AGENCIA NACIONAL DE REFERENCIA REGIONAL DIRECCIÓN DE MEDICAMENTOS Y PRODUCTOS BIOLÓGICOS FUNCIÓN REGULADORA PUBLICACIÓN FECHA DE PUBLICACIÓN Laboratorio y Liberación de Lotes- Oficina de Laboratorios y Control de Calidad Liberación de lotes de Vacunas y Hemoderivados realizadas en Diciembre de 2015 2015-12-12 Distribuidor o remitente del producto Nombre del Producto Presentación Productor Fecha de vencimiento No. lote del producto Total de unidades distribuidas en el país Fecha de Concepto de calidad del LPB Certificado de Liberación INTRATECT x 50mL 50mL BIOTEST PHARMA GMBH 2017-05-31 B791685 500 2015-12-15 PR-2488 FACTOR HUMANO ANTIHEMOFILICO METODO M HEMOFIL M 10mL BAXTER HEALTHCARE CORPORATION 2017-06-21 THA14270AA 4300 2015-12-09 PR-2501 VACUNA (PENTAVALENTE) DPT- HEP B-HIB 0,5mL Serum Institute of India 2017-02 137Q5007D 3300 2015-12-10 FR-2535 KIOVIG 1g 10mL BAXTER S.A 2017-04 LE12Q171AJ 85 2015-12-10 PR-2542 GlaxoSmithKline Colombia S.A. SYNFLORIX 0,5mL GlaxoSmithKline Biologicals S.A. 2017-03 ASPNA598BJ 400 2015-12-10 PR-2545 IMMUNATE 500 UI 5mL BAXTER A.G. 2017-05 VNC3Q049AG 820 2015-12-09 PR-2546 IMMUNATE 250 UI 5mL BAXTER A.G. 2017-06 VNC3Q054AB 270 2015-12-09 PR-2547-R1 VACUNA ANTITETANICA 0,5mL INSTITUTO FINLAY 2016-12 4095T 24520 2015-12-23 PR-2554 IMMUNATE 250 UI 5mL BAXTER A.G. 2017-06 VNC3Q054AB 360 2015-12-10 PR-2560 PENTAGLOBIN 100mL BIOTEST PHARMA GMBH 2017-06-30 B136155 600 2015-12-15 PR-2562 GlaxoSmithKline Colombia S.A. PRIORIX 0,5mL GlaxoSmithKline Biologicals S.A. 2017-06 A69CE074A 1560 2015-12-16 PR-2564 NOVARTIS DE COLOMBIA S.A. MENVEO 0,5mL Novartis Vaccines and Diagnostic S.r.l 2017-05 M15096 20022 2015-12-18 PR-2568 MEGALOTECT CP 10mL CSL Behring GmbH 2018-04-30 B797065 30 2015-12-10 PR-2571 LABORATORIOS BIOPAS S.A. WILFACTIN 1000 UI 10mL LFB BIOMEDICAMENTS 2017-05 15L08649 214 2015-12-10 PR-2572 PFIZER S.A.S PREVENAR 13 VALENTE 0,5mL Pfizer Ireland Pharmaceuticals 2018-04 M40873 9960 2015-12-18 PR-2577 GARDASIL 0,5mL Merck Sharp & Dohme Corp. 2016-10-30 K001865 15000 2015-12-23 FR-2590 VACUNA ANTITETANICA 0,5mL INSTITUTO FINLAY 2017-05 5022T 22973 2015-12-09 PR-2593 GlaxoSmithKline Colombia S.A. ENGERIX B 1mL GlaxoSmithKline Biologicals S.A. 2018-04 AHBVC514BC 5760 2015-12-23 PR-2607
VACUNA BCG 0,5mL Serum Institute of India 2016-12 037G4278 261410 2015-12-09 FR-2608 BIOTOSCANA RHOPHYLAC 300 mcg 2mL CSL Behring GmbH 2017-11 4345900016 600 2015-12-15 PR-2609 ROTARIX 1,5mL GlaxoSmithKline Biologicals S.A. 2017-08-31 AROLB255AA 246160 2015-12-23 FR-2613 TETADIF (VACUNA Td) 5mL BB - NCIPD Ltd. 2018-01 D2264 2200 2015-12-09 FR-2625 NISSI S.A.S OCTANINE 250 UI 5mL 2018-06 A530A2201 20 2015-12-09 PR-2626 VACUNA DT (TETADIF) 5mL BB - NCIPD Ltd. 2018-03 D2272 172800 2015-12-09 FR-2628 VACUNA DT (TETADIF) 5mL BB - NCIPD Ltd. 2018-03 D2273 38400 2015-12-09 FR-2629
SANOFI PASTEUR S.A STAMARIL 0,5mL SANOFI PASTEUR S.A 2017-12 M5025-6 22400 2015-12-09 PR-2630 GlaxoSmithKline Colombia S.A. TWINRIX 1mL GlaxoSmithKline Biologicals S.A. 2018-03 AHABB343AA 7780 2015-12-09 PR-2632 BIOTOSCANA FARMA S.A. SANDOGLOBULINA 6g 250mL CSL Behring GmbH 2018-06-30 4340200141 3000 2015-12-09 PR-2634 IMMUNATE 1000 UI 10mL BAXTER A.G. 2017-02 VNC3Q027AA 675 2015-12-09 PR-2636 FEIBA 1000 U 20mL BAXTER A.G. 2017-05 VNF2Q052AC 720 2015-12-09 PR-2637 GAMMARAAS 100mL 2018-05-29 201505G009-1 2780 2015-12-09 PR-2638 GAMMARAAS 100mL 2017-10-03 201410G014 220 2015-12-09 PR-2639-R1 VACUNA ANTITETANICA 0,5mL INSTITUTO FINLAY 2017-05 5023TX 21237 2015-12-09 PR-2641 GlaxoSmithKline Colombia S.A. INFANRIX HEXA 0,5mL GlaxoSmithKline Biologicals S.A. 2017-09 A21CC597A 11700 2015-12-09 PR-2642 FEIBA 500 U 20mL BAXTER A.G. 2017-07 VNF2Q064AP 1296 2015-12-09 PR-2644 IMMUNATE 500 UI 5mL BAXTER A.G. 2017-06 VNC3Q055AC 675 2015-12-09 PR-2645 IMMUNATE 1000 UI 10mL BAXTER A.G. 2017-01 VNC3Q012AC 1215 2015-12-09 PR-2646 IMMUNATE 500 UI 5mL BAXTER A.G. 2017-07 VNC3Q070AE 325 2015-12-09 PR-2647 IMMUNINE 600 UI 5mL BAXTER A.G. 2017-08 VNC1Q024AB 1782 2015-12-09 PR-2648 KIOVIG 10g 100mL BAXTER S.A 2017-08 LE12Q262AH 1172 2015-12-10 PR-2651 ALBUMINA HUMANA 20% 50mL BIOTEST A.G 2018-08-31 B235295 9844 2015-12-10 PR-2653 ALBUMINA HUMANA 20% 50mL BIOTEST A.G 2018-08-31 B235265 9961 2015-12-10 PR-2654 Merck Sharp & Dohme Corp. PNEUMOVAX 23 0,5mL Merck Sharp & Dohme Corp. 2017-04 L042608 4592 2015-12-10 PR-2655 ORPHAN PHARMA NORMOSANG 10mL Orphan Europe Sarl 2017-01 50156 120 2015-12-09 PR-2656 0,5mL Merck Sharp & Dohme Corp. 2018-01-14 L030775 135660 2015-12-15 FR-2657 0,5mL Merck Sharp & Dohme Corp. 2017-12-13 L030198 89000 2015-12-15 FR-2658 0,5mL Merck Sharp & Dohme Corp. 2018-01-14 L033045 25340 2015-12-15 FR-2659 2,5mL Bilthoven Biologicals 2018-02-25 IPV858A 42000 2015-12-15 FR-2661 2,5mL Bilthoven Biologicals 2018-02-25 IPV858B 60200 2015-12-15 FR-2662
2,5mL Bilthoven Biologicals 2018-02-25 IPV585C 57800 2015-12-15 FR-2663 FIAC FARMACEUTICA S.A.S UMAN ALBUMIN 200g/L 50mL Kedrion S.p.A. 2018-04 152918 11836 2015-12-10 PR-2664 VACUNA ANTITETANICA 0,5mL INSTITUTO FINLAY 2016-12 4101T 25613 2015-12-23 PR-2667 NISSI S.A.S OCTANINE F 500 UI 5mL 2018-05 A526A2208 290 2015-12-10 PR-2680 MENVEO 0,5mL Novartis Vaccines and Diagnostic S.r.l 2017-05 M15002 5000 2015-12-18 FR-2681 SYNFLORIX 0,5mL GlaxoSmithKline Biologicals S.A. 2017-02 ASPNA543AA 74400 2015-12-24 FR-2682 SYNFLORIX 0,5mL GlaxoSmithKline Biologicals S.A. 2017-02 ASPNA561AA 148000 2015-12-24 FR-2683 SYNFLORIX 0,5mL GlaxoSmithKline Biologicals S.A. 2017-03 ASPNA600AA 377600 2015-12-24 FR-2684 BIOSPIFAR S.A OCTAPLEX 500 UI 20mL OCTAPHARMA S.A.S. 2017-08 B536B2611 1000 2015-12-10 PR-2686 BIOPAS LABORATORIOS WILFACTIN 1000 UI 10mL LFB BIOMEDICAMENTS 2016-08 15L10790 348 2015-12-15 PR-2687 GRIFOLS COLOMBIA LTDA FANHDI 500 UI 10mL INSTITUTO GRIFOLS S.A. 2018-05 IBVB502171 2351 2015-12-15 PR-2688 BIOPAS LABORATORIOS WILFACTIN 1000 UI 10mL LFB BIOMEDICAMENTS 2018-02 15L10786 557 2015-12-15 PR-2689 KIOVIG 1g 10mL BAXTER S.A 2017-05 LE12Q202AG 300 2015-12-15 PR-2690
GAMMARAAS 100mL 2018-05-29 201505G009-1 1000 2015-12-15 PR-2691-R1 NISSI S.A.S WILATE 1000UI 10mL 2018-04 A522C1812 300 2015-12-24 PR-2692 TETADIF (VACUNA Td) 5mL BB-NCIPD 2018-03 D2273 18800 2015-12-22 FR-2693-R1 TYPHIM VI 10mL SANOFI PASTEUR S.A 2017-10-31 L1589-2 1200 2015-12-21 FR-2694 1mL Merck Sharp & Dohme Corp. 2018-01-13 L033046 7400 2015-12-21 FR-2696 0,5mL Merck Sharp & Dohme Corp. 2017-12-13 L030198 4400 2015-12-21 FR-2697-R1 IMMUNATE 1000 UI 10mL BAXTER A.G. 2017-06 VNC3Q058AD 1288 2015-12-15 PR-2698 IMMUNINE 600 UI 5mL BAXTER A.G. 2017-08 VNC1Q025AG 1404 2015-12-15 PR-2699 PENTAGLOBIN x 10 ml 10mL BIOTEST A.G 2017-05-31 B136135 50 2015-12-15 PR-2700-R3 SILCOV SAS VACUNA VIVA ATENUADA CONTRA EL SARAMPION, RUBEOLA Y PAPERAS (MMR) 0,5mL Serum Institute of India 2017-03 013N4102 20000 2015-12-03 PR-2701 FEIBA 500 U 20mL BAXTER A.G. 2017-07 VNF2Q056AA 1080 2015-12-15 PR-2705 FEIBA 1000 U 20mL BAXTER A.G. 2017-06 VNF2Q058AK 180 2015-12-15 PR-2706 GlaxoSmithKline Colombia S.A. HAVRIX 720 0,5mL GlaxoSmithKline Biologicals S.A. 2017-05 AHAVB831AA 10660 2015-12-21 PR-2708-R2 PENTAGLOBIN x 10 ml 10mL BIOTEST A.G 2017-05-31 B146065 71 2015-12-15 PR-2709 TISSEL LYO x 4mL 4mL BAXTER A.G. 2017-08 VNT5Q024AP 65 2015-12-15 PR-2710 TISSEL LYO x 2mL 2mL BAXTER A.G. 2017-08 VNT5Q025AD 65 2015-12-15 PR-2711 PFIZER S.A.S PREVENAR 13 VALENTE 0,5mL Pfizer Ireland Pharmaceuticals 2018-04 M79244 2232 2015-12-23 PR-2722 PFIZER S.A.S PREVENAR 13 VALENTE 0,5mL Pfizer Ireland Pharmaceuticals 2018-08 M79195 34551 2015-12-23 PR-2723 PFIZER S.A.S PREVENAR 13 VALENTE 0,5mL Pfizer Ireland Pharmaceuticals 2018-08 M79243 9794 2015-12-23 PR-2724 SANOFI PASTEUR S.A ADACEL 0,5mL SANOFI PASTEUR S.A 2017-08 C4797AC 10028 2015-12-24 PR-2772 SANOFI PASTEUR S.A ADACEL 0,5mL SANOFI PASTEUR S.A 2017-08 C4800AE 11859 2015-12-24 PR-2773