Our news
- 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
- 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
- 03/04/2019: Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.
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- Phone: +7 985 908 58 18
- E-mail: info@regdrug.com
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Regulatory Events Russia
Russian Regulatory News
Pharegis LLC / ООО "Фареджис"
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3-1 Begovaya str. ("NordStar Tower", 31st flr), Moscow, Russia 125284
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Regulatory news
Drugs.com - New Drug Approvals
- FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults
- FDA Approves Calquence for Adults with Chronic Lymphocytic Leukemia
- FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria
- FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
- FDA Approves Adakveo (crizanlizumab-tmca) to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease
News and press releases
- Dutch authorities hand over final building to EMA in Amsterdam, , 15/11/2019
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated), CHMP, 15/11/2019
- EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots, CHMP, 15/11/2019
- Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada, CHMP, 15/11/2019
Drugs.com - Clinical Trials
- Results of a Randomized Study of the Safety and Efficacy of Cenobamate in Adults with Uncontrolled Focal Seizures Published in The Lancet Neurology PARAMUS, N.J., Nov. 13,...
- Anifrolumab Demonstrated Superiority Across Multiple Efficacy Endpoints in Patients with Systemic Lupus Erythematosus in Phase III TULIP 2 Trial November 11, 2019 --...
- AVEO Oncology and Biodesix Announce Initiation of the CyFi-2 Study, a Phase 2 Randomized Study of Ficlatuzumab in Combination with High-Dose Cytarabine vs. High-Dose Cytarabine Alone in Patients with Relapsed and Refractory AML CAMBRIDGE, Mass.--(BUSINESS...
- Genentech’s Risdiplam Meets Primary Endpoint In Pivotal SUNFISH Trial in People With Type 2 or 3 Spinal Muscular Atrophy South San Francisco, CA --...