Medicinal Products for Human Use regarding further use and restrictions of use Date: 04. July 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: escherichia coli

In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called …

Direct-acting antivirals used for treating Hepatitis C: possible hepatitis B re-activation Date: 05. May 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir

The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C

Dienogest 2 mg and ethinylestradiol 0.03 mg for treatment of acne: use for treatment of acne possible if other specific treatments are not effective Date: 18. April 2017 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dienogest, ethinylestradiol

In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety …

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.