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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.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing fusafungine (Locabiosol®): revocation of marketing authorisation PDF, 262KB, File is accessible Date: 22. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fusafungine

By way of a Dear Doctor Letter, the company concerned is informing healthcare professionals of the revocation of the marketing authorisations of medicinal products containing fusafungine (Locabiosol® as mouth and nose spray) within the EU.

Dear Doctor Letter (Rote-Hand-Brief) on BCR-ABL tyrosine kinase inhibitors: Risk of reactivation of hepatitis B PDF, 339KB, File is accessible Date: 08. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: imatinib, dasatinib, nilotinib, bosutinib, ponatinib

The pharmaceutical companies concerned are circulating information on the risk of reactivation of hepatitis B after treatment with BCR-ABL tyrosine kinase inhibitors and the necessity of examining patients with regard to hepatitis B viral load …

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (idelalisib): Restrictions of use PDF, 319KB, File is accessible Date: 24. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on interim recommendations on restrictions of use of Zydelig.

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.

Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw PDF, 1MB, File does not meet accessibility standards Date: 17. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

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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.

Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material PDF, 167KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223 dichloride

The company Bayer Vital GmbH is circulating information that the National Institute of Standards and Technology (NIST) has recently revised the primary standardisation for Radium-223.

Information Letter on SGLT2 inhibitors: Updated information on the risk of diabetic ketoacidosis PDF, 192KB, File is accessible Date: 14. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: canagliflozin, dapagliflozin, empagliflozin

After completion of the European safety review by the CHMP, the pharmaceutical entrepreneurs concerned are circulating information on the recommendation to minimise the risk of diabetic ketoacidosis.

Dear Doctor Letter (Rote-Hand-Brief) on Myfortic® (mycophenolate): Serious risk of teratogenicity – reinforced advice on pregnancy prevention for women and men PDF, 180KB, File is accessible Date: 01. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate sodium

The company Novartis Pharma AG is circulating information in a Dear Doctor Letter that the advice regarding pregnancy prevention when using Myfortic® has been reinforced considerably.

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.

Protopic® – Herpes-simplex eye infections Date: 28. January 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Tacrolimus (topische Anwendung)

The BfArM points out that herpes simplex infections of the eye have been included as a new adverse reaction in the product information of Protopic®.

Dear Doctor Letter (Rote-Hand-Brief) on Fingolimod (Gilenya®): Risks related to the effects on the immune system PDF, 1MB, File is accessible Date: 20. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

The company Novartis Pharma GmbH is circulating information on recent product information changes in relation to immunosuppressive effects.

Mycophenolate (e.g. CellCept®): Update on the use of medicinal products containing mycophenolate during pregnancy after paternal exposure Date: 14. January 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Mycophenolat

The BfArM is issuing further information as a follow-up to the reinforced warning of 26 October 2015 regarding the use of mycophenolate (mycophenolate mofetil or mycophenolic acid) during pregnancy.

Educational Materials Date: 14. January 2016 Topics: Pharmakovigilanz Type: Article

Educational Materials

Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of indication PDF, 85KB, File is accessible Date: 14. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: erlotinib

The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.

Dear Doctor Letter (Rote-Hand-Brief) on Ampicillin+Sulbactam-ratiopharm® 1000/500 mg p.i. vials and Ampicillin+Sulbactam-ratiopharm® 2000/1000 mg p.i. vials: New information for use PDF, 133KB, File is accessible Date: 08. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ampicillin, sulbactam

The company Ratiopharm GmbH is circulating information that as a precautionary measure it is currently absolutely necessary to use a particle filter when administering the product.

Dear Doctor Letter (Rote-Hand-Brief) on Viekirax® (ombitasvir, paritaprevir, ritonavir) with or without Exviera® (dasabuvir): Important new safety information regarding liver function PDF, 444KB, File is accessible Date: 04. January 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ombitasvir, paritaprevir, ritonavir, dasabuvir

The company AbbVie Deutschland GmbH is circulating information on measures to reduce the risk of liver damage.

Information letters on Insuman® Basal and Insuman® Comb 25 - suspension for injection in 3-ml cartridges and Solo-Star® in pre-filled pens: Shortage Date: 01. December 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin human

The company Sanofi-Aventis Deutschland GmbH is sending out letters with the information that as of December 2015 the medicinal products Insuman® Basal and Insuman® Comb 25 will not be available at all or only limitedly due to capacity issues …

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): New measures to reduce the risk of progressive multifocal leukoencephalopathy PML - enhanced monitoring and stopping rules PDF, 715KB, File is accessible Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on important new measures to minimise the risk of progressive multifocal leukoencephalopathy (PML) during treatment with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on Fumaderm® initial / Fumaderm® (fumaric acid ester): Measures to reduce the risk of progressive multifocal leukoencephalopathy (PML)
PDF, 713KB, File is accessible
Date: 24. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid ester

After a hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II and conclusion of the variation worksharing procedure, the company Biogen Idec GmbH is circulating information on measures to reduce the risk of progressive …

Acitretin and teratogenicity: Compliance with safety measures in women of childbearing potential Date: 19. November 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: acitretin

On a European level it is currently being discussed that the 2-year period of pregnancy prevention in patients of childbearing potential is possibly not sufficient and must therefore be extended to 3 years after end of treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene® (Thalidomide): Reduction of starting dose when combined with melphalan in patients over 75 years of age PDF, 422KB, File is accessible Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Thalidomid

The company Celgene GmbH is circulating information that the starting dose of Thalidomide Celgene should be reduced when combined with melphalan and prednisone (MPT) in patients over 75 years of age with untreated multiple myeloma.

Dear Doctor Letter (Rote-Hand-Brief) on CellCept®: Serious risk of teratogenicity – strengthened advice on pregnancy prevention for women and men Date: 10. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma is circulating information that the advice regarding pregnancy prevention when using CellCept® has been strengthened considerably.

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Shortage PDF, 72KB, File is accessible Date: 05. November 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that the medicinal product InductOs can currently not be supplied.

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.

Mycophenolate (e.g. CellCept®): Strengthening of warnings in order to prevent use during pregnancy
Date: 26. October 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: mycophenolate

The European Medicines Agency (EMA) has issued a warning that the active substance mycophenolate used in transplantation medicine must not be administered during pregnancy if other treatment alternatives are available.

Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®) and progressive multifocal leukoencephalopathy (PML): Conclusion of the variation worksharing Date: 26. October 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Dimethylfumarat

The BfArM issues information that the variation worksharing procedure regarding progressive multifocal leukoencephalopathy in connection with the use of medicinal products containing dimethyl fumarate has been concluded.