พรบ.ยา 2510
description
Transcript of พรบ.ยา 2510
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..2510
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... .. 2510
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- - - - ,corticosteriod, clofibrate, dipyrone, ARVs ,cisapride, misoprostol ,neuromuscular blocking agents, ...
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- - - , , ARVS , ABO, ..- : , Penicillin V potassium dry syrup 5 . . 2
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1.Dextromethorphan HBr 12 mg. 4 10 2.HCTZ 50 mg. 4 10 3.Ethinylestradiol 0.03-0.05 mg or Mestranol 0.03-0.05 mg. + Norgestrel 0.25-0.5 mg.or Levonorgestrel 0.125-0.25 mgor Norethisterone1.0-2.5 mgor Lynestrenol 1.0-2.5 mg
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()4. CPM 2 mg 4 20 5.Paracetamol 300 - 500 mg + CPM 1-2 mg 4 10 6. Aminophylline 100 mg 4 7. Theophylline anhydrous 60-150 mg+ Ephedrine HCL15-50 mg 4 8. Co-trimoxazole 400+80 mg 4 10 9. Phthalysulphathiazole 500 mg 4 20
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11. Mebendazole 100 mg or Mebendazole 500 mg per tablet 6 10 12.Dimenhydrinate 50 mg. 4 10 13. Sulphadoxine 500 mg + Pyrimethamine 25 mg 4 10 ()10. Penicillin V Potassium equivalent to Penicillin V 200,000 units 60 ml
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1. 2. 3. 4.
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4 1. 2. 3. 4.
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(. 15) 6 (1) (2) (3) (4) (5) (6)
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(1) (2) (3)
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(1) (2) (3) (4)
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(5) (6) () () () () (7)
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(8) (9) ()
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(.25) (1) (2) (3) (4) (5) (6) (7)
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(. 26)(1) (2) (3) (4) (5) (6) (7) (8) -
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26 (4) 26
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26
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( 27) (1) (2) (3) (4) (5) (6)
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(1) (2) (3) (4) (5) (6) (7)
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(8) (9) (10) (11) 76 (7) (8) , (1) (4) (11)
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( 46) ( 47) (1.) (2.) 76 (1)
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(2 ) (3.)(4.)
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1) 2) 3)
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1. (. ..)2. (. .. )3. (. ..)
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48 () 68 69 70 (4) (5) (6)
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( 57)1) 2 2) 3) 4) 5)
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6) ( 54 ) [ 25 (.. 2537) ] ()
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( 58)1) 2 2) 3)
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( 59) (1) 2 (2)
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(3) (4) (5) (56) ()
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(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
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.. 2510 ( 3) .. 2522 ( 5) .. 2530 4
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...( 79)
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2 1. 2.
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3 8.1.1 8.1.2 8.1.3
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( 83)(1) (2) (3) (4) (5)
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(New Drugs) (1) (New chemical entities) (New derivatives) (2) (New Indication) (3) / (New Combination) (4) (New delivery) (Bioavailability)
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8.2.1 (Original products)8.2.2 (Generic products)
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(Original products) 2 1. 2.
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Original products (Original products) (Condition Approval)
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Original products (1) (Protocol) 2 (2)
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(3) (Unconditional Approval)
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(Generic products) 3 1. (Bioequivalence)
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2. 8.1.1 3.
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3. 4. 5. 6.
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3 1. 2. 3.
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2 ) ) 83
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1. 2. 3. 4. (Disintegration time)5. (Dissolution time)6. 7.
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- - Accreditation overseas suppliers FDA certificate of free sale-
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(1) (2) (3) (4) (5)
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(1) (2) 86
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(1) (2)
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12. ( 88)(1) (2) (3)
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(4) (5) (6) (7) (8) 77
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(9) (.89)(10) (.90) ( 88 ) (1) (4) (5) (6) (7) (8)
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88 (1) ((2)
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