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21.03.2016
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EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia
Active substance: Idelalisib
EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia.
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21.03.2016
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Inhalative corticosteroids (ICS) and pneumonia: recommendation by the PRAC
Active substances: 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.
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17.03.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw
Active substance: aflibercept
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15.03.2016
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Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: initiation of a European safety review
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.
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15.03.2016
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Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material
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.
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14.03.2016
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Information Letter on SGLT2 inhibitors: Updated information on the risk of diabetic ketoacidosis
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.
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01.03.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Myfortic® (mycophenolate): Serious risk of teratogenicity – reinforced advice on pregnancy prevention for women and men
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.
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23.02.2016
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Ambroxol and bromhexine: realisation of the EU Commission's implementing decision
Active substances: 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.
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15.02.2016
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SGLT2 inhibitors: PRAC recommendation to minimise the risk of diabetic ketoacidosis, especially in atypical cases
Active substances: 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.
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28.01.2016
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Protopic® – Herpes-simplex eye infections
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®.
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20.01.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Fingolimod (Gilenya®): Risks related to the effects on the immune system
Active substance: fingolimod
The company Novartis Pharma GmbH is circulating information on recent product information changes in relation to immunosuppressive effects.
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14.01.2016
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Mycophenolate (e.g. CellCept®): Update on the use of medicinal products containing mycophenolate during pregnancy after paternal exposure
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.
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14.01.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Tarceva® (erlotinib): Restriction of indication
Active substance: erlotinib
The company Roche Pharma AG is circulating a Dear Doctor Letter with information on restrictions regarding the indications of Tarceva®.
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08.01.2016
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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
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.
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04.01.2016
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Dear Doctor Letter (Rote-Hand-Brief) on Viekirax® (ombitasvir, paritaprevir, ritonavir) with or without Exviera® (dasabuvir): Important new safety information regarding liver function
Active substance: ombitasvir, paritaprevir, ritonavir, dasabuvir
The company AbbVie Deutschland GmbH is circulating information on measures to reduce the risk of liver damage.
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