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5 3- {a-[(^9)-2-hydroxy-3'(2-morpholirocarbonylamino) ethylaminolprnpoxy I phenylpropionate monohydrnchloride

6

7

8

9

10

11

12 (!s/ml) a m El t) >1! 0 (mllmin) CR/F

13 Cmax (rrolml)

14 p= OOmg l5orngiln X li3oomg O,127nl

15

16

17 U rt )vrf'v ff5omg

18

19 (ne/ml)cmax 4?mg 56mg 6.461= I %

20

21 Tastellas BOnOtrgO%abrerssomg

22

23 Cmax 6c/mL) Cmax Tmax (nglml) (h)

24

25

26 Page I

27

28 Page 3 I lel600 rng l E3Fl

29 Page 4, ^jfltr E'7iB

30

31 Page 6

32 Page m8/et ms/ F fif

33

34 Page 9

35 Page 10

36

37

38 Page 13

39

40 Page 15 l?00ngef,f 1800ms/EFf

41

42 Page 17

43 600 mg 200 mg 400 mg 800 mg 400 mg 400 mg 400 mg 600 mg

44

45 x *+* xc!.t//r)>7 tu:1-tt 10. CaE

46 ,bu s l,tqfi

47

48

49

50 L0?;*i

51 Tnnx ftr) tuax (ng,hl) tr,'? ftr) IUC(ng'hr/nl,) CLi F ft,/ln)

52 85.7al,G/7) 5r,49i,(lB/35)

53

54 =-\r:fe00mc

55

56

57

58 AUC,t-r!eh (ng'hr,/ml) 8004) 1000q)

59

60

61

62 2007+t2E

63

64 I{2*E{FffiffrAtl 7 :-f t>

65

66 r4623 (48) r 023 (3 r) 28. 3yo (ri\/46fr))

67

68 @o:,'nv-z

69

70

71 mcanas. D.

72 l0mg mean-s. D- r,' s ml ) --.-lj.th TVtl mcants. D.

73 &?ijj (meanls. D. ) ft+fit lmea.ts, D. )

74

75

76

77 tona /l -,o.8rl

78

79

80

81

82

83 s8%s (r2t/2o8 FJ) l4%(t2187 Et)) 44o/"\ (41t9l FrJ) 40 mg+1 u

84 36y,e (27/76 Frl) (34ns9 Ftl) 61j) t2% (20 10 N) 36"/" s (62l17: F{)

85

86

87 Page 1 ZlfHRAlAe lntravenous use HffffiltE7t^tr v.( r>^7fr1h

88 Page 2

89 Page 3

90 Page 4 Itn E o-ro orl Cmax G9lnl-) X1 : n=9

91 Page 5

92 Page 6

93 Page 7

94 Velaglucerase alfa Shire Human Genetic Therapies, Inc,

95

d-00

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ø40, ø50, ø63, ø80, ø100 New RoHS ø % 1.31kg New CA2 1.54kg 3 New 3 1 D-M9 D-A9 D-P3DW D-P4DW CA2 Series CAT.S20-222A ø, ø, ø, ø, ø ew RoS ø-15% 1.31kg ew 2 1.54kg 3 ew 31 -M9-9 -P3W -P4W 2 Series T.S20-222 2 W2 V1 1 2 L L T 2 -- W -M9W 0.93 1.31 1.84 3.17 4.29 ew 2 ew 1 V 2 W ew ew 2 T V1 W2 2 1 2 Series EU-RoS ew 2

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