List of APIs stopped granting registration number circulating in Vietnam

Cập nhật lần cuối2018-04-20 11:32 UTC+7

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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
8	Nimesulid	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
15		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
16		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
19	Duxil (Almitrin-Raubasin)	The official letter 18428/QLD-ĐK	Stop granting new, renew registration numbers	9-Apr-2012
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
22	Buflomedil	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
25		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
32	Lysozym	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