Recently, the State Food and Drug Administration issued a notice deciding to stop the production, sale and use of “Ducoxib” (generic name of Ametriazin Robaxin Tablets, also known as compound Ametriazin Tablets) in China, and revoke its approval documents. The notice requires the provinces (autonomous regions and municipalities) Food and Drug Administration to immediately notify the above decision within the jurisdiction of the relevant drug production, operation and use of units to comply with the implementation. Almitraz Robaxin Tablets (compound almitraz tablets) have been produced by the local food and drug supervision and management departments to supervise the destruction or disposal.
Almitraz Robaxin Tablets, also known as compound almitraz tablets, for vasodilators. In August 1988, the French company Schweizer obtained the first import license for Almitraz Robaxin Tablets in China, under the trade name of Ducoxib. Ltd. was approved for domestic production in May 2005. At present, China also has Nanyang Pu Kang Group Heng U Pharmaceutical Co., Ltd. and Changzhou Pharmaceutical Co., Ltd. two enterprises to produce amytriazine Robaxin tablets.
Previously, in accordance with the requirements of the State Food and Drug Administration, Schweizer (Tianjin) Pharmaceutical Company conducted a clinical study using new effectiveness evaluation criteria to re-evaluate the clinical effectiveness of amytriazine lorazepam tablets. The results of the study showed no statistical difference between the dosing group and the placebo group. The study failed to conclude that almitraz robaxin tablets were more effective than placebo, and the clinical trial results did not support that taking almitraz robaxin tablets was effective in improving cognitive function in patients with non-demented vascular cognitive impairment.
In response to the results of the evaluation of the effectiveness study of Amethazine Robaxin Tablets, and in order to ensure the safety of public medication, and in accordance with Article 42 of the Drug Administration Law, the State Food and Drug Administration decided to stop the production, sale and use of Amethazine Robaxin Tablets (Compound Amethazine Tablets) in China and revoke its approval certificate document. Has been produced by the local drug supervision and management department to supervise the destruction or disposal of drugs.
The State Food and Drug Administration recommends that physicians explain to patients currently using Amethyst Rohypnol (Amethyst Rohypnol) Tablets so that patients can truly understand the clinical value of Amethyst Rohypnol Tablets, while helping patients seek appropriate alternative therapeutic measures. Patients who are currently using Ametanizine Robaxin Tablets are advised to seek prompt medical consultation and to consult with their physician for discontinuation and alternative treatment measures.
1. What kind of diseases are amytriazin Robaxin Tablets used to treat?
Almitriazine Robaxin Tablets, also known as compound almitriazine tablets, is a vasodilator. It is used for the treatment of symptoms related to cognitive and chronic sensory nerve damage in the elderly (excluding Alzheimer’s disease and other types of dementia); adjunctive treatment of vascular-derived visual impairment and visual field disorders; adjunctive treatment of vascular-derived hearing impairment, vertigo and/or tinnitus.
2.What is the marketing status of amytriazine lorazepam tablets in China?
In August 1988, the French company Schweizer obtained the first import license for amytriazine lorazepam tablets in China, under the trade name of Ducoxib, and in May 2005, Schweizer (Tianjin) Pharmaceutical Co. At present, in addition to Schweizer (Tianjin) Pharmaceutical Co., Ltd., there are Nanyang Pu Kang Group Heng U Pharmaceutical Co., Ltd. and Changzhou Pharmaceutical Factory Co.
3.Why do we need to re-evaluate the effectiveness of amytriazine lorazepam tablets?
The French Agency for Health Safety and Health Products (AFSSAPS) stopped the French marketing authorization of Amethyst Lopakhin because Svea failed to conduct clinical studies using the new effectiveness evaluation criteria requested by AFSSAFS to confirm the effectiveness of the drug.
Ltd. applied to the State Food and Drug Administration (SFDA) and expressed its willingness to conduct clinical studies in China according to the new efficacy criteria and to re-evaluate the efficacy of Amethyst Lopressor tablets, and obtained the consent of the SFDA.
4.What regulatory requirements did the State Food and Drug Administration put forward to the relevant manufacturing enterprises during the re-evaluation of Amethyst Robaxin Tablets?
In order to ensure the safety and effectiveness of drugs for the public, according to the Drug Administration Law and its implementing regulations, the State Food and Drug Administration requires the manufacturers of Ametanizine Robaxin Tablets to.
(1) within the validity of the drug approval number to carry out clinical studies to evaluate the effectiveness of amethystriazine lorazepam tablets. Clinical studies must use the new effectiveness evaluation criteria, and should strictly implement the “Drug Clinical Trial Quality Management Standards.
(2) Develop and take measures to strictly limit the clinical use of amytriazine lorazepam tablets, and control the scope of use within the scope of those who are already using the drug and whose continued use is deemed necessary by the physician, and not to expand to new users.
(3) Establish an effective information communication mechanism. Inform the public and clinical hospitals (physicians) of the efficacy and safety evaluation of the drug through effective channels.
(4) Key monitoring of adverse reactions to amethystriazine lorazepam tablets, and timely reporting of serious adverse reactions found.
5.What is the effectiveness study of Amethylline Robaxin Tablets? What is the evaluation result?
Ltd. conducted a clinical study between December 2008 and November 2009, and the study summary report was submitted to the State Food and Drug Administration in May 2010. The study adopted a multicenter, randomized, double-blind, parallel, placebo-controlled approach and actually enrolled 438 cases, including 222 cases in the Ducoxib trial group and 216 cases in the placebo group. The primary objective of the study was to demonstrate that amytriazine lorubicin tablets are effective in improving cognitive function in patients with non-dementing vascular cognitive impairment (VCIND) compared to placebo.
Ltd. submitted the clinical study report of Ametanizine Robaxin Tablets to the State Food and Drug Administration, the State Food and Drug Administration organized relevant experts to evaluate the effectiveness of the drug, and the evaluation concluded that: the study results showed no statistical difference between the medication group and the placebo group, the study failed to conclude that Ametanizine Robaxin Tablets were more effective than placebo, and the clinical trial results did not The results of the clinical trial do not support that taking amytriazine robaxin tablets can effectively improve the cognitive function of patients with non-dementia vascular cognitive impairment than taking placebo.
6.What measures have been taken by the State Food and Drug Administration for amethylline robaxin tablets?
In response to the evaluation results of the effectiveness study of Almitraz Robaxin Tablets, the State Food and Drug Administration decided to stop the production, sale and use of Almitraz Robaxin Tablets (Compound Almitraz Tablets) and revoke its approval number in order to ensure the safety and effectiveness of the drug for the public, in accordance with the Drug Administration Law.
7.What is the regulation of Amethyst Lopakhin Tablets in other countries?
After the first registration in France in 1978, Amethazine Robaxin Tablets manufactured by Schweiz AG have been marketed in 49 countries worldwide. After the withdrawal of Almitraz Robaxin tablets from the French market, the authorized countries where the drug was supplied by the French country of origin stopped selling Almitraz Robaxin tablets one after another. As of February 2011, only 15 countries in Asia, Central Asia and the Middle East maintained sales of Amethazine Robaxin Tablets worldwide, including: Bahrain, Egypt, Kuwait, Qatar, United Arab Emirates, Bangladesh, Pakistan, Hong Kong, China, Myanmar, Philippines, Singapore, Thailand, Vietnam, South Korea and China.
8.What is the impact of the withdrawal of Amethazine Robaxin Tablets on the treatment of patients in China?
The withdrawal of Ametanizine Robaxin Tablets will not have a negative impact on the medication of our patients.
First of all, the indication of Ametanizine Robaxin does not include dementia, so the withdrawal of Ametanizine Robaxin does not make it difficult for patients with dementia to obtain effective treatment drugs.
Second, the current medical consensus on mild cognitive impairment is that it refers specifically to older adults with mild memory or cognitive impairment but not to dementia. Mild cognitive impairment is used as a state of cognitive impairment between dementia and normal aging, and most pre-dementia experience mild cognitive impairment. The Canadian Consensus on the Diagnosis and Treatment of Dementia concludes that, given that there is insufficient evidence that cognitive interventions or pharmacological treatments are effective during the mild cognitive impairment stage, older adults should include physical activity as part of a healthy lifestyle.
9. What are the recommendations for doctors and patients?
After the withdrawal of almitraz robaxin tablets, physicians should explain to patients who are currently using almitraz robaxin tablets so that they can truly understand the clinical value of almitraz robaxin tablets and help them seek appropriate alternative treatment measures.
Patients who are currently using Ametanizine Robaxin Tablets should seek prompt medical attention and consult with their physician about discontinuation and alternative treatment measures.