VARITECT

Main information

  • Trade name:
  • VARITECT Solution for Injection
  • Active ingredient:
  • HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER
  • Available from:
  • Biotest Pharma GmbH
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine type:
  • Human

Localization

  • Available in:
  • Ireland
  • Language:
  • English

Therapeutic information

Status

  • Source:
  • IMB
  • Authorization date:
  • 1995-04-21

Documents

29-6-2015

Fimea will bring in the Common Repository database on 1 July 2015

Fimea will bring in the Common Repository database on 1 July 2015 Fimea will introduce the Common Repository database of the European Medicines Agency starting from 1 July 2015. All national authorities will be simultaneously obliged to use the database in the centralised marketing authorisation procedure for medicinal products for human use. After the deployment of the CR database, applicants for marketing authorisation no longer need to submit their application documents separately to the natio...

Finland - Fimea News

27-6-2015

Scientific Opinion on nitrofurans and their metabolites in food

EFSA Panel on Contaminants in the Food Chain (CONTAM) Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human health related to the presence of nitrofurans in food and whether a reference point for action (RPA) of 1.0 µg/kg for the marker metabolites is ...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-6-2015

Scientific Opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin

EFSA Panel on Contaminants in the Food Chain (CONTAM) The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. THC, more precisely delta-9-tetrahydrocannabinol (Δ9-THC) is derived from the hemp plant Cannabis sativa. In fresh plant material, up to 90 % of total Δ9-THC is present as the non-psychoactive precursor Δ9-THC acid...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-6-2015

Drivers for occasional spillover event of Ebola virus

European Food Safety Authority In order to identify the drivers for spillover of Ebola virus from animal to humans, a set of drivers for spillover of infectious diseases was identified from the literature. A subset of scientific studies was used to structure a corpus of relevant arguments. This corpus was used to analyse the driver network and visualise the driver behaviour. The analysis led to the identification of 40 drivers, connected through 142 linkages. The visualisation of the driver netwo...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-6-2015

Risks for public health related to the presence of chlorate in food

EFSA Panel on Contaminants in the Food Chain (CONTAM) Following a request from the European Commission, the risks to human health related to the presence of chlorate in food were assessed by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel). The presence of chlorate in food can arise from the use of chlorinated water for food processing and the disinfection of food-processing equipment. Inhibition of iodine uptake in humans was identified as the critical effect for chronic exposure ...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-6-2015

Scientific Opinion on the application (EFSA-GMO-BE-2012-110) for the placing on the market of tissue-selective herbicide-tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Mo

EFSA Panel on Genetically Modified Organisms (GMO) Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue-selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of ma...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-6-2015

Scientific Opinion on application (EFSA-GMO-NL-2012-108) for the placing on the market of the herbicide-tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsa

EFSA Panel on Genetically Modified Organisms (GMO) Single events MON 87708 and MON 89788 were combined to produce the stack two-event soybean MON 87708 × MON 89788. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single soybean events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-6-2015

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015

Ten new medicines, including two enzyme replacement therapies for rare diseases, recommended for approval

Europe - EMA - European Medicines Agency

24-6-2015

RAPLIXA (Fibrinogen Human And Thrombin Human) Powder [ProFibrix BV]

Updated Date: Jun 24, 2015 EST

US - DailyMed