DOCETAXEL PHARMAKI GENERICS 20 MG/0,5 ML

Základní informace

  • Název přípravku:
  • DOCETAXEL PHARMAKI GENERICS 20 MG/0,5 ML, INF CSL LQF 1X0.5ML/20MG
  • Dávkování:
  • 20MG/0.5ML
  • Podání:
  • Infuze
  • Jednotky v balení:
  • 1X0.5ML+SOL, Injekční lahvička
  • Druh předpisu:
  • Léčiva na lékařský předpis
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • DOCETAXEL PHARMAKI GENERICS 20 MG/0,5 ML, INF CSL LQF 1X0.5ML/20MG
    Česká republika
  • Jazyk:
  • čeština

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Stav Autorizace:
  • R - registrovaný léčivý přípravek.
  • Registrační číslo:
  • 44/ 635/11-C
  • Poslední aktualizace:
  • 08-11-2016

20-6-2018

Enforcement Report for the Week of June 20, 2018

Enforcement Report for the Week of June 20, 2018

FDA - U.S. Food and Drug Administration

25-5-2018

Dough-To-Go Issues Allergy Alert on Undeclared Tree Nuts in Zoe’s Vegan Tuxedo Fudge Cookie

Dough-To-Go Issues Allergy Alert on Undeclared Tree Nuts in Zoe’s Vegan Tuxedo Fudge Cookie

Dough-to-Go of Santa Clara, CA is recalling 20 cases of cookies because they may contain undeclared tree nuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-5-2018

Viibryd Starter Kit (10 & 20 mg)

Viibryd Starter Kit (10 & 20 mg)

Health Canada

2-5-2018

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

FDA - U.S. Food and Drug Administration

1-3-2018

All marketing authorisation letters are now sent electronically to Danish companies

All marketing authorisation letters are now sent electronically to Danish companies

On 20 February 2018, the Danish Medicines Agency extended its use of digital post and now sends all letters, and not just decisions, about marketing authorisations electronically to Danish companies.

Danish Medicines Agency

20-12-2017

Enforcement Report for the Week of December 20, 2017

Enforcement Report for the Week of December 20, 2017

FDA - U.S. Food and Drug Administration

20-11-2017

SÚKL se zapojil do celoevropské kampaně zaměřené na hlášení podezření na nežádoucí účinky léčiv

SÚKL se zapojil do celoevropské kampaně zaměřené na hlášení podezření na nežádoucí účinky léčiv

Státní ústav pro kontrolu léčiv se zapojil do celoevropské kampaně „The 2nd European Union-wide adverse drug reaction (ADR) awareness week campaign” která se uskuteční od 20. do 24. listopadu 2017.

Český Republich - SUKL - State Institute for Drug Control

1-11-2017

Tamo 20 tablets

Tamo 20 tablets

Tamo 20 tablets may pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

20-9-2017

Enforcement Report for the Week of September 20, 2017

Enforcement Report for the Week of September 20, 2017

FDA - U.S. Food and Drug Administration

23-6-2017

Substantial progress in cooperation with CFDA only six weeks after state visit

Substantial progress in cooperation with CFDA only six weeks after state visit

During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and i...

Danish Medicines Agency

20-7-2016

Enforcement Report for the Week of July 20, 2016

Enforcement Report for the Week of July 20, 2016

FDA - U.S. Food and Drug Administration

6-5-2016

Receipt of clinical trial applications (CTA) summer 2016

Receipt of clinical trial applications (CTA) summer 2016

Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications from 20 June to 15 August 2016.

IMA - Icelandic Medicines Agency

20-4-2016

Enforcement Report for the Week of April 20, 2016

Enforcement Report for the Week of April 20, 2016

FDA - U.S. Food and Drug Administration

20-1-2016

Enforcement Report for the Week of January 20, 2016

Enforcement Report for the Week of January 20, 2016

FDA - U.S. Food and Drug Administration

20-5-2015

Enforcement Report for the Week of May 20, 2015

Enforcement Report for the Week of May 20, 2015

FDA - U.S. Food and Drug Administration

20-8-2014

Enforcement Report for the Week of August 20, 2014

Enforcement Report for the Week of August 20, 2014

FDA - U.S. Food and Drug Administration

15-1-2014

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

Revocation of wholesale distribution and manufacturing authorisations granted to Singad Pharma ApS

On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products with the authorisation IDs 25081 and 25082 granted to Singad Pharma ApS (company number 255894).

Danish Medicines Agency

20-11-2013

Enforcement Report for the Week of November 20, 2013

Enforcement Report for the Week of November 20, 2013

FDA - U.S. Food and Drug Administration

20-3-2013

Enforcement Report for the Week of March 20, 2013

Enforcement Report for the Week of March 20, 2013

FDA - U.S. Food and Drug Administration

20-2-2013

Enforcement Report for the Week of February 20, 2013

Enforcement Report for the Week of February 20, 2013

FDA - U.S. Food and Drug Administration

17-1-2013

Danish Pharmacovigilance Update, 20 December 2012

Danish Pharmacovigilance Update, 20 December 2012

In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.

Danish Medicines Agency

17-10-2012

Danish Pharmacovigilance Update, 20 September 2012

Danish Pharmacovigilance Update, 20 September 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.

Danish Medicines Agency

20-6-2012

Enforcement Report for the Week of June 20, 2012

Enforcement Report for the Week of June 20, 2012

FDA - U.S. Food and Drug Administration

2-2-2012

Applications for general reimbursement in 2011

Applications for general reimbursement in 2011

In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.

Danish Medicines Agency

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety

16-5-2018

 Minutes - PDCO minutes of the 20-23 February 2018 meeting

Minutes - PDCO minutes of the 20-23 February 2018 meeting

Europe - EMA - European Medicines Agency

16-5-2018

 Minutes - PDCO minutes of the 20-23 March 2018 meeting

Minutes - PDCO minutes of the 20-23 March 2018 meeting

Europe - EMA - European Medicines Agency

16-5-2018

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

27-11-2017

Docetaxel

Docetaxel

Docetaxel (Active substance: Docetaxel) - Centralised - Art 28 - (PSUR - Commission Decision (2017)7984 of Mon, 27 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1152/201611

Europe -DG Health and Food Safety

21-7-2017

Pending EC decision:  Verkazia, ciclosporin, Opinion date: 20-Jul-2017

Pending EC decision: Verkazia, ciclosporin, Opinion date: 20-Jul-2017

Europe - EMA - European Medicines Agency