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There were 1,655 press releases posted in the last 24 hours and 346,985 in the last 365 days.

Press Releases on September 17, 2018

1,839 Press Releases

Published on September 17, 2018 - 12:13 GMT

IIROC Trading Halt / Suspension de la negociation par l'OCRCVM - BMO.PR.E (All Issues)

TORONTO, Sept. 17, 2018 (GLOBE NEWSWIRE) -- The following issues have been halted by IIROC / L’OCRCVM a suspendu la négociation des titres suivants : Company / Société : Bank of Montreal TSX Symbol / Symbole TSX : BMO.PR.E All Issues / les Titres: No/ …

Distribution channels: Banking, Finance & Investment Industry
Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, Date of authorisation: 20/11/...

Apealea is a cancer medicine used to treat women with cancer of the ovary or surrounding structures (the fallopian tube that connects the ovary to the womb, or the peritoneum, the membrane that lines the abdomen). Apealea is given along with a platinum- …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Apealea, paclitaxel, Ovarian Neoplasms, Date of authorisation: 20/11/...

Apealea is a cancer medicine used to treat women with cancer of the ovary or surrounding structures (the fallopian tube that connects the ovary to the womb, or the peritoneum, the membrane that lines the abdomen). Apealea is given along with a platinum- …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Excipients in the dossier for application for marketing authorisation for veterinary medicinal products - Scientific guideline

Note for guidance: Excipients in the dossier for application for marketing authorisation for veterinary medicinal products (PDF/40.87 KB) Adopted First published: 01/02/1999 Last updated: 01/02/1999 Legal effective date: 01/06/1999 EMEA/CVMP/004/98 - FINAL

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

CVMP: Agendas, minutes and reports

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia;Hematopoietic Stem Cell ...

The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Filgrastim Hexal, filgrastim, Neutropenia;Hematopoietic Stem Cell ...

The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders;Diabetic Neuropathies;Depressive ...

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Revolade, eltrombopag, Purpura, Thrombocytopenic, Idiopathic, Date of ...

ITP in adults For the treatment of ITP in adults, Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 patients who had previously been treated, but those treatments had not worked or the disease had come back …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Revolade, eltrombopag, Purpura, Thrombocytopenic, Idiopathic, Date of ...

ITP in adults For the treatment of ITP in adults, Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 patients who had previously been treated, but those treatments had not worked or the disease had come back …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Orphan designation: Recombinant human acid alpha-glucosidase, Treatment of glycogen storage disease type II (Pompe's disease), 21/...

At the time of designation, glycogen storage disease type II affected approximately 0.3 in 10,000 people in the European Union (EU). This was equivalent to a total of around 16,000 people*, and is below the ceiling for orphan designation, which is 5 people …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Orphan designation: Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa), Treatment of ...

This medicine is now known as dalcinonacog alfa. On 20 June 2017, orphan designation (EU/3/17/1884) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for recombinant human factor IX protein modified with three point mutations ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, Date of authorisation: 14/06/...

Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, Date of authorisation: 14/06/...

Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Orphan designation: (1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-...

On 4 December 2007, orphan designation (EU/3/07/514) was granted by the European Commission to Genzyme Europe BV, Netherlands, for (1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L- …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, Date of ...

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:12 GMT

Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, Date of ...

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:11 GMT

Plasma master file certificates

CSL Behring EMEA/H/PMF/000001/04 AU/026/G Annual Update Re-Certification 2023-01-26 Sep-23 CSL Behring EMEA/H/PMF/000001/04 AU/025/G Annual Update Re-Certification 2022-02-24 Sep-22 CSL Behring EMEA/H/PMF/000001/04 II/024/G Type II variation 2021-07-22 Sep …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:11 GMT

Academia

EMA seeks the expert input of healthcare professionals (i.e. academics, researchers, clinicians) and patients in its work through several channels, including: If the Agency needs expert input to help with a particular activity or piece of work, other …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Ovarian Neoplasms;Uterine Cervical Neoplasms;Small ...

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of …

Distribution channels: Healthcare & Pharmaceuticals Industry

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