BfArM - Federal Institute for Drugs and Medical Devices

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Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 793KB, File is accessible Date: 09. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Information on medicinal products traded illegally in Romania on the German market Date: 15. September 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: rituximab, trastuzumab

The Romanian medicines licensing authority (ANMDM) has informed the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) via the European Rapid Alert System that batches of 45 medicinal products traded by …

Domperidone: realisation of the EU Commission's implementing decision Date: 11. September 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: domperidone

In its notice of 8 September 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)5113. The European safety review according to …

Medicinal products containing zolpidem: risks to impairment of driving ability, attention and ability to react Date: 25. August 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: zolpidem

By decision of 22 August 2014, the Federal Institute for Drugs and Medical Devices (BfArM) implements the corresponding implementing decision of the EU Commission of 23 June 2014 on zolpidem-containing medicinal products. The Implementing …

Safety relevant information on Beta interferons: Risk of thrombotic microangiopathy and nephrotic syndrome PDF, 286KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon beta

In accord with the European Medicines Agency (EMA) and the marketing authorisation holders, the BfArM issues important safety information regarding the treatment of multiple sclerosis with medicinal products containing interferon beta.

Dear Doctor Letter (Rote-Hand-Brief) on domperidone: serious cardiac side effects PDF, 369KB, File is accessible Date: 20. August 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: domperidone

After conclusion of the European safety review of medicinal products containing domperidone, the marketing authorisation holders are circulating a joint Dear Doctor Letter with information on safety measures to minimise cardiac risks.

Methadone-containing drugs, with povidone (as pharmaceutical excipient): severe side effects due to misuse Date: 25. July 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Methadone

The BfArM issues information on the unanimous consensus of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) to suspend the marketing authorisation of oral methadone solutions containing high molecular …

Amsidyl® (active substance amsacrine) 75 MG concentrate for solution for infusion
(PZN 07131886) – Information on the shortage of Amsidyl after detection of GMP deficiencies during manufacture
PDF, 454KB, File is accessible
Date: 21. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Amsacrine

The pharmaceutical entrepreneur has issued information on a lack of availability of Amsidyl® until presumably 2015 due to the GMP deficiencies determined at the manufacturing site.

Information Letter on Velcade 3.5 MG (PZN 00822831) – Further information regarding the precautionary recall of a batch of Velcade (DELSC01) PDF, 269KB, File is accessible Date: 16. July 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Bortezomib

As a follow-up to the already published precautionary recall of a batch of Velcade®, the pharmaceutical manufacturer has compiled further information.

Medicinal product Corlentor®/Procoralan® (ivabradine): Initiation of a European safety review Date: 27. June 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ivabradine

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding Corlentor®/Procoralan® (ivabradine)

Dantrolene sodium (DANTROLEN i.v.®): Use of filter needles to draw up reconstituted solution from new stock until further notice PDF, 1MB, File is accessible Date: 27. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene sodium

The company Norgine GmbH is circulating information that some vials of dantrolene sodium for intravenous use after reconstitution may contain visible particles of the active substance.

Sutent® 25 mg and 50 mg hard capsules: BfArM issues warning regarding counterfeits of the medicinal product from Romania Date: 17. June 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: sunitinib

The Federal Institute for Medicinal Products and Medical Devices (BfArM) is circulating a warning against counterfeits of the 25 mg and 50 mg strengths of the cancer drug Sutent® produced by Pfizer. The counterfeits that are parallel imported …

Dear Doctor Letter (Rote-Hand-Brief) on transdermal patches containing fentanyl: Possible life-threatening consequences of accidental exposure PDF, 1MB, File is accessible Date: 13. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

The marketing authorisation holders are circulating information on possible life-threatening consequences of accidental exposure to patches containing fentanyl.

Information Letter on Procoralan®: Potentially dangerous bradycardia PDF, 1MB, File is accessible Date: 11. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH has issued a reminder that specific conditions for use must be observed in order to avoid potentially dangerous bradycardia when administering the medicinal product Procoralan® containing ivabradine for …

Rienso® (ferumoxytol): Risk of serious hypersensitivity reactions Date: 05. June 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: ferumoxytol

The EMA is in the process of evaluating all worldwide data available on serious hypersensitivity reactions in connection with administration of the medicinal product Rienso (ferumoxytol) which, however, is currently not being marketed in …

Dear Doctor Letter (Rote-Hand-Brief) on Invirase® (saquinavir): Important new safety information on ECG monitoring PDF, 467KB, File is accessible Date: 28. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

The company Roche Pharma AG is circulating information on new recommendations regarding ECG monitoring in treatment-naïve patients receiving Invirase® (saquinavir). This Dear Doctor Letter is intended to emphasise the necessity of ECG

Dear Doctor Letter (Rote-Hand-Brief) on Norditropin® SimpleXx® 10 mg/1.5 ml: Counterfeit PDF, 2MB, File is accessible Date: 23. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

The company Novo Nordisk Pharma GmbH is circulating information on the discovery of a counterfeit cartridge of the medicinal product Norditropin® SimpleXx® 10 mg/1.5 ml (active substance: somatropin).

Strontium ranelate containing medicinal products: risk of cardiavascular side effects Date: 19. May 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: strontium ranelate

The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 300KB, File is accessible Date: 09. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …

Medicinal products containing metoclopramide: realisation of the EU Commission's implementing decision Date: 15. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: metoclopramide

On 20 December 2013, the European Commission decided that high dose medicinal products containing metoclopramide should be removed from the market.

Ambroxol and bromhexine: start of a European safety review in accordance with Article 31 of Directive 2001/83/EC Date: 11. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC. This procedure was initiated at the request of the Belgian Federal Agency for Medicines and Health Products.

Combined hormonal contraceptives: realisation of the EU Commission's implementing decisions Date: 03. April 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: combined hormonal contraceptives

In its notice of 31 March 2014, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the corresponding implementing decisions of the EU Commission K(2014)307 of 16 January 2014.

Medicinal products containing pelargonium: risk of liver damage Date: 31. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: pelargonium

After having conducted a hearing within a graduated plan ("Stufenplan") procedure, the BfArM has now issued a notice regarding the risk of liver damage due to medicinal products containing pelargonium root.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotoxine: Restriction of indications PDF, 99KB, File is accessible Date: 27. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotoxine

The company Sigma-Tau Arzneimittel GmbH is circulating information that there are several indications for which medicinal products with the active substance dihydroergotoxine must no longer be prescribed in the future.

Granocyte® (lenograstim): Risk of capillary leak syndrome PDF, 309KB, File is accessible Date: 20. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenograstim

The company Chugai Pharma Marketing is circulating information on the occurrence of capillary leak syndrome (CLS) following administration of lenogastrim (as also in the case of other G-CSF products) in patients undergoing chemotherapy, as …

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication and recommendations for controls during administration PDF, 917KB, File is accessible Date: 11. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

The company Servier Deutschland GmbH is circulating information that use of Protelos is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men with a high risk of fractures who cannot be treated with other …

Medicinal products containing diacerein: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 07. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: diacerein

The BfArM issues information on the PRAC's recommendation within the re-examination procedure following a European safety review in accordance with Article 31 of Directive 2001/83/EC.

Information letter on Isotonic Saline Solution Baxter, Clear-Flex plastic containers with Emoluer valves: Recall due to leakage PDF, 91KB, File is accessible Date: 07. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isotonic saline

In addition to the safety information of 18 February 2014, the company Baxter Deutschland GmbH is circulating information on the recall of several batches of the medicinal product Isotonic Saline Solution Baxter.

Medicinal products containing domperidone: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 07. March 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: domperidone

The BfArM issues information on the PRAC's recommendation within a European safety review in accordance with Article 31 of Directive 2001/83/EC.

Information Letter on Doribax® 250 mg/500 mg (doripenem): Discontinuation and recall of stock in circulation PDF, 647KB, File is accessible Date: 05. March 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: doripenem

The company Janssen-Cilag GmbH points out that it will discontinue distribution of the medicinal product Doribax® 250 mg/500 mg (active substance: doripenem). The entire stock still on the market will be recalled on pharmacy level. This recall …