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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.