ATOX COMBO PEN

Glavne informacije

  • Zaščiteno ime:
  • ATOX COMBO PEN Auto Injector raztopina za injiciranje
  • Farmacevtska oblika:
  • raztopina za injiciranje
  • Pot uporabe:
  • Način uporabe nedoločen
  • Enote v paketu:
  • škatla s 100 napolnjenimi injekcijskimi peresniki z 2 ml raztopine
  • Tip zastaranja:
  • / - Način/režim izdaje ni določen.
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • ATOX COMBO PEN Auto Injector raztopina za injiciranje
    Slovenija
  • Jezik:
  • slovenščina

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z začasnim dovoljenjem za vnos/uvoz za posamično zdravl
  • Datum dovoljenje:
  • 07-10-2009
  • Zadnja posodobitev:
  • 19-01-2018

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  NexGard, afoxolaner, Opinion date: 13-Sep-2018

Pending EC decision: NexGard, afoxolaner, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

27-7-2018

Pending EC decision:  Opdivo, nivolumab, Opinion date: 26-Jul-2018

Pending EC decision: Opdivo, nivolumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Pending EC decision: Ilumetri, tildrakizumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Pending EC decision: Gefitinib Mylan, gefitinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Pending EC decision: Kigabeq, vigabatrin, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Kalydeco, ivacaftor, Opinion date: 26-Jul-2018

Pending EC decision: Kalydeco, ivacaftor, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Hulio, adalimumab, Opinion date: 26-Jul-2018

Pending EC decision: Hulio, adalimumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Mekinist, trametinib, Opinion date: 26-Jul-2018

Pending EC decision: Mekinist, trametinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Tafinlar, dabrafenib, Opinion date: 26-Jul-2018

Pending EC decision: Tafinlar, dabrafenib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Verzenios, abemaciclib, Opinion date: 26-Jul-2018

Pending EC decision: Verzenios, abemaciclib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Xerava, eravacycline, Opinion date: 26-Jul-2018

Pending EC decision: Xerava, eravacycline, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Onpattro, patisiran, Opinion date: 26-Jul-2018

Pending EC decision: Onpattro, patisiran, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Nucala, mepolizumab, Opinion date: 26-Jul-2018

Pending EC decision: Nucala, mepolizumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Xarelto, rivaroxaban, Opinion date: 26-Jul-2018

Pending EC decision: Xarelto, rivaroxaban, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Symkevi, tezacaftor / ivacaftor, Opinion date: 26-Jul-2018

Pending EC decision: Symkevi, tezacaftor / ivacaftor, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Abseamed, epoetin alfa, Opinion date: 26-Jul-2018

Pending EC decision: Abseamed, epoetin alfa, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Blincyto, blinatumomab, Opinion date: 26-Jul-2018

Pending EC decision: Blincyto, blinatumomab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Binocrit, epoetin alfa, Opinion date: 26-Jul-2018

Pending EC decision: Binocrit, epoetin alfa, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Imfinzi, durvalumab, Opinion date: 26-Jul-2018

Pending EC decision: Imfinzi, durvalumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Mektovi, binimetinib, Opinion date: 26-Jul-2018

Pending EC decision: Mektovi, binimetinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Braftovi, encorafenib, Opinion date: 26-Jul-2018

Pending EC decision: Braftovi, encorafenib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Udenyca, pegfilgrastim, Opinion date: 26-Jul-2018

Pending EC decision: Udenyca, pegfilgrastim, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Darzalex, daratumumab, Opinion date: 26-Jul-2018

Pending EC decision: Darzalex, daratumumab, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Slenyto, melatonin, Opinion date: 26-Jul-2018

Pending EC decision: Slenyto, melatonin, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Pelgraz, pegfilgrastim, Opinion date: 26-Jul-2018

Pending EC decision: Pelgraz, pegfilgrastim, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-9-2018

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin

We want to help patients/caregivers know how to use pen needles correctly. FDA received reports of patients using standard pen needles to inject insulin w/o removing the inner needle cover. The cover stopped patients from getting the right amnt of insulin https://go.usa.gov/xPWZq  pic.twitter.com/LT9SptJge1

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety