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Citizens Menu
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- Pharmacovigilance / «Citizens»
- PRAC recommends restricting use of prostate cancer medicine Xofigo
- PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
- EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
- Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone. Ongoing clinical study shows an increased risk of death and fractures with the combination
- PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids
- PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place
- Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
- PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
- Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone
- EMA starts review of Esmya for uterine fibroids
- PRAC concludes review of medicines containing factor VIII
- PRAC investigates cancer medicine docetaxel
- PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations Review finds evidence of gadolinium deposits in the brain after MRI body scans but no signs of harm
- New review of valproate use in pregnancy and women of childbearing age
- EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
- PRAC reviewing safety of pulmonary hypertension medicine Uptravi
- PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
- EMA to review certain injectable medicines to treat allergy
- PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
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Specialists Menu
- Announcements
- MEASURES FOR PREVENTION OF WNV TRANSFUSION TRANSMISSION – 2019
- EMA reviews multiple sclerosis medicine Zinbryta
- PRAC investigates cancer medicine docetaxel
- New review of valproate use in pregnancy and women of childbearing age
- EMA starts review of retinoid medicines
- Review of factor VIII medicines begins
- Extension of the scope of a safety review
- Practice run on public hearings
- PRAC concludes review of Zydelig and issues updated recommendations for use EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig
- EMA to review modified-release paracetamol
- Pharmacovigilance
- PRAC recommends new measures to avoid dosing errors with methotrexate
- Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use
- PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids
- EMA reviewing risk of dosing errors with methotrexate - Review prompted by continued reports of overdose
- Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone. Ongoing clinical study shows an increased risk of death and fractures with the combination
- PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids
- PRAC recommends new measures to avoid valproate exposure in pregnancy New restrictions on use; pregnancy prevention programme to be put in place
- Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
- PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
- Warning about use of prostate cancer medicine Xofigo in combination with Zytiga and prednisone or prednisolone
- NCA for blood
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- Announcements - Medical devices
- Гръдни импланти на френската фирма PIP (“Poly Implant Prothese”) – резултати от тестове
- Блокиране на медицински изделия - дезинфекциращи кърпички на производителя “TRIAD GROUP”, САЩ
- Доклад на EBA Europheresis Group
- Гръдните импланти на френската фирма PIP (“Poly Implant Prothese”) – изтеглени от пазара
- Pharmacopoeia
- Announcements for pharmacovigilance
- EU regulations / «Pharmacovigilance»
- BDA instructions / «Pharmacovigilance»
- E-reporting / «Pharmacovigilance»
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