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AA Tra NDC 64784-730-07 Tamper-evident Do not accept it seal over boe p s broken or missing Store at 25C ersions permthed NDC E4764-730-07 Tamper evident D n ace er bottle opening is broken or miing Strce 2C (77 en to 15-30 C 0- P Controe Tamper-evident Do not accept if seal over bottle opening is broken or missing Store at 25 C (77°F, excursions permitted to 15-30°C (59-B5 F) (see USP Controlled Room Temperature). Titelix spermited bottle cpen NDC 64764-730-07 Pom Temperaure Upusl DgS Usual Dosage: See package insert nal Sample-Not for Salo Sale Do not acceptiseal over seal ing SempleNot for Sale mple- over roken ge: See package inser nsert permit eXCursions permitted htes cent to 10 ma vo roken ormi l over e porkag insert ted 9877 ns permit hydrobron contains e hydrobromide onal Samplo Not for Sale boe epios taccept if sal over ntin Protes Menalo onal Sample-Not for Sale tovident: Do not accentf seat Over sge See package insert U broken or missing t ge: See package insert S1at 25 Dexcursions perm 9-86 Only Renor missing 2 71 ma vortablet contains valont to 10e hydrobrom 25 C(77 );excursions permitted Termperae7 s00 US USP Contro onal Sample-Not for Sale mg worthouetine fydrobramide Do not accent if seal Over ng o tcontains vortioxetine). abroken or missing See package insert. eepner 25C77Pexcursions permitted USP sture alet contains orieine tudrobromide Phamaceuticals America, by Lupd G0015 NTELLIXa trademark h th ndbeck A/S registered eand Fah and Mktd. ty en and r akn armaceuicals America Fokada L373-02 -Nt for Sale seal over U permitted Controll OF DENMARK 25568 017276 me-Not for AAcc ckge unions 895 0 34 0(2 22 (0 07 3448 27( tcay stay nmnt o intiammation and toyperglaand p yos he finding did not Oin male rats at 20 imes the MRD 319(4 1 onstrated in fe 6 to 8w LLIX 5 m 10 mg 15 mg or e final doses were red up fr chem ur HAMD-24) total sore in Stady cach of these stdies, at least o easured by mean change tron b gender or race did not sogpest y n Table 4) failed to show ellective 12 and 24 mes, respectivy 267924 101 y (Ames tet), an in vitro d assay rn rndmd doube bnd h MDD (Suy Tble Pae sode belore De ge of 60 years asd wi LX 5 g or pacebo ct on male o 017276 W AS2 Mean Bazeline Score (SD) enare LS M Change 8aseline 34.1(2.6) 20 4 (1.0) 34.0(2.8) 202 (1.0 33.9 (2.7) 67(-85 2 vityp 145 (1.0 322 (5.0 pharmacokinetics ta mean terminal half- Ping 15A (97) 41 S reached tia20 m 20(44 91-70-29 Jera 62, 21) i a cyto cackd con arboxylic a meta bolizer y 59% and A pep stafisticay sin ted to infan AUdy The g TRINTELL (vortioxetine) 12 nasay olu ASSay nO effect 32 rmacokinetics of vortioxetine (2.5 mg to 60 m)are Inea and an terminal hall-life is approximately 66 hours, and steady-state 32 835ST s 6 to 8w e stuaty in 3 ached within ng/day. Ab star rats were given oral doses of vor /kg/day for male and female rats, resper respectively, the maximum recommen statistically significantly increased in tu ed to inflammation and hyperplasia an y The finding did not occur in male rats 4162 29.2 ( PRCD OF DENMARK 3 LOT P25568 017276 UR rON INT the final dses efm iythe fs TELLIX 5 mg 10mr 15 mg or 20g or s o Amonstrated in five 6 to 8week placeo-contoled suties(Sues nonst ears) e episod NTELLIX S study in adult inpatients and outpatients who met the Diegnostic x6 to 8 week randomized, double-blind, placebo-cotrallet, Mea Baselin Score (SD als ts 34.1(2.6) effect on male or fermale fertlity,which is 58 fim the maiu 34.0(2.8) 33.9(2.7) 71DALI 1 assay(Ames test),an in vitro chromosome aeration assay in 322(5

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AA Tra NDC 64784-730-07 Tamper-evident Do not accept it seal over boe p s broken or missing Store at 25C ersions permthed NDC E4764-730-07 Tamper evident D n ace er bottle opening is broken or miing Strce 2C (77 en to 15-30 C 0- P Controe Tamper-evident Do not accept if seal over bottle opening is broken or missing Store at 25 C (77°F, excursions permitted to 15-30°C (59-B5 F) (see USP Controlled Room Temperature). Titelix spermited bottle cpen NDC 64764-730-07 Pom Temperaure Upusl DgS Usual Dosage: See package insert nal Sample-Not for Salo Sale Do not acceptiseal over seal ing SempleNot for Sale mple- over roken ge: See package inser nsert permit eXCursions permitted htes cent to 10 ma vo roken ormi l over e porkag insert ted 9877 ns permit hydrobron contains e hydrobromide onal Samplo Not for Sale boe epios taccept if sal over ntin Protes Menalo onal Sample-Not for Sale tovident: Do not accentf seat Over sge See package insert U broken or missing t ge: See package insert S1at 25 Dexcursions perm 9-86 Only Renor missing 2 71 ma vortablet contains valont to 10e hydrobrom 25 C(77 );excursions permitted Termperae7 s00 US USP Contro onal Sample-Not for Sale mg worthouetine fydrobramide Do not accent if seal Over ng o tcontains vortioxetine). abroken or missing See package insert. eepner 25C77Pexcursions permitted USP sture alet contains orieine tudrobromide Phamaceuticals America, by Lupd G0015 NTELLIXa trademark h th ndbeck A/S registered eand Fah and Mktd. ty en and r akn armaceuicals America Fokada L373-02 -Nt for Sale seal over U permitted Controll OF DENMARK 25568 017276 me-Not for AAcc ckge unions 895 0 34 0(2 22 (0 07 3448 27( tcay stay nmnt o intiammation and toyperglaand p yos he finding did not Oin male rats at 20 imes the MRD 319(4 1 onstrated in fe 6 to 8w LLIX 5 m 10 mg 15 mg or e final doses were red up fr chem ur HAMD-24) total sore in Stady cach of these stdies, at least o easured by mean change tron b gender or race did not sogpest y n Table 4) failed to show ellective 12 and 24 mes, respectivy 267924 101 y (Ames tet), an in vitro d assay rn rndmd doube bnd h MDD (Suy Tble Pae sode belore De ge of 60 years asd wi LX 5 g or pacebo ct on male o 017276 W AS2 Mean Bazeline Score (SD) enare LS M Change 8aseline 34.1(2.6) 20 4 (1.0) 34.0(2.8) 202 (1.0 33.9 (2.7) 67(-85 2 vityp 145 (1.0 322 (5.0 pharmacokinetics ta mean terminal half- Ping 15A (97) 41 S reached tia20 m 20(44 91-70-29 Jera 62, 21) i a cyto cackd con arboxylic a meta bolizer y 59% and A pep stafisticay sin ted to infan AUdy The g TRINTELL (vortioxetine) 12 nasay olu ASSay nO effect 32 rmacokinetics of vortioxetine (2.5 mg to 60 m)are Inea and an terminal hall-life is approximately 66 hours, and steady-state 32 835ST s 6 to 8w e stuaty in 3 ached within ng/day. Ab star rats were given oral doses of vor /kg/day for male and female rats, resper respectively, the maximum recommen statistically significantly increased in tu ed to inflammation and hyperplasia an y The finding did not occur in male rats 4162 29.2 ( PRCD OF DENMARK 3 LOT P25568 017276 UR rON INT the final dses efm iythe fs TELLIX 5 mg 10mr 15 mg or 20g or s o Amonstrated in five 6 to 8week placeo-contoled suties(Sues nonst ears) e episod NTELLIX S study in adult inpatients and outpatients who met the Diegnostic x6 to 8 week randomized, double-blind, placebo-cotrallet, Mea Baselin Score (SD als ts 34.1(2.6) effect on male or fermale fertlity,which is 58 fim the maiu 34.0(2.8) 33.9(2.7) 71DALI 1 assay(Ames test),an in vitro chromosome aeration assay in 322(5

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