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BULA!
http://www.apotheke-adhoc.de//nachr...uf-der-zulassung-fuer-kava-kava-rechtswidrig/
Google Translation of article:
6/18/2014 PHARMA ADHOC
PHARMA ADHOC - The industry at a glance
PHYTOPHARMAKA
Court rehabilitated kava kava PHARMA ADHOC,
06.17.2014 15:31
Published on PHARMA ADHOC http://www.apotheke-adhoc.de © Elke Hinkelbein
New opportunity for kava kava? In 2004 activists protested for kava kava. The withdrawal of authorization by the BfArM in 2007 was, according to the Cologne Administrative Court unlawful.
Berlin - Six years ago, has revoked the approval for kava kava-containing medicines, the Federal Institute for Drugs and Medical Devices (BfArM) - now the herbal anxiolytic could come back. Since 2001, the manufacturer and the BfArM argue about the approval. The Cologne Administrative Court has now ruled that the revocation of the approval was illegal. The decision is not yet final.
The dispute about kava kava and kavain-containing drugs began in 2001: The BfArM initiated due to suspected cases in Switzerland, a phased process. After consulting the manufacturer, the Authority revoked the approval mid 2002. The drugs were suspected to be able to cause severe hepatotoxic reactions. The company filed an opposition, and the BfArM ordered a suspension of admission to. Because the authority with the companies and the Federal Association of Pharmaceutical Manufacturers (BAH) but could not agree on which studies must be submitted to the BfArM revoked the approval in December 2007 again. Except homeopathic preparations are at a final concentration
from D5 and medicines that are prepared according to the technique of spagyrik Zimpel.
The judges have now canceled this revocation. They stressed: The authorization can only be withdrawn if the benefit-risk ratio of a drug legally subsequently as unfavorable. This is possible, if it is established that could not achieve therapeutic results with the drug.
But mere doubts about the effectiveness was not sufficient. The assessment of the risk demand reasonably suspects for side effects. Hypotheses and unverifiable assumptions are not appropriate. Benefits and risks would finally be weighed against each other in a third step.
The Administrative Court made it clear that the assessment of whether the risk-benefit ratio is unfavorable, completely subject to judicial review. BfArM am at no own discretion.
The judges are convinced that the benefit-risk ratio for kava kava containing products is not as unfavorable: The BfArM had a "certain" efficacy at higher doses stated, so do not be assumed, the drug would be ineffective.
The number of messages to side effects, however, is the view of the judge is not unusually high: in Germany alone, 250 million days doses were in the decade before the ban was issued - there had been 48 reports in Germany and 110 worldwide. The case material is content "nor consistent": Of the 48 notifications from Germany would be only 26 well documented regarded as sufficient.
When weighing the benefits and risks, the judges compared the treatment with kava kava drugs with the use of benzodiazepines. Of these agents go from the perspective of the judges "significant risks" from: Benzodiazepines have a high potential for dependence and apply as a drug with the highest rate of abuse. Since 2002 there have been almost 4500 messages to side effects.
A total of seven methods have been tried in court. Before revoking had almost all the major manufacturers a Kava Kava product on the market, including Schwabe (Laitan) Lichtwer (Maoni) Krewel-Meuselbach (Antares), Harras (kavain) Kytta (Kytta-kava), Bionorica ( Kavatino) and Queisser (Jakava).
Source URL (retrieved on 18/06/2014 - 16:00): http://www.apotheke-adhoc.de/nachri...-koeln-widerruf-der-zulassung-fuer-kava-kava- rechtswidrig/
Copyright © 2007 - 2014, PHARMA ADHOC is a service provided by EL PATO Ltd.. - Agentur für Kommunikation. Skalitzer road 68/10997 Berlin Managing Director: Patrick Hollstein, Elke Hinkelbein / Amtsgericht Berlin Charlottenburg / HRB 100 205 B / VAT Reg. DE246500697.
Google Translation of article:
6/18/2014 PHARMA ADHOC
PHARMA ADHOC - The industry at a glance
PHYTOPHARMAKA
Court rehabilitated kava kava PHARMA ADHOC,
06.17.2014 15:31
Published on PHARMA ADHOC http://www.apotheke-adhoc.de © Elke Hinkelbein
New opportunity for kava kava? In 2004 activists protested for kava kava. The withdrawal of authorization by the BfArM in 2007 was, according to the Cologne Administrative Court unlawful.
Berlin - Six years ago, has revoked the approval for kava kava-containing medicines, the Federal Institute for Drugs and Medical Devices (BfArM) - now the herbal anxiolytic could come back. Since 2001, the manufacturer and the BfArM argue about the approval. The Cologne Administrative Court has now ruled that the revocation of the approval was illegal. The decision is not yet final.
The dispute about kava kava and kavain-containing drugs began in 2001: The BfArM initiated due to suspected cases in Switzerland, a phased process. After consulting the manufacturer, the Authority revoked the approval mid 2002. The drugs were suspected to be able to cause severe hepatotoxic reactions. The company filed an opposition, and the BfArM ordered a suspension of admission to. Because the authority with the companies and the Federal Association of Pharmaceutical Manufacturers (BAH) but could not agree on which studies must be submitted to the BfArM revoked the approval in December 2007 again. Except homeopathic preparations are at a final concentration
from D5 and medicines that are prepared according to the technique of spagyrik Zimpel.
The judges have now canceled this revocation. They stressed: The authorization can only be withdrawn if the benefit-risk ratio of a drug legally subsequently as unfavorable. This is possible, if it is established that could not achieve therapeutic results with the drug.
But mere doubts about the effectiveness was not sufficient. The assessment of the risk demand reasonably suspects for side effects. Hypotheses and unverifiable assumptions are not appropriate. Benefits and risks would finally be weighed against each other in a third step.
The Administrative Court made it clear that the assessment of whether the risk-benefit ratio is unfavorable, completely subject to judicial review. BfArM am at no own discretion.
The judges are convinced that the benefit-risk ratio for kava kava containing products is not as unfavorable: The BfArM had a "certain" efficacy at higher doses stated, so do not be assumed, the drug would be ineffective.
The number of messages to side effects, however, is the view of the judge is not unusually high: in Germany alone, 250 million days doses were in the decade before the ban was issued - there had been 48 reports in Germany and 110 worldwide. The case material is content "nor consistent": Of the 48 notifications from Germany would be only 26 well documented regarded as sufficient.
When weighing the benefits and risks, the judges compared the treatment with kava kava drugs with the use of benzodiazepines. Of these agents go from the perspective of the judges "significant risks" from: Benzodiazepines have a high potential for dependence and apply as a drug with the highest rate of abuse. Since 2002 there have been almost 4500 messages to side effects.
A total of seven methods have been tried in court. Before revoking had almost all the major manufacturers a Kava Kava product on the market, including Schwabe (Laitan) Lichtwer (Maoni) Krewel-Meuselbach (Antares), Harras (kavain) Kytta (Kytta-kava), Bionorica ( Kavatino) and Queisser (Jakava).
Source URL (retrieved on 18/06/2014 - 16:00): http://www.apotheke-adhoc.de/nachri...-koeln-widerruf-der-zulassung-fuer-kava-kava- rechtswidrig/
Copyright © 2007 - 2014, PHARMA ADHOC is a service provided by EL PATO Ltd.. - Agentur für Kommunikation. Skalitzer road 68/10997 Berlin Managing Director: Patrick Hollstein, Elke Hinkelbein / Amtsgericht Berlin Charlottenburg / HRB 100 205 B / VAT Reg. DE246500697.