VARITECT

Main information

  • Trade name:
  • VARITECT Solution for Injection
  • 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

21-7-2015

Scientific Opinion on the substantiation of a health claim related to β-galactosidase from <i>Kluyveromyces lactis</i> in Colief® and a reduction of gastrointestinal discomfort pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following an application from Cross Vetpharm Group UK Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to β-galactosidase from Kluyveromyces lactis in Colief® and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2015

Scientific Opinion on an application (Reference EFSA-GMO-NL-2011-100) for the placing on the market of the herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regu

EFSA Panel on Genetically Modified Organisms (GMO) The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2015

Scientific Opinion on an application (EFSA-GMO-BE-2011-98) for the placing on the market of herbicide-tolerant genetically modified soybean FG72 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience

EFSA Panel on Genetically Modified Organisms (GMO) Soybean FG72 was developed by biolistic transformation to express the HPPD W336 and 2mEPSPS proteins, which confer tolerance to isoxaflutole- and glyphosate-based herbicides. The molecular characterisation of soybean FG72 did not give rise to safety issues. The agronomic and phenotypic characteristics of soybean FG72 tested under field conditions revealed no biologically relevant differences between soybean FG72 and its conventional counterpart t...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-7-2015

TACHOSIL (Thrombin Human And Fibrinogen) Patch [Baxter Healthcare Corporation]

Updated Date: Jul 28, 2015 EST

US - DailyMed

24-7-2015

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015

Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU

Europe - EMA - European Medicines Agency