BfArM - Federal Institute for Drugs and Medical Devices

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Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: PRAC recommendation Date: 15. July 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for physicians and patients in order to make use of the medicinal product Zydelig® as safe as possible.

Fusafungin (Locabiosol®): increasing number of severe hypersensitivity reactions. Date: 09. May 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fusafungin

In its notice within the graduated plan procedure the BfArM revoked all marketing authorizations for fusafungin-containing medicinal products in Germany.

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Idelalisib

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia.

Inhalative corticosteroids (ICS) and pneumonia: recommendation by the PRAC Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: corticosteroids | inhalative

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has now completed its review of this known risk and has confirmed the increased risk of pneumonia.

Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: initiation of a European safety review Date: 15. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the initiation of a European safety review regarding Zydelig® due to serious adverse events. Zydelig® is authorised in the EU for treatment of two types of rare blood cancers.

Ambroxol and bromhexine: realisation of the EU Commission's implementing decision Date: 23. February 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

On 14 January 2016, the European Commission decided to update the texts of the Summaries of Product Characteristics/Package Leaflets of medicinal products containing ambroxol and bromhexine.

SGLT2 inhibitors: PRAC recommendation to minimise the risk of diabetic ketoacidosis, especially in atypical cases Date: 15. February 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has completed the European safety review on SGLT2 inhibitors and has issued recommendations to minimise the risk of diabetic ketoacidosis.

Ondansetron: contraindications and interactions if used concomitantly with apomorphine Date: 30. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ondansetron

BfArM issues a notice within the graduated plan procedure ("Stufenplanbescheid") concerning the implementation of information on contraindications and interactions if used concomitantly with apomorphine.

Codeine: review of the risk-benefit ratio of codeine-containing drugs for the treatment of cough in children and adolescents Date: 16. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: codeine

Treatment of cough in children younger than 12 years with medicinal products containing codeine is no longer permitted due to the risk of respiratory depression.

Educational material: Hearing of parallel importers pursuant to the graduated plan ("Stufenplan") Date: 13. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: different

Parallel importers are requested to comment in a hearing pursuant to the graduated plan.

Fumaderm: progressive multifocal leukoencephalopathy (PML), hearing within a graduated plan procedure ("Stufenplanverfahren"), stage II Date: 04. September 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fumarsäureester

After receiving reports of adverse reactions of currently nine cases of progressive multifocal leukoencephalopathy (PML) in connection with the use of Fumaderm®, the BfArM considers amendments of the section on adverse events in the product …

Ibuprofen-containing medicines: cardiovascular risk Date: 27. July 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ibuprofen

In its notice of 22 July 2015, the BfArM has ruled the realisation of the decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of 20 May 2015 regarding medicinal products containing …

SGLT2 inhibitors: initiation of a European safety review to evaluate the risk of diabetic ketoacidosis Date: 16. June 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: canagliflozin | dapagliflozin | empagliflozin

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.

Hydroxyzine: effects on heart rhythm Date: 20. May 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyzine

The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.

Quinine for nocturnal leg cramps (Limptar® N): BfArM's notice regarding changes of the product informations within a national graduated plan procedure ("Stufenplanverfahren"), including a restriction of the indication, amongst others due to the risk of severe blood count changes (thrombocytopenias) Date: 02. April 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.

Medicinal products containing ambroxol and bromhexine: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group (CMDh) within a European safety review concerning the risk of hypersensitivity reactions Date: 10. March 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ambroxol | bromhexine

The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with …

Polymyxin-based products (colistin, colistimethate sodium): realisation of the EU Commission's implementing decision Date: 30. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: colistin | colistimethate sodium

Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing …

Medicinal products containing testosterone: review of possible cardiac risks Date: 22. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: testosterone

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.

Medicinal products containing ponatinib (Iclusig®): risk of blood vessel blockage Date: 15. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Ponatinib

With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure for Iclusig® was completed.

Medicinal products containing valproate and related substances: risk of anomalies in neonates Date: 13. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment …

Medicinal products containing Estradiol for topical administration: realisation of the EU Commission's implementing decision Date: 09. January 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)6030 of 19 August 2014

Marketing authorisations based on studies conducted by GVK Biosciences in India: suspension of marketing authorisation Date: 09. December 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial conducted by GVK Biosciences in India.

Oral bromocriptine-containing medicines: indicated in the prevention or suppression of physiological lactation post-partum Date: 28. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: bromocriptine

In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing …

Medicinal products that affect the renin-angiotensin(-aldosterone) system (RAS/RAAS): realisation of the EU Commission's implementing decision Date: 13. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-Hemmer | Angiotensin-II-Rezeptor-Antagonisten | Aliskiren

In its notice of 31 October 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision (2014) 6371 of the EU Commission.

Levonorgestrel- and ulipristal acetate-containing medicines for emergency contraception: influence of body weight/BMI on efficacy/bioavailability Date: 07. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: levonorgestrel | ulipristal acetate

In its notice of 5 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision C(2014)7147of the EU Commission.

Use of valproate (and related substances) during pregnancy: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 10. October 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

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

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 …

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 …

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)