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- Pharmacovigilance / «Citizens»
- Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
- Restrictions in use of cyproterone due to meningioma risk
- PRAC confirms four-week limit for use of high-strength estradiol creams
- PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
- PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
- 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
- EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
- PRAC recommends new measures to avoid dosing errors with methotrexate
- 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
- Medicines
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- Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
- Restrictions in use of cyproterone due to meningioma risk
- PRAC confirms four-week limit for use of high-strength estradiol creams
- PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
- PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
- 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
- Administrative information
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
- Medicines
- Pharmacovigilance
- PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
- New measures to avoid handling errors with leuprorelin depot medicines
- Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk
- New testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine
- Restrictions in use of cyproterone due to meningioma risk
- PRAC recommends measures to minimise risk of serious side effects with Lemtrada for multiple sclerosis
- PRAC recommends cautious use of Xeljanz for all patients at high risk of blood clots
- 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
- NCA for blood
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- Recommendations to the Sponsors for managing of Clinical Trials during the COVID-19 pandemic and the declared State of emergency in the Republic of Bulgaria
- Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited"
- Ethics Committee
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- Control of the medicinal products
- 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
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