ȆȇȅȉǹȈǾ ȅȂǹǻȅȆȅǿǾȈǾȈ Ȃȅȇĭȍȃ ĭǹȇȂǹȀȍȃ ǺǹȈǼǿ ȉǾȈ ȉȊȆȅȆȅǿǾȂǼȃǾȈ ȅȇȅȁȅīǿǹȈ (STANDARD TERMS) ȉȅȊ EDQM ȂǼ ȉǿȈ ȈȊȃȉȂǾȈǼǿȈ ȉȅȊȈ ȅȆȍȈ ǹȃǹĭǼȇȅȃȉǹǿ Ȉȉǹ ǹȇȋǼǿǹ ȉȅȊ Ǽȅĭ ȂǼȉǹ ȉǿȈ ȆǹȇǹȉǾȇǾȈǼǿȈ ȉȅȊ ȉȂǾȂǹȉȅȈ ĭǹȇȂǹȀȍȃ ȉǾȈ ǻ/ȃȈǾȈ ǺǿȅȂǾȋǹȃǿȀȍȃ ȆȇȅȎȅȃȉȍȃ Ȁǹǿ ĭǹȇȂǹȀȍȃ 10-6-2010 1 1.1 2 2.1 2.2 2.3 2.4 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 4 4.1 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 6 6.1 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.11 8.12 8.13 8.14 8.15 9 9.1 9.2 10 10.1 10.2 10.3 ǹȚȝȠıIJĮIJȚțȠȓ ıʌȩȖȖȠȚ (ȖȚĮ ȤİȚȡȠȣȡȖȚțȒ ȤȡȒıȘ - IJȠʌȚțȫȢ įȡȫȞIJĮ) MED.SPONG ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (İȚıʌȞȠȑȢ) INHALAT INH.PD.DOS INHPD.CAP PD.INH.MD ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ıIJİȡİȑȢ ȝȠȡijȑȢ IJȡȠʌȠʌȠȚȘȝȑȞȘȢ ĮʌȠįȑıȝİȣıȘȢ) CO.R.F.C.T CO.R.S.C.T CON.R.TAB CR.GRAN MOD.R.CA.H PR.CAP PR.TAB S.R.F.C.TA SR.TAB ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ Ȓ ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ IJȡȠʌȠʌȠȚȘȝȑȞȘȢ ĮʌȠįȑıȝİȣıȘȢ) GR.GR.SUS ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ıIJİȡİȑȢ ȝȠȡijȑȢ IJȡȠʌȠʌȠȚȘȝȑȞȘȢ ĮʌȠįȑıȝİȣıȘȢ ȖĮıIJȡȠĮȞșİțIJȚțȑȢ/İȞIJİȡȠįȚĮȜȣIJȑȢ ) E.C.CAPS E.C.TAB E.F.C.TAB E.S.C.TAB GR.CAP GR.PR.GRA GR.PR.R.TA ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ Ȓ ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ IJȡȠʌȠʌȠȚȘȝȑȞȘȢ ĮʌȠįȑıȝİȣıȘȢ ȖĮıIJȡȠĮȞșİțIJȚțȑȢ/İȞIJİȡȠįȚĮȜȣIJȑȢ ) GR.PR.O.SU ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ Ȓ ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) GRA.OR.SOL GRA.OR.SUS PD.ORA.SOL PD.ORA.SUS PD.SOL.SD PS.OR.SOL PS.OR.SUS PD.OR.D SOLU.TAB DISP.TAB HERBAL. TEA ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ıIJİȡİȑȢ ȝȠȡijȑȢ) C.TAB F.C.TAB CAPS CHEW.GUM CHW.TAB OR.DISP.TA PD.OR.SD SOFT.CAPS TAB TOF DIS/CH.TAB GR.OR.SD TA/DISP.TA GRANULES ORAL.PD ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ĮȞĮȕȡȐȗȠȣıİȢ ȝȠȡijȑȢ) EF.TAB EFF.GRAN ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ ȖȚĮ İȚıʌȞȠȑȢ) AER.MD.INH INH.NE.SOL INH.NE.SU 10.4 10.5 10.6 10.7 10.8 10.9 10.10 INH.SOL.N INH.SOL.P INH.SUS.N INH.SUS.P INH.VAP.LI VO.LIQ.G.A INH.NE.SU 11 ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ Ȓ/țĮȚ ȡȚȞȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ ȖȚĮ İȚıʌȞȠȑȢ) 11.1 SOL.INH (ȑȞĮ ȝȠȞĮįȚțȩ ʌȡȠȧȩȞ LOCABIOTAL) 12 ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) 12.1 ELIX 12.2 OIL.ORAL 12.3 OIL.SOL.OR 12.4 OR.SO.D 12.5 OR.SOL.SD 12.6 OR.SU.D 12.7 ORAL.EMUL 12.8 ORAL.SOL 12.9 ORAL.SUSP 12.10 SOLUT 12.11 SYR 12.12 SUS.SD 13 ǹʌȩ IJȠȣ ıIJȩȝĮIJȠȢ ȤȠȡȒȖȘıȘ Ȓ/țĮȚ Įʌȩ IJȠ Ƞȡșȩ (ȣȖȡȑȢ ȝȠȡijȑȢ) 13.1 SOL.OR/REC 14 ǻİȡȝĮIJȚțȒ İijĮȡȝȠȖȒ (ȜȠȚʌȑȢ ȝȠȡijȑȢ) 14.1 CORN.PAD 14.2 IMP.GAUZE 14.3 MED.PLAST 14.4 FOAM 14.5 AER.TOP 15 ǻİȡȝĮIJȚțȒ İijĮȡȝȠȖȒ (ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) 15.1 CR.EXT.US 15.2 CREAM 15.3 EMUL.EXT.U 15.4 EMULGEL 15.5 GEL 15.6 GEL.EXT.US 15.7 OINT.EXT.U 15.8 OINTMENT 16 ǻİȡȝĮIJȚțȒ İijĮȡȝȠȖȒ (ıIJİȡİȑȢ ȝȠȡijȑȢ țĮȚ ıȐʌȦȞİȢ) 16.1 MED.L.SOAP 16.2 MED.SHAMP 16.3 PD.EXT.US 16.4 CUT.SP.PD 17 ǻİȡȝĮIJȚțȒ İijĮȡȝȠȖȒ (ȣȖȡȑȢ ȝȠȡijȑȢ) 17.1 CUT.SOL 17.2 LOT 17.3 NAIL.LAQU 17.4 SOL.EXT.US 17.5 SPR 17.6 SPR.SOL 17.7 TINCT 17.8 VL.S.TA 18 ǻȚĮįİȡȝȚțȒ ȤȠȡȒȖȘıȘ 18.1 TTS 19 ǼȝijȪIJİȣȝĮ 19.1 PD.SUS.IM 19.2 IMPLANT 19.3 INJ.IMPL 20 ǼȞįȠțȣıIJȚțȒ ȑȖȤȣıȘ 20.1 LP.INVES.L 20.2 P.S.INTVES 20.3 PD.BLAD.IR 21 ǼȞįȠȝȒIJȡȚĮ ȤȠȡȒȖȘıȘ (ıȪıIJȘȝĮ İȞįȠȝȒIJȡȚĮȢ ȤȠȡȒȖȘıȘȢ) 21.1 INTRAUT.DE 22 ǼȞįȠIJȡĮȤİȚȠʌȞİȣȝȠȞȚțȒ ȤȠȡȒȖȘıȘ 22.1 SUS.TR.INS 22.2 SUSP.TRACH 23 ǼȞįȠijșȐȜȝȚĮ ȤȠȡȒȖȘıȘ (ȑȞİıȘ Ȓ ȑȖȤȣıȘ) 23.1 LY.P.EY.DR 24 24.1 24.2 24.3 24.4 25 25.1 25.2 26 26.1 27 27.1 27.2 27.3 27.4 27.5 27.6 28 28.1 28.2 28.3 29 29.1 29.2 29.3 30 30.1 30.2 30.3 30.4 31 31.1 31.2 32 32.1 32.2 32.3 32.4 32.5 32.6 32.7 33 33.1 33.2 34 34.1 35 35.1 ȀȠȜʌȚțȒ ȤȠȡȒȖȘıȘ (ȘȝȚıIJİȡİȑȢ țĮȚ ıIJİȡİȑȢ ȝȠȡijȑȢ) VAG.CR VAG.GEL VAG.SUP VAG.TAB ȀȠȜʌȚțȒ ȤȠȡȒȖȘıȘ (ıȪıIJȘȝĮ țȠȜʌȚțȒȢ ȤȠȡȒȖȘıȘȢ) VAG.DEVICE VAG.SYST ȀȠȜʌȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) VAG.SOL ȁȠȚʌȑȢ ȝȠȡijȑȢ BEAD.SU.WI IMP.CO.COT TIS.AD.LIQ URET.STICK ENT.GEL GENER.RN ȅįȠȞIJȚțȒ ȤȡȒıȘ DENT.INS DENTAL.SUS TOOTHPASTE ȅȡșȚțȒ ȤȠȡȒȖȘıȘ (ȘȝȚıIJİȡİȑȢ Ȓ ıIJİȡİȑȢ ȝȠȡijȑȢ) OINT.REC.A RECT.CREAM SUPP ȅȡșȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) ENEMA REC.SOL REC.SUS REC.FOAM ȅijșĮȜȝȚțȒ ȤȠȡȒȖȘıȘ (ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) EYE.GEL EYE.OINT ȅijșĮȜȝȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) EY.DR.S.SD EY.DRO.SOL EY.DRO.SUS EY.SOL.SD LY.P.EY.DR S.IR.SO TAB.EY.DRO ȅijșĮȜȝȚțȒ-ȦIJȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) EA.EY.SOL EY.EA.D.SO ȅijșĮȜȝȚțȒ-ȡȚȞȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) EY.NAS.SOL ȆĮȡİȞIJİȡȚțȒ ȤȠȡȒȖȘıȘ (ȑȞİıȘ Ȓ ȑȖȤȣıȘ ʌĮȡĮIJİIJĮȝȑȞȘȢ įȡȐıȘȢ) OILY.INJ ANABOLINE DEPOT (Nandrolone Decanoate) DECA DURABOLIN (Nandrolone Decanoate) NANDROLONE DECANOATE/NORMA (Nandrolone Decanoate) EXTRABOLINE (Nandrolone Decanoate) TESTOSTERONE ENANTATE/NORMA (Testosterone Enantate) TESTOVIRON (Testosterone Enantate) ANDROCUR (Cyproterone Acetate) CLOPIXOL (Zuclopenthixol Decanoate) 35.2 INJ.SOL SOMATULINE AUTOGEL (Lanreotide Acetate) ALOPERIDIN (Haloperidol Decanoate) 35.3 PD.S.IN.SR GONAPEPTYL DEPOT (Triptorelin) 35.4 PD.S.IN.PR ZYPADHERA (OLANZAPINE) RISPERDAL CONSTA (Risperidone) 35.5 PS.INJ.SUS SANDOSTATIN LAR (Octreotide Acetate) SOMATULINE (Lanreotide Acetate) DARONDA DEPOT (Leuprorelin Acetate) ELITYRAN (Leuprorelin Acetate) ARVEKAP (Triptorelin) 35.6 INJ.SU.RET CELESTONE CHRONODOSE (Betamethasone Acetate+Betamethasone Sodium Phosphate) 35.7 PS.INJ.SOL CETROTIDE (Cetrorelix Acetate) 35.8 INJ.SUSP PROPIOCHRONE (Betamethasone Dipropionate+Betamethasone Sodium Phosphate) 36 36.1 36.2 36.3 36.4 36.5 36.6 36.7 36.8 36.9 36.10 36.11 36.12 36.13 36.14 36.15 36.16 36.17 36.18 36.19 36.20 36.21 36.22 36.23 36.24 36.25 36.26 36.27 36.28 36.29 36.30 36.31 36.32 36.33 36.34 36.35 37 37.1 37.2 38 38.1 39 39.1 39.2 40 40.1 40.2 40.3 40.4 40.5 40.6 40.7 41 41.1 41.2 41.3 41.4 41.5 41.6 41.7 41.8 42 42.1 ȆĮȡİȞIJİȡȚțȒ ȤȠȡȒȖȘıȘ (ȑȞİıȘ Ȓ ȑȖȤȣıȘ) C.DI.S.INF C/S.SOL.IN CS.INJ.SOL DR.PD.INJ IN.CO.S.PS IN.SO.CR IN.SO.PF.P INJ.EM.IN INJ.EM.INF INJ.SO.INF INJ.SO.PFS INJ.SU.PFS INJ.SOL INJ.SUSP OILY.INJ P.S.C.S.IF P.SV.INJ.F PD.C.SO.IN PD.CSO.J.F PD.I.S.INF PD.INJ.SOL PD.PM.C.LI PD.SOL.INF PDC.S.S.IF PD.I.SO.SU PD.SU.IN.S PD.SUS.IM PS.INJ.SOL PS.INJ.SUS PS.SOL.INF SO.INJ.INF SOL.INF SOL.IV.INF SOLV.INJ SOLV.PA.IN ȆĮȡİȞIJİȡȚțȒ ȤȠȡȒȖȘıȘ (ȜȣȩijȚȜĮ) LY.P.IV.IN LY.PD.INJ ǻȚĮȜȪȝĮIJĮ ĮȚȝȠțȐșĮȡıȘȢ SOL.HAEMDF ȇȚȞȚțȒ ȤȠȡȒȖȘıȘ (ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) NAS.GEL NAS.OINT ȇȚȞȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) M.D.NAS.SP N.SP.SU.MD NAS.SOL NAS.SPR NASDR.SUS NASPR.SOL NASPR.SUS ȂȠȡijȑȢ ʌȠȣ įȡȠȣȞ ıIJȠ ıIJȠȝĮIJȚțȩ ȕȜİȞȞȠȖȩȞȠ (ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) GEL GEL.OR.TOP GEL.ORAL MOUTH.PAST LING.TAB SUBL.TAB LOZ OR.T.OINT ȂȠȡijȑȢ ʌȠȣ įȡȠȣȞ ıIJȠ ıIJȠȝĮIJȚțȩ ȕȜİȞȞȠȖȩȞȠ (ȣȖȡȑȢ ȝȠȡijȑȢ) MOUTH SPR 42.2 42.3 42.4 42.5 42.6 43 43.1 43.2 43.3 44 45 46 MOUTH.WASH OR.T.SOL SOL.GA.M.W GARGLE SPR ȍIJȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ) EA.SOL EAR.SO.S.D MD.EA.SPR ȅijșĮȜȝȚțȒ - ȦIJȚțȒ ȤȠȡȒȖȘıȘȢ (ȘȝȚıIJİȡİȑȢ ȝȠȡijȑȢ) ȅijșĮȜȝȚțȒ ȤȠȡȒȖȘıȘ ʌĮȡĮIJİIJĮȝȑȞȘȢ įȡȐıȘȢ (ȣȖȡȑȢ ȝȠȡijȑȢ) ȅijșĮȜȝȚțȒ-ȦIJȚțȒ-ȡȚȞȚțȒ ȤȠȡȒȖȘıȘ (ȣȖȡȑȢ ȝȠȡijȑȢ)
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