Conversely, bupropion withdrawal ADRs were here reported in 299/20,720 (1.44%) cases and in 914/47,516 (1.92%) cases for venlafaxine (see Tables The total number of ADRs corresponded to 264 and 447 patients respectively prescribed with bupropion (Jan 2005-May 2016) and venlafaxine (June 2003-July 2016).Over time, both bupropion and venlafaxine reports were on the increase (Figure To better compare bupropion and venlafaxine addictive liability levels, the PRR values were computed for each ADR class (e.g., drug misuse/abuse; dependence; and withdrawal). For this reason, report duplications may occur indeed, e.g., where a healthcare professional reported the same suspected ADR to both the national regulator and the Marketing Authorization Holder, and both eventually reported the index ADR to the EV. 2003 Jun;22(2):203-20. doi: 10.1080/09595230100100642.Eur J Clin Pharmacol.
Results In median, for a sample of 24 cancer medicines that obtained marketing authorization between 2010 and 2014, the expected time from EU-wide marketing authorization to … 4. 2020 Jul;10(1):14-26. doi: 10.1038/s41367-020-0015-3. It is an effective antidepressant on its own, but it is also used as an add-on medication in cases of incomplete response to first-line SSRI antidepressants. University of Texas Southwestern Medical Center, United States 2016 Dec 6;188(17-18):E484-E492. In fact, whilst English PCA data confirmed venlafaxine increase in prescribing levels in the 2009–2016 time frame, an opposite trend was identified for bupropion. doi: 10.2165/00002018-200831110-00006.
Marketing Authorisation Holder. JUST/2013/DPIP/AG/4823, EU-MADNESS project). The EudraGMDP database is maintained and operated by the EMA. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State.
QUALITY ASPECTS II.1 Introduction Bupropion HCl Sandoz retard 150 mg is a white to pale yellow, round, biconvex tablet, plain on both sides. Name must be less than 100 characters Bupropion HCl Sandoz retard 300 mg is a white to pale yellow, biconvex tablet, printed with ‘A 152’ on
Supplementary II. Although, for a range of reasons, the worldwide prescription figures for these molecules are not available (To assess both venlafaxine and bupropion misuse/abuse/dependence and withdrawal-related issues, we aimed here at analyzing the European Medicines Agency (EMA) EudraVigilance (EV) database (After a formal request to EMA, we were allowed to access and analyze the EV ADRs database, relating to all venlafaxine- and bupropion-related case reports submitted spontaneously up to mid-July 2016; for a thorough description of the EV database refer to ADRs' numbers differed from those referring to case reports, since different reporters/senders could have independently flagged the same ADR to EMA.
Manufacturing and Importation Authorisations are to be entered into EudraGMDP, as referred to in Art. TYPES OF MARKETING AUTHORIZATION APPLICATIONS Legal types of marketing authorizations are provided Table 4. As it appears from the following calculation, misuse/abuse ADRs appeared to be more frequently reported for bupropion than venlafaxine:Conversely, PRR values for dependence and withdrawal resulted to be respectively 0.92 and 0.77, meaning that these ADRs were more frequently represented in venlafaxine-, as opposed to bupropion-, related reports (for all computations, see Table According to the MHRA Yellow card Scheme, the number of paroxetine, venlafaxine, fluoxetine and bupropion withdrawal-related ADRs resulted to be as follows: paroxetine: 1,358 reports out of a total number of 18,988 (7.1%); venlafaxine: 471/11,350 (4.2%); fluoxetine: 74/7,905 (0.93%); bupropion: 30/20,585 (0.14%; Table This study aimed at systematically identifying and analyzing venlafaxine-, as opposed to bupropion-, misuse/abuse/dependence and withdrawal issues.
Springer
marketing authorisation holder's contact email address and telephone number for pharmacovigilance enquiries.
The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC.
If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. Indeed, this may suggest the comorbid presence of depression with substance misuse conditions.
First step to a solution: EMA changes its policy.
EMA updates this document periodically to reflect changes in the Article 57 database.
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