Adverse Event Report

Report

reporttype1Version of Safety Report ID6receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10161219serious1Date Last Updated25/07/2014receiptdateformat102companynumbPHEH2012US026123occurcountryUSseriousnessother1duplicate1Date Received08/05/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionOsteonecrosis of jawOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionInfectionOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionSinusitisOutcomeUnknown

4)

reactionmeddraversionpt17.1ReactionGynaecomastiaOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionOtitis mediaOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionTendernessOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionGingival bleedingOutcomeUnknown

8)

reactionmeddraversionpt17.1ReactionUpper-airway cough syndromeOutcomeUnknown

9)

reactionmeddraversionpt17.1ReactionLeft atrial dilatationOutcomeUnknown

10)

reactionmeddraversionpt17.1ReactionAortic valve incompetenceOutcomeUnknown

11)

reactionmeddraversionpt17.1ReactionPulmonary valve incompetenceOutcomeUnknown

12)

reactionmeddraversionpt17.1ReactionTooth infectionOutcomeUnknown

13)

reactionmeddraversionpt17.1ReactionGroin painOutcomeUnknown

14)

reactionmeddraversionpt17.1ReactionExostosisOutcomeUnknown

15)

reactionmeddraversionpt17.1ReactionArrhythmiaOutcomeUnknown

16)

reactionmeddraversionpt17.1ReactionIndurationOutcomeUnknown

17)

reactionmeddraversionpt17.1ReactionTooth lossOutcomeUnknown

18)

reactionmeddraversionpt17.1ReactionElectrocardiogram PR prolongationOutcomeUnknown

19)

reactionmeddraversionpt17.1ReactionSepsisOutcomeUnknown

20)

reactionmeddraversionpt17.1ReactionAbdominal painOutcomeUnknown

21)

reactionmeddraversionpt17.1ReactionChillsOutcomeUnknown

22)

reactionmeddraversionpt17.1ReactionHaemorrhoidsOutcomeUnknown

23)

reactionmeddraversionpt17.1ReactionIncisional herniaOutcomeUnknown

24)

reactionmeddraversionpt17.1ReactionPelvic cystOutcomeUnknown

25)

reactionmeddraversionpt17.1ReactionOsteosclerosisOutcomeUnknown

26)

reactionmeddraversionpt17.1ReactionSpinal osteoarthritisOutcomeUnknown

27)

reactionmeddraversionpt17.1ReactionPlasma cell myelomaOutcomeUnknown

28)

reactionmeddraversionpt17.1ReactionDepressionOutcomeUnknown

29)

reactionmeddraversionpt17.1ReactionHaematuriaOutcomeUnknown

30)

reactionmeddraversionpt17.1ReactionVision blurredOutcomeUnknown

31)

reactionmeddraversionpt17.1ReactionToothacheOutcomeUnknown

32)

reactionmeddraversionpt17.1ReactionLeft ventricular hypertrophyOutcomeUnknown

33)

reactionmeddraversionpt17.1ReactionOsteoarthritisOutcomeUnknown

34)

reactionmeddraversionpt17.1ReactionHyponatraemiaOutcomeUnknown

35)

reactionmeddraversionpt17.1ReactionFlank painOutcomeUnknown

36)

reactionmeddraversionpt17.1ReactionHyperthyroidismOutcomeUnknown

37)

reactionmeddraversionpt17.1ReactionHypertrophyOutcomeUnknown

38)

reactionmeddraversionpt17.1ReactionSeborrhoeic keratosisOutcomeUnknown

39)

reactionmeddraversionpt17.1ReactionAortic valve diseaseOutcomeUnknown

40)

reactionmeddraversionpt17.1ReactionTricuspid valve diseaseOutcomeUnknown

41)

reactionmeddraversionpt17.1ReactionNocturiaOutcomeUnknown

42)

reactionmeddraversionpt17.1ReactionHypothyroidismOutcomeUnknown

43)

reactionmeddraversionpt17.1ReactionRashOutcomeUnknown

44)

reactionmeddraversionpt17.1ReactionDiarrhoeaOutcomeUnknown

45)

reactionmeddraversionpt17.1ReactionChest painOutcomeUnknown

46)

reactionmeddraversionpt17.1ReactionAnxietyOutcomeUnknown

47)

reactionmeddraversionpt17.1ReactionHydronephrosisOutcomeUnknown

48)

reactionmeddraversionpt17.1ReactionAortic arteriosclerosisOutcomeUnknown

49)

reactionmeddraversionpt17.1ReactionDiscomfortOutcomeUnknown

50)

reactionmeddraversionpt17.1ReactionOsteitisOutcomeUnknown

51)

reactionmeddraversionpt17.1ReactionDehydrationOutcomeUnknown

52)

reactionmeddraversionpt17.1ReactionNeck massOutcomeUnknown

53)

reactionmeddraversionpt17.1ReactionLeukocytosisOutcomeUnknown

54)

reactionmeddraversionpt17.1ReactionBasal cell carcinomaOutcomeUnknown

55)

reactionmeddraversionpt17.1ReactionBlepharitisOutcomeUnknown

56)

reactionmeddraversionpt17.1ReactionDental cariesOutcomeUnknown

57)

reactionmeddraversionpt17.1ReactionErosive oesophagitisOutcomeUnknown

58)

reactionmeddraversionpt17.1ReactionProctalgiaOutcomeUnknown

59)

reactionmeddraversionpt17.1ReactionAnaemiaOutcomeUnknown

60)

reactionmeddraversionpt17.1ReactionDeafnessOutcomeUnknown

61)

reactionmeddraversionpt17.1ReactionMitral valve incompetenceOutcomeUnknown

62)

reactionmeddraversionpt17.1ReactionCardiac murmurOutcomeUnknown

63)

reactionmeddraversionpt17.1ReactionThyroid neoplasmOutcomeUnknown

64)

reactionmeddraversionpt17.1ReactionCarotid artery stenosisOutcomeUnknown

65)

reactionmeddraversionpt17.1ReactionMetastases to boneOutcomeUnknown

66)

reactionmeddraversionpt17.1ReactionPyuriaOutcomeUnknown

67)

reactionmeddraversionpt17.1ReactionDiverticulitisOutcomeUnknown

68)

reactionmeddraversionpt17.1ReactionVasodilatationOutcomeUnknown

69)

reactionmeddraversionpt17.1ReactionSecond primary malignancyOutcomeUnknown

70)

reactionmeddraversionpt17.1ReactionProteus test positiveOutcomeUnknown

71)

reactionmeddraversionpt17.1ReactionCardiac disorderOutcomeUnknown

72)

reactionmeddraversionpt17.1ReactionSoft tissue inflammationOutcomeUnknown

73)

reactionmeddraversionpt17.1ReactionRenal failureOutcomeUnknown

74)

reactionmeddraversionpt17.1ReactionPeriodontal diseaseOutcomeUnknown

75)

reactionmeddraversionpt17.1ReactionTachycardiaOutcomeUnknown

76)

reactionmeddraversionpt17.1ReactionAlopeciaOutcomeUnknown

77)

reactionmeddraversionpt17.1ReactionDizzinessOutcomeUnknown

78)

reactionmeddraversionpt17.1ReactionEmotional distressOutcomeUnknown

79)

reactionmeddraversionpt17.1ReactionDiverticulum intestinalOutcomeUnknown

80)

reactionmeddraversionpt17.1ReactionOsteomyelitisOutcomeUnknown

81)

reactionmeddraversionpt17.1ReactionIntervertebral disc space narrowingOutcomeUnknown

82)

reactionmeddraversionpt17.1ReactionPneumoniaOutcomeUnknown

83)

reactionmeddraversionpt17.1ReactionAtelectasisOutcomeUnknown

84)

reactionmeddraversionpt17.1ReactionConjunctival haemorrhageOutcomeUnknown

85)

reactionmeddraversionpt17.1ReactionUrosepsisOutcomeUnknown

86)

reactionmeddraversionpt17.1ReactionThyroid cystOutcomeUnknown

87)

reactionmeddraversionpt17.1ReactionSkin cancerOutcomeUnknown

88)

reactionmeddraversionpt17.1ReactionHypertensive heart diseaseOutcomeUnknown

89)

reactionmeddraversionpt17.1ReactionSwelling faceOutcomeUnknown

90)

reactionmeddraversionpt17.1ReactionFoot deformityOutcomeUnknown

91)

reactionmeddraversionpt17.1ReactionSquamous cell carcinoma of skinOutcomeUnknown

92)

reactionmeddraversionpt17.1ReactionMajor depressionOutcomeUnknown

93)

reactionmeddraversionpt17.1ReactionDeep vein thrombosisOutcomeUnknown

94)

reactionmeddraversionpt17.1ReactionHypokalaemiaOutcomeRecovered/resolved

95)

reactionmeddraversionpt17.1ReactionBack painOutcomeUnknown

96)

reactionmeddraversionpt17.1ReactionConstipationOutcomeUnknown

97)

reactionmeddraversionpt17.1ReactionHypocalcaemiaOutcomeUnknown

98)

reactionmeddraversionpt17.1ReactionLethargyOutcomeUnknown

99)

reactionmeddraversionpt17.1ReactionDeformityOutcomeUnknown

100)

reactionmeddraversionpt17.1ReactionPancreatic atrophyOutcomeUnknown

101)

reactionmeddraversionpt17.1ReactionExposed bone in jawOutcomeUnknown

102)

reactionmeddraversionpt17.1ReactionUpper respiratory tract infectionOutcomeUnknown

103)

reactionmeddraversionpt17.1ReactionGastritisOutcomeUnknown

104)

reactionmeddraversionpt17.1ReactionRhinorrhoeaOutcomeUnknown

105)

reactionmeddraversionpt17.1ReactionMalaiseOutcomeUnknown

106)

reactionmeddraversionpt17.1ReactionCarotid arteriosclerosisOutcomeUnknown

107)

reactionmeddraversionpt17.1ReactionCardiac valve diseaseOutcomeUnknown

108)

reactionmeddraversionpt17.1ReactionErectile dysfunctionOutcomeUnknown

109)

reactionmeddraversionpt17.1ReactionUreteric obstructionOutcomeUnknown

110)

reactionmeddraversionpt17.1ReactionVertebral foraminal stenosisOutcomeUnknown

111)

reactionmeddraversionpt17.1ReactionHepatic cystOutcomeUnknown

112)

reactionmeddraversionpt17.1ReactionGastroenteritisOutcomeUnknown

113)

reactionmeddraversionpt17.1ReactionRenal colicOutcomeUnknown

114)

reactionmeddraversionpt17.1ReactionMitral valve diseaseOutcomeUnknown

115)

reactionmeddraversionpt17.1ReactionNephropathyOutcomeUnknown

116)

reactionmeddraversionpt17.1ReactionCardiac failure congestiveOutcomeUnknown

117)

reactionmeddraversionpt17.1ReactionOedemaOutcomeUnknown

118)

reactionmeddraversionpt17.1ReactionDyspnoeaOutcomeUnknown

119)

reactionmeddraversionpt17.1ReactionDyspepsiaOutcomeUnknown

120)

reactionmeddraversionpt17.1ReactionPain in extremityOutcomeUnknown

121)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeUnknown

122)

reactionmeddraversionpt17.1ReactionPainOutcomeUnknown

123)

reactionmeddraversionpt17.1ReactionPhysical disabilityOutcomeUnknown

124)

reactionmeddraversionpt17.1ReactionNephrolithiasisOutcomeUnknown

125)

reactionmeddraversionpt17.1ReactionCardiomegalyOutcomeUnknown

126)

reactionmeddraversionpt17.1ReactionHypertensionOutcomeUnknown

127)

reactionmeddraversionpt17.1ReactionHypoxiaOutcomeUnknown

128)

reactionmeddraversionpt17.1ReactionRenal cystOutcomeUnknown

129)

reactionmeddraversionpt17.1ReactionInsulin resistanceOutcomeUnknown

130)

reactionmeddraversionpt17.1ReactionCoughOutcomeUnknown

131)

reactionmeddraversionpt17.1ReactionHyperglycaemiaOutcomeUnknown

132)

reactionmeddraversionpt17.1ReactionArthritisOutcomeUnknown

133)

reactionmeddraversionpt17.1ReactionOedema peripheralOutcomeUnknown

134)

reactionmeddraversionpt17.1ReactionKyphosisOutcomeUnknown

135)

reactionmeddraversionpt17.1ReactionTricuspid valve incompetenceOutcomeUnknown

136)

reactionmeddraversionpt17.1ReactionObesityOutcomeUnknown

137)

reactionmeddraversionpt17.1ReactionMusculoskeletal stiffnessOutcomeUnknown

138)

reactionmeddraversionpt17.1ReactionBladder cancerOutcomeUnknown

139)

reactionmeddraversionpt17.1ReactionTesticular atrophyOutcomeUnknown

140)

reactionmeddraversionpt17.1ReactionSinus tachycardiaOutcomeUnknown

141)

reactionmeddraversionpt17.1ReactionHyperkeratosisOutcomeUnknown

142)

reactionmeddraversionpt17.1ReactionAbdominal massOutcomeUnknown

143)

reactionmeddraversionpt17.1ReactionPapuleOutcomeUnknown

144)

reactionmeddraversionpt17.1ReactionSkin lesionOutcomeUnknown

145)

reactionmeddraversionpt17.1ReactionSebaceous hyperplasiaOutcomeUnknown

146)

reactionmeddraversionpt17.1ReactionErythemaOutcomeUnknown

147)

reactionmeddraversionpt17.1ReactionProstate cancer metastaticOutcomeUnknown

148)

reactionmeddraversionpt17.1ReactionGoitreOutcomeUnknown

149)

reactionmeddraversionpt17.1ReactionStress urinary incontinenceOutcomeUnknown

150)

reactionmeddraversionpt17.1ReactionChest discomfortOutcomeUnknown

151)

reactionmeddraversionpt17.1ReactionEndocarditisOutcomeUnknown

152)

reactionmeddraversionpt17.1ReactionDry eyeOutcomeUnknown

153)

reactionmeddraversionpt17.1ReactionAbdominal tendernessOutcomeUnknown

154)

reactionmeddraversionpt17.1ReactionFatigueOutcomeUnknown

155)

reactionmeddraversionpt17.1ReactionOropharyngeal painOutcomeUnknown

156)

reactionmeddraversionpt17.1ReactionLibido decreasedOutcomeUnknown

157)

reactionmeddraversionpt17.1ReactionNauseaOutcomeUnknown

158)

reactionmeddraversionpt17.1ReactionHepatic steatosisOutcomeUnknown

159)

reactionmeddraversionpt17.1ReactionPeripheral vascular disorderOutcomeUnknown

160)

reactionmeddraversionpt17.1ReactionPain in jawOutcomeUnknown

161)

reactionmeddraversionpt17.1ReactionHyperlipidaemiaOutcomeUnknown

162)

reactionmeddraversionpt17.1ReactionLarge intestine polypOutcomeUnknown

163)

reactionmeddraversionpt17.1ReactionBronchitisOutcomeUnknown

164)

reactionmeddraversionpt17.1ReactionPharyngitisOutcomeUnknown

165)

reactionmeddraversionpt17.1ReactionDiverticulumOutcomeUnknown

166)

reactionmeddraversionpt17.1ReactionUrinary tract infectionOutcomeUnknown

167)

reactionmeddraversionpt17.1ReactionCataractOutcomeUnknown

168)

reactionmeddraversionpt17.1ReactionGingival swellingOutcomeUnknown

169)

reactionmeddraversionpt17.1ReactionMyalgiaOutcomeUnknown

170)

reactionmeddraversionpt17.1ReactionGlucose tolerance impairedOutcomeUnknown

171)

reactionmeddraversionpt17.1ReactionAtrioventricular block first degreeOutcomeUnknown

172)

reactionmeddraversionpt17.1ReactionAngina pectorisOutcomeUnknown

173)

reactionmeddraversionpt17.1ReactionEmbolism venousOutcomeUnknown

174)

reactionmeddraversionpt17.1ReactionEssential hypertensionOutcomeUnknown

175)

reactionmeddraversionpt17.1ReactionAbdominal herniaOutcomeUnknown

176)

reactionmeddraversionpt17.1ReactionPlatelet count decreasedOutcomeUnknown

177)

reactionmeddraversionpt17.1ReactionHypermetropiaOutcomeUnknown

178)

reactionmeddraversionpt17.1ReactionBone painOutcomeUnknown

179)

reactionmeddraversionpt17.1ReactionAstheniaOutcomeUnknown

180)

reactionmeddraversionpt17.1ReactionMusculoskeletal painOutcomeUnknown

181)

reactionmeddraversionpt17.1ReactionDysphagiaOutcomeUnknown

182)

reactionmeddraversionpt17.1ReactionArthralgiaOutcomeUnknown

183)

reactionmeddraversionpt17.1ReactionInjuryOutcomeUnknown

184)

reactionmeddraversionpt17.1ReactionCalculus uretericOutcomeUnknown

185)

reactionmeddraversionpt17.1ReactionMetastases to spineOutcomeUnknown

186)

reactionmeddraversionpt17.1ReactionHypercalcaemiaOutcomeUnknown

187)

reactionmeddraversionpt17.1ReactionBone lesionOutcomeUnknown

188)

reactionmeddraversionpt17.1ReactionMassOutcomeUnknown

189)

reactionmeddraversionpt17.1ReactionPyelonephritisOutcomeUnknown

190)

reactionmeddraversionpt17.1ReactionThrombophlebitisOutcomeUnknown

191)

reactionmeddraversionpt17.1ReactionEczema nummularOutcomeUnknown

192)

reactionmeddraversionpt17.1ReactionUreteric dilatationOutcomeUnknown

193)

reactionmeddraversionpt17.1ReactionCellulitisOutcomeUnknown

194)

reactionmeddraversionpt17.1ReactionDyslipidaemiaOutcomeUnknown

195)

reactionmeddraversionpt17.1ReactionIntervertebral disc degenerationOutcomeUnknown

196)

reactionmeddraversionpt17.1ReactionMuscle spasmsOutcomeUnknown

197)

reactionmeddraversionpt17.1ReactionInfluenza like illnessOutcomeUnknown

198)

reactionmeddraversionpt17.1ReactionUrinary incontinenceOutcomeUnknown

199)

reactionmeddraversionpt17.1ReactionPeripheral swellingOutcomeUnknown

200)

reactionmeddraversionpt17.1ReactionGastrooesophageal reflux diseaseOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductPREDNISONE.actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

2)

drugcharacterization2medicinalproductNEUPOGENdrugrecurreadministration3

activesubstance

activesubstancenameFILGRASTIM

openFDA Info on Medication

Application NumberBLA103353Brand NameNEUPOGENGeneric NameFILGRASTIMManufacturersAmgen Incproduct_ndc55513-209, 55513-530, 55513-546, 55513-924Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsFILGRASTIMRXCUI727535, 727537, 727544, 727545, 1649944, 1649946, 1649963, 1649964spl_idc1cfd0ac-46b2-4b10-9fb8-a15e2286406dspl_set_id97cc73cc-b5b7-458a-a933-77b00523e193Package NDC 55513-530-01, 55513-530-10, 55513-546-01, 55513-546-10, 55513-924-01, 55513-924- ... NUIM0024696, M0024695, N0000009451, N0000175666Chemical Structure Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimul ... Physiologic/Pharmacodynamic EffectIncreased Myeloid Cell Production [PE]Established Pharmacologic ClassLeukocyte Growth Factor [EPC]UNIIPVI5M0M1GW

3)

drugcharacterization2medicinalproductZOLOFTdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductCARBOPLATIN.drugrecurreadministration3

activesubstance

activesubstancenameCARBOPLATIN

openFDA Info on Medication

Application Number ANDA077269, ANDA207324, ANDA208487, ANDA206775, ANDA076517, ANDA205487, ANDA0770 ... Brand NameCARBOPLATIN, PARAPLATINGeneric NameCARBOPLATINManufacturers Teva Parenteral Medicines, Inc., Gland Pharma Limited, Ingenus Pharmaceuticals, ... product_ndc 0703-4248, 68083-190, 68083-191, 68083-192, 68083-193, 0703-4239, 0703-4244, 070 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCARBOPLATINRXCUI597195, 686161spl_id 3437f49b-c018-4e10-9e20-8451243d209e, f171db85-7a96-42ae-a443-f31586f94803, 5f0f ... spl_set_id b5603e69-0ff0-4db0-b788-78b83ecb00d6, 9eb057eb-29ce-40d2-9ac8-ed107f25f5ab, f330 ... Package NDC 0703-4248-91, 68083-190-01, 68083-191-01, 68083-192-01, 68083-193-01, 0703-4244- ... NUIN0000175413, N0000175073Established Pharmacologic ClassPlatinum-based Drug [EPC]UNIIBG3F62OND5

5)

drugcharacterization2medicinalproductZYTIGAactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameABIRATERONE ACETATE

openFDA Info on Medication

Application NumberNDA202379Brand NameZYTIGAGeneric NameABIRATERONE ACETATEManufacturersJanssen Biotech, Inc.product_ndc57894-150, 57894-195Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsABIRATERONE ACETATERXCUI1100075, 1100079, 1918042, 1918044spl_id9c65c57b-4e84-4332-b446-5f792aa13deaspl_set_id4e338e89-3cf2-48eb-b6e2-a06c608c6513Package NDC57894-150-12, 57894-150-25, 57894-195-06, 57894-195-15UNIIEM5OCB9YJ6

6)

drugcharacterization2medicinalproductTAXOTEREdrugrecurreadministration3

activesubstance

activesubstancenameDOCETAXEL

openFDA Info on Medication

Application NumberNDA020449Brand NameTAXOTEREGeneric NameDOCETAXELManufacturersSanofi-Aventis U.S. LLCproduct_ndc0075-8004, 0075-8003Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsDOCETAXELRXCUI1860480, 1860482, 1860485, 1860486spl_idacb5d5b3-5112-4af8-ac03-2a42f619e0e2spl_set_id45e6dce4-92e2-4ad1-bf11-bbcefb753636Package NDC0075-8003-01, 0075-8004-04UNII15H5577CQD

7)

drugcharacterization1medicinalproductZOMETAdrugauthorizationnumb021223drugdosagetextUNK UKN, UNKdrugdosageformSOLUTION FOR INJECTIONdrugadministrationroute041drugindicationMETASTASES TO BONEdrugenddateformat102drugenddate27/09/2011actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameZOLEDRONIC ACID

8)

drugcharacterization2medicinalproductVICODINdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

9)

drugcharacterization2medicinalproductTRELSTAR LAactiondrug5drugrecurreadministration3

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHEH2012US026123

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use