List of APIs stopped granting registration number circulating in Vietnam

285
List of APIs stopped granting registration number
List of APIs stopped granting registration number circulating in Vietnam
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List of APIs stopped granting registration number circulating in Vietnam

SN APIs REGULATIONS CONTENT APPLIED TIME
1 Phenylbutazone The official letter 2706/QLD Stop granting new, renew registration numbers. Stop importing material, finished product containing Phenylbutazone. Stop manufacturing product containing Phenylbutazone granted registration numbers. 14-May-2001
2 Philatop Undefined Stop receiving new, renew dossiers Undefined
3 Opi extract Undefined Stop receiving new, renew dossiers Undefined
4 Chloramphenicol (Material powder packed in sachets) Undefined Stop receiving new, renew dossiers Undefined
5 Spartein sulfat Undefined Stop receiving new, renew dossiers Undefined
6 Vitamin A > 5.000 UI/tablet or > 2.500 UI/ml Undefined Stop receiving new, renew dossiers Undefined
7 Phenobarbital in combination with Paracetamol Undefined Stop receiving new, renew dossiers Undefined
8 Nimesulid The official letter 341/QLD-DK Stop receiving new, renew dossiers 9-Jan-2008
The official letter  3790/QLD-ĐK Continuing receving dossiers for external adminstrition 5-May-2008
9 Sibutramin The official letter 5678/QLD-ĐK Stop receiving new, renew dossiers 8-Jun-2010
10 Meprobamate pure form or combination with Valerian The official letter 5865/QLD-ĐK Stop receiving new, renew dossiers 24-Apr-2012
11 Aceprometazine pure form or combination with Clorazepate Undefined Stop receiving new, renew dossiers Undefined
12 Combined drug containing Acid acridon and N-Methylglucamin Undefined Stop receiving new, renew dossiers Undefined
13 Serratiopeptidase The official letter 5868/QLD-ĐK Stop importing, registration 24-Apr-2012
14 Ketoconazole oral rute The official letter 5869/QLD-ĐK Stop receiving new, renew dossiers 24-Apr-2012
15 Combined drugs containing APIs Streptokinase and Streptodornase The official letter 13702/QLD-ĐK Stop receiving imported licenses for combined drugs, and materials for purposes of producing above combinations 13-Sep-2012
The official letter 17499/QLD-KD Stop importing 13-Nov-2012
16 Combination Cefixim/Acid clavunanic; Ceftriazone/Sulbactam or similar combination between Cephalosporin and Beta-lactamase inhibitors (except Cefoperazone/Sulbactam) The official letter 13703/QLD-ĐK Stop receiving imported licenses for combined drugs, and materials for purposes of producing above combinations 13-Sep-2012
The official letter 17499/QLD-KD Stop importing 13-Nov-2012
17 Sodium hydrocarbonate pure form for oral administration with indication of antacid Undefined Stop granting new, renew registration numbers Undefined
18 Activated alpha drotrecogin Undefined Stop granting new, renew registration numbers Undefined
19 Duxil (Almitrin-Raubasin) The official letter 4398/QLD-ĐK Stop granting new, renew registration numbers 9-Apr-2012
The official letter 18428/QLD-ĐK
20 Pioglitazone The official letter 13707/QLD-ĐK Stop granting new, renew registration numbers 13-Sep-2012
21 Rosiglitazon The official letter 3886/QLD-ĐK Stop importing, registration
22 Buflomedil The official letter 12792/QLD-CL Suspend circulation and recall nationwide all products 27-Aug-2012
The official letter 13706/QLD-ĐK Stop importing, registration 13-Sep-2012
23 Medicines containing herbal component “thạch xương bồ” The official letter 14975/QLD-ĐK Stop granting new, renew registration numbers 2-Oct-2012
24 Medicines containing herbal component “biển súc” Undefined Request providing clinical documents Undefined
25 Oral administration drugs containing Artemisinin or derivatives of Artemisinin The decision 112/QĐ-QLD Withdraw registration numbers 20-May-2013
The official letter 7873/QLD-CL Stop using and recall nationwide 21-May-2013
26 BDD (biphenyl dimethyl dicarboxylat) or Bifendat The official letter 4822/QLD-ĐK Stop granting new, renew registration numbers. For valid registration numbers requested providing clinical documents. 31-Mar-2014
27 Cefetamet The official letter 4810/QLD-ĐK Stop granting new, renew registration numbers. For valid registration numbers requested providing clinical documents. 28-Mar-2014
28 Combined medicine containing Vitamins and  minerals for oral aministration The official letter 16751/QLD-ĐK Require to provide clinical studies for the combination drugs without providing origin of formula based on formal references or formulas, constituent granted registration numbers for circulation by references authories 29-Sep-2014
29 Metoclopramid The official letter 16752/QLD-ĐK Stop receiving new, renew registration dossiers, and do not grant registration numbers for drugs containing metoclopramide with dosage forms and routes of administration as recommended by the EMA, in particular: – The liquid medicine for oral in children have larger concentrations of 1 mg/ml – Preparations for intravenous have larger concentration of 5mg/ml – Rectal administration preparations doses of 20mg. 29-Sep-2014
30 Gatifloxacin The decision 101/QD-QLD Withdraw registration numbers 14-Feb-2015
31 Tetrazepam The official letter 5078/QLD-ĐK Stop importing, registration, circulation 20-Mar-2015
32 Lysozym The official letter 1209/QLD-CL Suspend circulation and recall nationwide all products containing Lysozym 23-Jan-2015
The official letter 5131/QLD_CL Suspend circulation and recall nationwide all products containing Lysozym 23-Mar-2015
33 Biphenyl dimethyl dicarboxylat, Cefetamet The decision 442/QD-QLD Withdraw registration numbers, suspend circulation, recall nationwide all nationwideproducts containing APIs Biphenyl dimethyl dicarboxylat, Cefetamet 10-Aug-2015

 

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