N O T I C E S O F C O M P L I A N C E BIOLOGIC PRODUCTS FOR HUMAN USE January - December 1991 ----------------------------------------------------------------- Brand Name: ABBOKINASE Source: ABBOTT Active Ingredient: UROKINASE Comments: NEW INDICATION Date: 91/12/30 ----------------------------------------------------------------- Brand Name: ABBOKINASE Source: ABBOTT Active Ingredient: UROKINASE Comments: CHANGE IN MANUFACTURING SITE Date: 91/10/10 ----------------------------------------------------------------- Brand Name: ABBOKINASE Source: ABBOTT Active Ingredient: UROKINASE Comments: PWS (5,000 UNITS/MI) IV Date: 91/06/28 ----------------------------------------------------------------- Brand Name: ACTIVASE RT-PA Source: GENENTECH Active Ingredient: ALTEPLASE Comments: NEW DOSAGE REGIMEN Date: 91/03/18 ----------------------------------------------------------------- Brand Name: ACTIVASE RT-PA Source: GENENTECH Active Ingredient: ALTEPLASE Comments: NEW EXPIRATION DATE Date: 91/03/28 ----------------------------------------------------------------- Brand Name: ACTIVASE RT-PA Source: GENENTECH Active Ingredient: ALTEPLASE Comments: CHANGE IN PACKAGING Date: 91/05/01 ----------------------------------------------------------------- Brand Name: ALPHANINE Source: ALPHA THERAPEUTIC Active Ingredient: COAGULATION FACTOR IX (HUMAN) Comments: INJ LY (500 IU TO 1500 IU/VIAL) IV Date: 91/10/02 ----------------------------------------------------------------- Brand Name: CHOLECYSTOKININ Source: FERRING Active Ingredient: CHOLECYSTOKININ Comments: NEW EXPIRATION DATE Date: 91/08/02 ----------------------------------------------------------------- Brand Name: D2 T5 Source: IAF BIOVAC Active Ingredient: DIPHTHERIA AND TETANUS TOXOID ADSORBED Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/03/22 ----------------------------------------------------------------- Brand Name: DIGIBIND Source: BURROUGHS WELLCOME Active Ingredient: DIGOXIN IMMUNE Fab (OVINE) Comments: INJ LY (40 MG/VIAL) IV Date: 91/09/26 ----------------------------------------------------------------- Brand Name: EMINASE Source: SMITHKLINE BEECHAM Active Ingredient: ANISTREPLASE Comments: 30 UNIT VIAL Date: 91/03/18 ----------------------------------------------------------------- Brand Name: ENGERIX-B Source: SMITHKLINE BEECHAM Active Ingredient: RECOMBINANT HEPATITIS b VACCINE Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/03/20 ----------------------------------------------------------------- Brand Name: EPREX STERILE SOLUTION Source: ORTHO Active Ingredient: RECOMBINANT HUMAN ERYTHROPOIETIN Comments: CHANGE IN PACKAGING Date: 91/03/01 ----------------------------------------------------------------- Brand Name: HIB TITER Source: LEDERLE-CYANAMID Active Ingredient: HAEMOPHILUS B CONJUGATE VACCINE (DIPTHERIA CRM 197 PROTEIN CONJUGATE) Comments: INJ SOL (10, 25 MCG/0.5ML) IM Date: 91/08/30 ----------------------------------------------------------------- Brand Name: HYATE:C Source: PORTON SPEYWOOD Active Ingredient: PORCINE FACTOR VIII:C Comments: NEW EXPIRATION DATE Date: 91/09/09 ----------------------------------------------------------------- Brand Name: IMOGAM RABIES Source: CONNAUGHT Active Ingredient: RABIES IMMUNE GLOBULIN (HUMAN) Comments: CHANGE IN MANUFACTURER Date: 91/04/10 ----------------------------------------------------------------- Brand Name: INACTIVATED HUMAN RABIES VACCINE MERIEUX Source: CONNAUGHT Active Ingredient: WISTAR RABIES STRAIN Comments: CHANGE IN MANUFACTURER Date: 91/05/01 ----------------------------------------------------------------- Brand Name: INITARD NORDISK Source: NOVO NORDISK Active Ingredient: INSULIN (PORK) Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: INSULATARD HUMAN NPH Source: NOVO NORDISK Active Ingredient: INSULIN, HUMAN SEMI-SYNTHETIC Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: INTRON-A Source: SCHERING Active Ingredient: INTERFERON ALFA-2B Comments: NEW INDICATION Date: 91/01/21 ----------------------------------------------------------------- Brand Name: KONYNE-HT Source: MILES CANADA Active Ingredient: FACTOR IX COMPLEX Comments: CHANGE IN MANUFACTURING Date: 91/05/13 ----------------------------------------------------------------- Brand Name: MEASLES VIRUS VACCINE Source: IAF BIOVAC Active Ingredient: MEASLES VIRUS VACCINE, LIVE, ATTENUATED, FREEZE DRIED Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/03/22 ----------------------------------------------------------------- Brand Name: MIXTARD 15/85 (HUMAN) Source: NOVO NORDISK Active Ingredient: INSULIN, HUMAN SEMI-SYNTHETIC Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: MIXTARD 30/70 (HUMAN) Source: NOVO NORDISK Active Ingredient: INSULIN, HUMAN SEMI-SYNTHETIC Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: MIXTARD 50/50 (HUMAN) Source: NOVO NORDISK Active Ingredient: INSULIN, HUMAN SEMI-SYNTHETIC Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: MIXTARD NORDISK Source: NOVO NORDISK Active Ingredient: INSULIN (PORK) Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: MULTITEST CMI Source: CONNAUGHT Active Ingredient: SKIN TEST ANTIGENS Comments: CHANGE IN MANUFACTURER Date: 91/03/28 ----------------------------------------------------------------- Brand Name: ORTHOCLONE OKT*3 Source: ORTHO Active Ingredient: MUROMONAB-CD3 Comments: NEW INDICATION Date: 91/08/23 ----------------------------------------------------------------- Brand Name: ORTHOCLONE OKT*3 STERILE SOLUTION Source: ORTHO Active Ingredient: MUROMONAB-CD3 Comments: NEW EXPIRATION DATE Date: 91/12/03 ----------------------------------------------------------------- Brand Name: PEDVAX HIB Source: MERCK FROSST Active Ingredient: HAEMOPHILUS b CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE) Comments: INJ LY (15, 250 MCG/VIAL) IM Date: 91/08/30 ----------------------------------------------------------------- Brand Name: PNEUMOVAX 23 Source: MERCK FROSST Active Ingredient: PNEUMOCOCCAL VACCINE, POLYVALENT Comments: CHANGE IN PACKAGING Date: 91/08/12 ----------------------------------------------------------------- Brand Name: POLIO VIRUS VACCINE Source: CONNAUGHT Active Ingredient: POLIO VIRUS VACCINE Comments: CHANGE IN FORMULATION Date: 91/06/28 ----------------------------------------------------------------- Brand Name: POLIO VIRUS VACCINE Source: CONNAUGHT Active Ingredient: POLIO VIRUS VACCINE Comments: REVISED PRODUCT MONOGRAPH, REVISED LABELLING Date: 91/06/05 ----------------------------------------------------------------- Brand Name: POLIOVIRUS VACCINE LIVE, ORAL (SABIN) TRIVALENT Source: IAF BIOVAC Active Ingredient: POLIOVIRUS VACCINE LIVE, ORAL (SABIN) TRIVALENT Comments: CHANGE IN MANUFACTURER'S NAME, CHANGE IN MANUFACTURING Date: 91/07/31 ----------------------------------------------------------------- Brand Name: PROTROPIN Source: GENENTECH Active Ingredient: SOMATREM Comments: CHANGE IN MANUFACTURING Date: 91/08/21 ----------------------------------------------------------------- Brand Name: PROTROPIN Source: GENENTECH Active Ingredient: SOMATREM Comments: CHANGE IN PACKAGING Date: 91/01/29 ----------------------------------------------------------------- Brand Name: PROTROPIN Source: GENENTECH Active Ingredient: SOMATREM Comments: CHANGE IN PACKAGING Date: 91/05/01 ----------------------------------------------------------------- Brand Name: RECOMBIVAX-HB Source: MERCK FROSST Active Ingredient: HEPATITIS B VACCINE, RECOMBINANT Comments: CHANGE IN FORMULATION, NEW PACKAGING Date: 91/06/28 ----------------------------------------------------------------- Brand Name: ROFERON-A Source: HOFFMAN-LA ROCHE Active Ingredient: INTERFERON ALFA-2A Comments: NEW DOSAGE FORM Date: 91/01/31 ----------------------------------------------------------------- Brand Name: ROFERON-A Source: HOFFMAN-LA ROCHE Active Ingredient: INTERFERON ALFA-2A Comments: CHANGE IN PACKAGING Date: 91/05/29 ----------------------------------------------------------------- Brand Name: ROFERON-A Source: HOFFMAN-LA ROCHE Active Ingredient: INTERFERON ALFA-2A Comments: NEW DOSAGE FORM Date: 91/05/01 ----------------------------------------------------------------- Brand Name: RUBELLA VIRUS VACCINE Source: IAF BIOVAC Active Ingredient: RUBELLA VIRUS VACCINE, LIVE, ATTENUATED, FREEZE DRIED Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/03/22 ----------------------------------------------------------------- Brand Name: SECRETIN Source: FERRING Active Ingredient: SECRETIN Comments: NEW EXPIRATION DATE Date: 91/08/02 ----------------------------------------------------------------- Brand Name: STREPTASE Source: HOECHST Active Ingredient: STREPTOKINASE Comments: REVISED PRODUCT MONOGRAPH Date: 91/11/06 ----------------------------------------------------------------- Brand Name: TETANUS TOXOID ADSORBED Source: IAF BIOVAC Active Ingredient: TETANUS TOXOID ADSORBED Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/03/28 ----------------------------------------------------------------- Brand Name: TRASYLOL Source: MILES Active Ingredient: APROTININ Comments: CHANGE IN FORMULATION, NEW PACKAGING Date: 91/07/18 ----------------------------------------------------------------- Brand Name: VELOSULIN HUMAN Source: NOVO NORDISK Active Ingredient: INSULIN, HUMAN SEMI-SYNTHETIC Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: VELOSULIN NORDISK Source: NOVO NORDISK Active Ingredient: INSULIN (PORK) Comments: ALTERNATE SOURCE OF ACTIVE INGREDIENT Date: 91/07/31 ----------------------------------------------------------------- Brand Name: WINRHO Source: RH PHARMACEUTICALS Active Ingredient: RHO (D) IMMUNE GLOBULIN Comments: CHANGE IN MANUFACTURER'S NAME Date: 91/05/01 -----------------------------------------------------------------