li_item_id
stringlengths 7
30
| drug_name
stringlengths 4
169
| li_drug_name
stringlengths 4
169
⌀ | li_form
stringlengths 8
210
⌀ | schedule_form
stringlengths 21
261
⌀ | brand_name
stringlengths 3
88
⌀ | program_code
stringclasses 17
values | pbs_code
stringlengths 3
6
| benefit_type_code
stringclasses 4
values | caution_indicator
stringclasses 2
values | note_indicator
stringclasses 2
values | manner_of_administration
stringclasses 25
values | maximum_prescribable_pack
float64 0.08
200
⌀ | maximum_quantity_units
float64 1
2.1k
⌀ | number_of_repeats
float64 0
140
⌀ | organisation_id
float64 7
2.49k
⌀ | manufacturer_code
stringclasses 226
values | pack_size
float64 1
1k
⌀ | pricing_quantity
float64 1
1k
⌀ | pack_not_to_be_broken_ind
stringclasses 2
values | claimed_price
float64 0.75
2.53M
⌀ | determined_price
float64 0.75
2.53M
⌀ | determined_qty
stringclasses 2
values | safety_net_resupply_rule_days
float64 4
50
⌀ | safety_net_resup_rule_cnt_ind
stringclasses 2
values | extemporaneous_indicator
stringclasses 2
values | extemporaneous_standard
stringclasses 14
values | doctors_bag_group_id
float64 1
62
⌀ | section100_only_indicator
stringclasses 2
values | doctors_bag_only_indicator
stringclasses 2
values | brand_substitution_group_id
float64 14.6k
29.7k
⌀ | brand_substitution_group_code
stringclasses 2
values | supply_only_indicator
stringclasses 2
values | supply_only_date
stringclasses 9
values | non_effective_date
stringclasses 3
values | weighted_avg_disclosed_price
float64 | originator_brand_indicator
stringclasses 2
values | paper_med_chart_eligible_ind
stringclasses 2
values | elect_med_chart_eligible_ind
stringclasses 2
values | hsptl_med_chart_eligible_ind
stringclasses 2
values | paper_med_chart_duration
float64 4
4
⌀ | elect_med_chart_duration
float64 6
6
⌀ | hsptl_chart_acute_duration
float64 12
12
⌀ | hsptl_chart_sub_acute_duration
float64 12
12
⌀ | hsptl_chart_chronic_duration
float64 12
12
⌀ | pack_content
float64 1
20k
⌀ | vial_content
float64 1
15k
⌀ | infusible_indicator
stringclasses 2
values | unit_of_measure
stringclasses 6
values | continued_dispensing_flag
stringclasses 2
values | continued_dispensing_emergency
stringclasses 1
value | maximum_amount
float64 2
30k
⌀ | formulary
stringclasses 3
values | water_added_ind
stringclasses 2
values | section_19a_expiry_date
stringclasses 16
values | container_fee_type
stringclasses 2
values | policy_applied_imdq60_base_flag
stringclasses 2
values | policy_applied_imdq60_flag
stringclasses 2
values | policy_applied_bio_sim_up_flag
stringclasses 1
value | policy_applied_indig_phar_flag
stringclasses 2
values | therapeutic_exemption_indicator
stringclasses 2
values | premium_exemption_group_id
float64 1.34k
1.34k
⌀ | doctors_bag_group_title
stringclasses 1
value | therapeutic_group_id
float64 1.34k
1.34k
⌀ | therapeutic_group_title
stringclasses 1
value | advanced_notice_date
stringclasses 3
values | supply_only_end_date
stringclasses 8
values | first_listed_date
stringdate 1991-08-01 00:00:00
2025-05-01 00:00:00
⌀ | legal_unar_ind
stringclasses 2
values | legal_car_ind
stringclasses 2
values | schedule_code
int64 3.67k
3.67k
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
10001J_14023_31078_31081_31083
|
Rifaximin
|
Rifaximin
|
Tablet 550 mg
|
rifaximin 550 mg tablet, 56
|
Xifaxan
|
GE
|
10001J
|
A
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 122
|
NE
| 56
| 56
|
N
| 394.14
| 394.14
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10003L_13467_29812_29815_29817
|
Dabrafenib
|
Dabrafenib
|
Capsule 75 mg (as mesilate)
|
dabrafenib 75 mg capsule, 120
|
Tafinlar
|
GE
|
10003L
|
S
|
N
|
Y
|
ORAL
| 1
| 120
| 5
| 25
|
NV
| 120
| 120
|
N
| 6,995.23
| 6,995.23
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10004M_7501_1327_5783_52398
|
Sunitinib
|
Sunitinib
|
Capsule 12.5 mg
|
sunitinib 12.5 mg capsule, 28
|
Sunitinib Sandoz
|
GE
|
10004M
|
A
|
N
|
Y
|
ORAL
| 1
| 28
| 2
| 90
|
SZ
| 28
| 28
|
N
| 513.55
| 513.55
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,573
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-10-01
|
N
|
N
| 3,671
|
10004M_7501_1327_5783_7045
|
Sunitinib
|
Sunitinib
|
Capsule 12.5 mg
|
sunitinib 12.5 mg capsule, 28
|
Sutent
|
GE
|
10004M
|
A
|
N
|
Y
|
ORAL
| 1
| 28
| 2
| 69
|
PF
| 28
| 28
|
N
| 513.55
| 513.55
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,573
|
a
|
N
| null | null | null |
Y
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10005N_14031_31172_31177_31179
|
Olmesartan + amlodipine + hydrochlorothiazide
|
Olmesartan with amlodipine and hydrochlorothiazide
|
Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
|
olmesartan medoxomil 20 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg tablet, 30
|
Sevikar HCT 20/5/12.5
|
GE
|
10005N
|
R
|
N
|
N
|
ORAL
| 1
| 30
| 5
| 142
|
AF
| 30
| 30
|
N
| 8.36
| 5.57
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 23,701
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10005N_14031_31172_31177_48899
|
Olmesartan + amlodipine + hydrochlorothiazide
|
Olmesartan with amlodipine and hydrochlorothiazide
|
Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
|
olmesartan medoxomil 20 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg tablet, 30
|
Olmekar HCT 20/5/12.5
|
GE
|
10005N
|
R
|
N
|
N
|
ORAL
| 1
| 30
| 5
| 1,081
|
RF
| 30
| 30
|
N
| 5.57
| 5.57
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 23,701
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2020-10-01
|
N
|
N
| 3,671
|
10005N_14031_31172_31177_49303
|
Olmesartan + amlodipine + hydrochlorothiazide
|
Olmesartan with amlodipine and hydrochlorothiazide
|
Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
|
olmesartan medoxomil 20 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg tablet, 30
|
APO-Olmesartan/Amlodipine/HCTZ 20/5/12.5
|
GE
|
10005N
|
R
|
N
|
N
|
ORAL
| 1
| 30
| 5
| 72
|
TX
| 30
| 30
|
N
| 5.57
| 5.57
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 23,701
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2020-04-01
|
N
|
N
| 3,671
|
10005N_14031_31172_31177_54877
|
Olmesartan + amlodipine + hydrochlorothiazide
|
Olmesartan with amlodipine and hydrochlorothiazide
|
Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
|
olmesartan medoxomil 20 mg + amlodipine 5 mg + hydrochlorothiazide 12.5 mg tablet, 30
|
Olamlo HCT 20/5/12.5
|
GE
|
10005N
|
R
|
N
|
N
|
ORAL
| 1
| 30
| 5
| 142
|
AL
| 30
| 30
|
N
| 5.57
| 5.57
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 23,701
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2023-03-01
|
N
|
N
| 3,671
|
10007Q_14069_31262_31272_31274
|
fluticasone propionate + formoterol
|
Fluticasone propionate with formoterol
|
Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses
|
fluticasone propionate 125 microgram/actuation + formoterol fumarate dihydrate 5 microgram/actuation inhalation, 120 actuations
|
flutiform 125/5
|
GE
|
10007Q
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 1
| 1
| 5
| 134
|
MF
| 1
| 1
|
Y
| 24.54
| 24.54
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null | null |
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10008R_14070_31262_31278_31280
|
fluticasone propionate + formoterol
|
Fluticasone propionate with formoterol
|
Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses
|
fluticasone propionate 250 microgram/actuation + formoterol fumarate dihydrate 10 microgram/actuation inhalation, 120 actuations
|
flutiform 250/10
|
GE
|
10008R
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 1
| 1
| 5
| 134
|
MF
| 1
| 1
|
Y
| 35.44
| 35.44
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null | null |
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10009T_7501_1327_5783_52398
|
Sunitinib
|
Sunitinib
|
Capsule 12.5 mg
|
sunitinib 12.5 mg capsule, 28
|
Sunitinib Sandoz
|
GE
|
10009T
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 90
|
SZ
| 28
| 28
|
N
| 513.55
| 513.55
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,574
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-10-01
|
N
|
N
| 3,671
|
10009T_7501_1327_5783_7045
|
Sunitinib
|
Sunitinib
|
Capsule 12.5 mg
|
sunitinib 12.5 mg capsule, 28
|
Sutent
|
GE
|
10009T
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 69
|
PF
| 28
| 28
|
N
| 513.55
| 513.55
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,574
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10010W_10254_1327_5785_52407
|
Sunitinib
|
Sunitinib
|
Capsule 50 mg
|
sunitinib 50 mg capsule, 28
|
Sunitinib Sandoz
|
GE
|
10010W
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 90
|
SZ
| 28
| 28
|
N
| 2,092.68
| 2,092.68
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,555
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-10-01
|
N
|
N
| 3,671
|
10010W_10254_1327_5785_54449
|
Sunitinib
|
Sunitinib
|
Capsule 50 mg
|
sunitinib 50 mg capsule, 28
|
ARX-Sunitinib
|
GE
|
10010W
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 1,908
|
XT
| 28
| 28
|
N
| 2,092.68
| 2,092.68
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,555
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2022-09-01
|
N
|
N
| 3,671
|
10010W_10254_1327_5785_7047
|
Sunitinib
|
Sunitinib
|
Capsule 50 mg
|
sunitinib 50 mg capsule, 28
|
Sutent
|
GE
|
10010W
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 69
|
PF
| 28
| 28
|
N
| 2,092.68
| 2,092.68
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 25,555
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10011X_12926_28323_28324_28328
|
Dapagliflozin
|
Dapagliflozin
|
Tablet 10 mg (as propanediol monohydrate)
|
dapagliflozin 10 mg tablet, 28
|
Forxiga
|
GE
|
10011X
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 76
|
AP
| 28
| 28
|
N
| 36.61
| 36.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F1
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10012Y_14042_31242_31245_31247
|
Ivabradine
|
Ivabradine
|
Tablet 5 mg (as hydrochloride)
|
ivabradine 5 mg tablet, 56
|
Coralan
|
GE
|
10012Y
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 75
|
SE
| 56
| 56
|
N
| 31.03
| 31.03
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 22,577
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2013-12-01
|
N
|
N
| 3,671
|
10012Y_14042_31242_31245_46055
|
Ivabradine
|
Ivabradine
|
Tablet 5 mg (as hydrochloride)
|
ivabradine 5 mg tablet, 56
|
APO-Ivabradine
|
GE
|
10012Y
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 72
|
TX
| 56
| 56
|
N
| 31.03
| 31.03
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 22,577
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2018-10-01
|
N
|
N
| 3,671
|
10012Y_14042_31242_31245_58372
|
Ivabradine
|
Ivabradine
|
Tablet 5 mg (as hydrochloride)
|
ivabradine 5 mg tablet, 56
|
IVABRADINE-WGR
|
GE
|
10012Y
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 2,410
|
WG
| 56
| 56
|
N
| 31.03
| 31.03
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 22,577
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2024-09-01
|
N
|
N
| 3,671
|
10014C_9584_1305_5723_51489
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10014C
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,897
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10014C_9584_1305_5723_51646
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10014C
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,897
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10014C_9584_1305_5723_59500
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10014C
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,897
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-01-01
|
N
|
N
| 3,671
|
10015D_14170_1161_31502_31504
|
Budesonide + formoterol
|
Budesonide with formoterol
|
Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses
|
budesonide 100 microgram/actuation + formoterol fumarate dihydrate 3 microgram/actuation inhalation, 120 actuations
|
Symbicort Rapihaler 100/3
|
GE
|
10015D
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 2
| 2
| 5
| 76
|
AP
| 1
| 1
|
N
| 15.71
| 13.4
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| 27,578
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
10015D_14170_1161_31502_56565
|
Budesonide + formoterol
|
Budesonide with formoterol
|
Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses
|
budesonide 100 microgram/actuation + formoterol fumarate dihydrate 3 microgram/actuation inhalation, 120 actuations
|
Rilast RAPIHALER 100/3
|
GE
|
10015D
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 2
| 2
| 5
| 1,908
|
XT
| 1
| 1
|
N
| 13.4
| 13.4
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| 27,578
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2023-08-01
|
N
|
N
| 3,671
|
10017F_22428_31353_31356_31358
|
dressing foam with silicone
|
Dressing-foam with silicone
|
Dressings 10.3 cm x 10.3 cm, 10
|
dressing foam with silicone 10.3 cm x 10.3 cm dressing, 10
|
Allevyn Life 66801067
|
R1
|
10017F
|
U
|
N
|
Y
|
FOR_EXTERNAL_USE
| 1
| 1
| 0
| 100
|
SN
| 1
| 1
|
Y
| 56.87
| 56.87
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null | null |
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
10018G_14171_1161_31505_31507
|
Budesonide + formoterol
|
Budesonide with formoterol
|
Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
|
budesonide 200 microgram/actuation + formoterol fumarate dihydrate 6 microgram/actuation inhalation, 120 actuations
|
Symbicort Rapihaler 200/6
|
GE
|
10018G
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 2
| 2
| 5
| 76
|
AP
| 1
| 1
|
N
| 24.37
| 22.06
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| 27,585
|
a
|
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
10018G_14171_1161_31505_56566
|
Budesonide + formoterol
|
Budesonide with formoterol
|
Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
|
budesonide 200 microgram/actuation + formoterol fumarate dihydrate 6 microgram/actuation inhalation, 120 actuations
|
Rilast RAPIHALER 200/6
|
GE
|
10018G
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 2
| 2
| 5
| 1,908
|
XT
| 1
| 1
|
N
| 22.06
| 22.06
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| 27,585
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2023-08-01
|
N
|
N
| 3,671
|
10019H_8909_1305_5722_51488
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10019H
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,894
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10019H_8909_1305_5722_51645
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10019H
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,894
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10019H_8909_1305_5722_59685
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10019H
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,894
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-03-01
|
N
|
N
| 3,671
|
10020J_8909_1305_5722_51488
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10020J
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,881
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10020J_8909_1305_5722_51645
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10020J
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,881
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10020J_8909_1305_5722_59685
|
Erlotinib
|
Erlotinib
|
Tablet 100 mg (as hydrochloride)
|
erlotinib 100 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10020J
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 379.6
| 379.6
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,881
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-03-01
|
N
|
N
| 3,671
|
10021K_22429_31353_31371_31373
|
dressing foam with silicone
|
Dressing-foam with silicone
|
Dressings 21 cm x 21 cm, 10
|
dressing foam with silicone 21 cm x 21 cm dressing, 10
|
Allevyn Life 66801070
|
R1
|
10021K
|
U
|
N
|
Y
|
FOR_EXTERNAL_USE
| 1
| 1
| 0
| 100
|
SN
| 1
| 1
|
Y
| 252.55
| 252.55
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null | null |
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
10022L_10263_1305_5724_51487
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10022L
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,909
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10022L_10263_1305_5724_51644
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10022L
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,909
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10022L_10263_1305_5724_65904
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10022L
|
A
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,909
|
a
|
N
| null | null | null |
N
|
N
|
Y
|
Y
| null | 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-04-01
|
N
|
N
| 3,671
|
10023M_22430_31353_31366_31368
|
dressing foam with silicone
|
Dressing-foam with silicone
|
Dressings 15.4 cm x 15.4 cm, 10
|
dressing foam with silicone 15.4 cm x 15.4 cm dressing, 10
|
Allevyn Life 66801069
|
R1
|
10023M
|
U
|
N
|
Y
|
FOR_EXTERNAL_USE
| 1
| 1
| 0
| 100
|
SN
| 1
| 1
|
Y
| 121.62
| 121.62
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null | null |
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
10025P_9584_1305_5723_51489
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10025P
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,914
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10025P_9584_1305_5723_51646
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10025P
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,914
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10025P_9584_1305_5723_59500
|
Erlotinib
|
Erlotinib
|
Tablet 150 mg (as hydrochloride)
|
erlotinib 150 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10025P
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 469.61
| 469.61
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,914
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-01-01
|
N
|
N
| 3,671
|
10028T_10263_1305_5724_51487
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
Erlotinib Sandoz
|
GE
|
10028T
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 90
|
SZ
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,895
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-04-01
|
N
|
N
| 3,671
|
10028T_10263_1305_5724_51644
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
Erlotinib APOTEX
|
GE
|
10028T
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 72
|
TX
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,895
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10028T_10263_1305_5724_65904
|
Erlotinib
|
Erlotinib
|
Tablet 25 mg (as hydrochloride)
|
erlotinib 25 mg tablet, 30
|
ERLOTINIB ARX
|
GE
|
10028T
|
S
|
N
|
N
|
ORAL
| 1
| 30
| 3
| 1,908
|
XT
| 30
| 30
|
N
| 104.59
| 104.59
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 24,895
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2025-04-01
|
N
|
N
| 3,671
|
10029W_22431_31353_31361_31363
|
dressing foam with silicone
|
Dressing-foam with silicone
|
Dressings 12.9 cm x 12.9 cm, 10
|
dressing foam with silicone 12.9 cm x 12.9 cm dressing, 10
|
Allevyn Life 66801068
|
R1
|
10029W
|
U
|
N
|
Y
|
FOR_EXTERNAL_USE
| 1
| 1
| 0
| 100
|
SN
| 1
| 1
|
Y
| 85.34
| 85.34
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null | null |
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-01-01
|
N
|
N
| 3,671
|
1002R_8397_129_1423_51618
|
Aciclovir
|
Aciclovir
|
Eye ointment 30 mg per g, 4.5 g
|
aciclovir 3% eye ointment, 4.5 g
|
XOROX
|
GE
|
1002R
|
R
|
N
|
N
|
APPLICATION_TO_THE_EYE
| 1
| 1
| 0
| 118
|
IX
| 1
| 1
|
Y
| 14.08
| 14.08
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 22,959
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-08-01
|
N
|
N
| 3,671
|
1002R_8397_129_1423_51674
|
Aciclovir
|
Aciclovir
|
Eye ointment 30 mg per g, 4.5 g
|
aciclovir 3% eye ointment, 4.5 g
|
ViruPOS
|
GE
|
1002R
|
R
|
N
|
N
|
APPLICATION_TO_THE_EYE
| 1
| 1
| 0
| 38
|
AE
| 1
| 1
|
Y
| 14.08
| 14.08
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 22,959
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null | null |
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2021-05-01
|
N
|
N
| 3,671
|
10032B_13948_30819_30835_30837
|
Alogliptin + metformin
|
Alogliptin with metformin
|
Tablet containing 12.5 mg alogliptin (as benzoate) with 850 mg metformin hydrochloride
|
alogliptin 12.5 mg + metformin hydrochloride 850 mg tablet, 56
|
Nesina Met 12.5/850
|
GE
|
10032B
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 104
|
TK
| 56
| 56
|
N
| 38.03
| 38.03
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-02-01
|
N
|
N
| 3,671
|
10033C_13947_30819_30832_30834
|
Alogliptin + metformin
|
Alogliptin with metformin
|
Tablet containing 12.5 mg alogliptin (as benzoate) with 500 mg metformin hydrochloride
|
alogliptin 12.5 mg + metformin hydrochloride 500 mg tablet, 56
|
Nesina Met 12.5/500
|
GE
|
10033C
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 104
|
TK
| 56
| 56
|
N
| 37.13
| 37.13
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-02-01
|
N
|
N
| 3,671
|
10034D_12927_185_29160_29162
|
Budesonide
|
Budesonide
|
Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2
|
budesonide 2 mg/application foam, 2 x 14 applications
|
Budenofalk
|
GE
|
10034D
|
U
|
N
|
Y
|
RECTAL
| 1
| 1
| 3
| 1,688
|
FD
| 1
| 1
|
N
| 127.07
| 127.07
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-02-01
|
N
|
N
| 3,671
|
10035E_13946_30819_30829_30831
|
Alogliptin + metformin
|
Alogliptin with metformin
|
Tablet containing 12.5 mg alogliptin (as benzoate) with 1 g metformin hydrochloride
|
alogliptin 12.5 mg + metformin hydrochloride 1 g tablet, 56
|
Nesina Met 12.5/1000
|
GE
|
10035E
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 104
|
TK
| 56
| 56
|
N
| 38.39
| 38.39
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-02-01
|
N
|
N
| 3,671
|
10036F_14213_31583_31586_31588
|
arachidonic acid and docosahexaenoic acid with carbohydrate
|
Arachidonic acid and docosahexaenoic acid with carbohydrate
|
Sachets of oral powder 4 g containing 200 mg arachidonic acid and 100 mg docosahexaenoic acid, 30 (keyomega)
|
arachidonic acid and docosahexaenoic acid with carbohydrate containing 200 mg arachidonic acid and 100 mg docosahexaenoic acid powder for oral liquid, 30 x 4 g sachets
|
keyomega
|
GE
|
10036F
|
R
|
N
|
N
|
ORAL
| 4
| 4
| 5
| 126
|
VF
| 1
| 1
|
N
| 72.68
| 72.68
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10038H_14316_32112_32116_32118
|
Linagliptin + metformin
|
Linagliptin with metformin
|
Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride
|
linagliptin 2.5 mg + metformin hydrochloride 500 mg tablet, 60
|
Trajentamet
|
GE
|
10038H
|
S
|
N
|
Y
|
ORAL
| 1
| 60
| 5
| 71
|
BY
| 60
| 60
|
N
| 40.23
| 40.23
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10039J_14230_31595_31598_31600
|
carbohydrates, fat, vitamins, minerals, trace elements and supplemented with arachidonic acid and docosahexaenoic acid
|
Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid
|
Sachets containing oral powder 43 g, 30 (basecal 200)
|
carbohydrates, fat, vitamins, minerals, trace elements and supplemented with arachidonic acid and docosahexaenoic acid providing 200 kilocalories powder for oral liquid, 30 x 43 g sachets
|
basecal 200
|
GE
|
10039J
|
R
|
N
|
N
|
ORAL
| 4
| 4
| 5
| 126
|
VF
| 1
| 1
|
N
| 93.96
| 93.96
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
1003T_11093_129_1424_36965
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 25
|
Aciclovir Sandoz
|
GE
|
1003T
|
S
|
N
|
Y
|
ORAL
| 2
| 50
| 0
| 90
|
HX
| 25
| 25
|
N
| 4.7
| 4.7
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 15,446
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2015-06-01
|
N
|
N
| 3,671
|
10041L_8372_25323_25329_25333
|
Pazopanib
|
Pazopanib
|
Tablet 400 mg (as hydrochloride)
|
pazopanib 400 mg tablet, 60
|
Votrient
|
GE
|
10041L
|
S
|
N
|
Y
|
ORAL
| 1
| 60
| 2
| 25
|
NV
| 60
| 30
|
N
| 4,085.88
| 2,042.94
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10042M_9052_25323_25324_25328
|
Pazopanib
|
Pazopanib
|
Tablet 200 mg (as hydrochloride)
|
pazopanib 200 mg tablet, 90
|
Votrient
|
GE
|
10042M
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 2
| 25
|
NV
| 90
| 30
|
N
| 3,064.41
| 1,021.47
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10043N_8372_25323_25329_25333
|
Pazopanib
|
Pazopanib
|
Tablet 400 mg (as hydrochloride)
|
pazopanib 400 mg tablet, 60
|
Votrient
|
GE
|
10043N
|
S
|
N
|
Y
|
ORAL
| 1
| 60
| 5
| 25
|
NV
| 60
| 30
|
N
| 4,085.88
| 2,042.94
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10044P_14315_32112_32128_32130
|
Linagliptin + metformin
|
Linagliptin with metformin
|
Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride
|
linagliptin 2.5 mg + metformin hydrochloride 1 g tablet, 60
|
Trajentamet
|
GE
|
10044P
|
S
|
N
|
Y
|
ORAL
| 1
| 60
| 5
| 71
|
BY
| 60
| 60
|
N
| 41.45
| 41.45
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10045Q_14317_32112_32122_32124
|
Linagliptin + metformin
|
Linagliptin with metformin
|
Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride
|
linagliptin 2.5 mg + metformin hydrochloride 850 mg tablet, 60
|
Trajentamet
|
GE
|
10045Q
|
S
|
N
|
Y
|
ORAL
| 1
| 60
| 5
| 71
|
BY
| 60
| 60
|
N
| 41.01
| 41.01
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10046R_14210_1164_31608_31610
|
Bimatoprost
|
Bimatoprost
|
Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30
|
bimatoprost 0.03% eye drops, 30 x 0.4 mL ampoules
|
Lumigan PF
|
GE
|
10046R
|
U
|
N
|
N
|
APPLICATION_TO_THE_EYE
| 1
| 1
| 5
| 68
|
VE
| 1
| 1
|
Y
| 15.41
| 15.41
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null | null |
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10047T_9052_25323_25324_25328
|
Pazopanib
|
Pazopanib
|
Tablet 200 mg (as hydrochloride)
|
pazopanib 200 mg tablet, 90
|
Votrient
|
GE
|
10047T
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 25
|
NV
| 90
| 30
|
N
| 3,064.41
| 1,021.47
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10048W_14312_32134_32150_32152
|
Saxagliptin + metformin
|
Saxagliptin with metformin
|
Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
|
saxagliptin 2.5 mg + metformin hydrochloride 1 g modified release tablet, 56
|
Kombiglyze XR 2.5/1000
|
GE
|
10048W
|
S
|
N
|
Y
|
ORAL
| 1
| 56
| 5
| 76
|
AP
| 56
| 56
|
N
| 38.41
| 38.41
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
1004W_10416_126_1419_5981
|
Acetazolamide
|
Acetazolamide
|
Tablet 250 mg
|
acetazolamide 250 mg tablet, 100
|
Diamox
|
GE
|
1004W
|
U
|
N
|
Y
|
ORAL
| 1
| 100
| 3
| 1,081
|
RW
| 100
| 100
|
N
| 9.78
| 9.78
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2005-04-01
|
N
|
N
| 3,671
|
10051B_14313_32134_32144_32146
|
Saxagliptin + metformin
|
Saxagliptin with metformin
|
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride
|
saxagliptin 5 mg + metformin hydrochloride 1 g modified release tablet, 28
|
Kombiglyze XR 5/1000
|
GE
|
10051B
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 76
|
AP
| 28
| 28
|
N
| 37.28
| 37.28
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10052C_8372_25323_25931_25933
|
Pazopanib
|
Pazopanib
|
Tablet 400 mg (as hydrochloride)
|
pazopanib 400 mg tablet, 30
|
Votrient
|
GE
|
10052C
|
S
|
N
|
Y
|
ORAL
| 1
| 30
| 5
| 25
|
NV
| 30
| 30
|
N
| 2,042.94
| 2,042.94
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10053D_14210_1164_31608_31610
|
Bimatoprost
|
Bimatoprost
|
Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30
|
bimatoprost 0.03% eye drops, 30 x 0.4 mL ampoules
|
Lumigan PF
|
GE
|
10053D
|
U
|
N
|
Y
|
APPLICATION_TO_THE_EYE
| 1
| 1
| 5
| 68
|
VE
| 1
| 1
|
Y
| 15.41
| 15.41
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null | null |
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10054E_9052_25323_25928_25930
|
Pazopanib
|
Pazopanib
|
Tablet 200 mg (as hydrochloride)
|
pazopanib 200 mg tablet, 30
|
Votrient
|
GE
|
10054E
|
S
|
N
|
Y
|
ORAL
| 1
| 30
| 5
| 25
|
NV
| 30
| 30
|
N
| 1,021.47
| 1,021.47
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10055F_14314_32134_32138_32140
|
Saxagliptin + metformin
|
Saxagliptin with metformin
|
Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride
|
saxagliptin 5 mg + metformin hydrochloride 500 mg modified release tablet, 28
|
Kombiglyze XR 5/500
|
GE
|
10055F
|
S
|
N
|
Y
|
ORAL
| 1
| 28
| 5
| 76
|
AP
| 28
| 28
|
N
| 36.54
| 36.54
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
Y
|
N
| null |
CDL
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-03-01
|
N
|
N
| 3,671
|
10056G_8853_1373_5889_7175
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 200 mg in 10 mL
|
tocilizumab 200 mg/10 mL injection, 10 mL vial
|
Actemra
|
HB
|
10056G
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 203.73
| 203.73
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10057H_11574_1167_5317_38268
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Inflectra
|
HS
|
10057H
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 69
|
PF
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,386
|
a
|
N
| null | null | null |
N
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2015-12-01
|
N
|
Y
| 3,671
|
10057H_11574_1167_5317_41027
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Renflexis
|
HS
|
10057H
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 1,829
|
OQ
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,386
|
a
|
N
| null | null | null |
N
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2017-08-01
|
N
|
Y
| 3,671
|
10057H_11574_1167_5317_6278
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Remicade
|
HS
|
10057H
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 63
|
JC
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,386
|
a
|
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10058J_8853_1373_5889_7175
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 200 mg in 10 mL
|
tocilizumab 200 mg/10 mL injection, 10 mL vial
|
Actemra
|
HB
|
10058J
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 203.73
| 203.73
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10059K_13916_30738_30742_30744
|
Glycopyrronium
|
Glycopyrronium
|
Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler)
|
glycopyrronium 50 microgram powder for inhalation, 30 capsules
|
seebri breezhaler
|
GE
|
10059K
|
R
|
N
|
Y
|
INHALATION_BY_MOUTH
| 1
| 30
| 5
| 25
|
NV
| 30
| 30
|
N
| 42.7
| 42.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10060L_8855_1373_5890_7176
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 400 mg in 20 mL
|
tocilizumab 400 mg/20 mL injection, 20 mL vial
|
Actemra
|
HS
|
10060L
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 405.39
| 405.39
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10061M_7360_1385_5923_7212
|
Denosumab
|
Denosumab
|
Injection 120 mg in 1.7 mL
|
denosumab 120 mg/1.7 mL injection, 1.7 mL vial
|
Xgeva
|
GE
|
10061M
|
S
|
N
|
Y
|
INJECTION
| 1
| 1
| 5
| 43
|
AN
| 1
| 1
|
N
| 401.85
| 401.85
|
N
| 20
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10062N_12690_1083_28137_37284
|
Temozolomide
|
Temozolomide
|
Capsule 180 mg
|
temozolomide 180 mg capsule, 5
|
APO-Temozolomide
|
GE
|
10062N
|
R
|
N
|
Y
|
ORAL
| 3
| 15
| 2
| 72
|
TX
| 5
| 5
|
N
| 99.7
| 99.7
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,168
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2015-07-01
|
N
|
N
| 3,671
|
10062N_12690_1083_28137_47751
|
Temozolomide
|
Temozolomide
|
Capsule 180 mg
|
temozolomide 180 mg capsule, 5
|
Temozolomide Juno
|
GE
|
10062N
|
R
|
N
|
Y
|
ORAL
| 3
| 15
| 2
| 1,040
|
JX
| 5
| 5
|
N
| 99.7
| 99.7
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,168
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2019-07-01
|
N
|
N
| 3,671
|
10064Q_8855_1373_5890_7176
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 400 mg in 20 mL
|
tocilizumab 400 mg/20 mL injection, 20 mL vial
|
Actemra
|
HB
|
10064Q
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 405.39
| 405.39
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10066T_13919_15597_30773_30775
|
Tobramycin
|
Tobramycin
|
Capsule containing powder for oral inhalation 28 mg (for use in podhaler)
|
tobramycin 28 mg powder for inhalation, 224 capsules
|
TOBI podhaler
|
GE
|
10066T
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 1
| 224
| 0
| 837
|
GO
| 224
| 224
|
N
| 2,282.85
| 2,282.85
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10067W_11574_1167_5317_38268
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Inflectra
|
HB
|
10067W
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 69
|
PF
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,396
|
a
|
N
| null | null | null |
N
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2015-12-01
|
N
|
Y
| 3,671
|
10067W_11574_1167_5317_41027
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Renflexis
|
HB
|
10067W
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 1,829
|
OQ
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,396
|
a
|
N
| null | null | null |
N
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2017-08-01
|
N
|
Y
| 3,671
|
10067W_11574_1167_5317_6278
|
Infliximab
|
Infliximab
|
Powder for I.V. infusion 100 mg
|
infliximab 100 mg injection, 1 vial
|
Remicade
|
HB
|
10067W
|
S
|
N
|
Y
|
INJECTION
| 5
| 5
| 1
| 63
|
JC
| 1
| 1
|
N
| 186.16
| 186.16
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| 20,396
|
a
|
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10068X_12337_1373_5891_7177
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 80 mg in 4 mL
|
tocilizumab 80 mg/4 mL injection, 4 mL vial
|
Actemra
|
HS
|
10068X
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 82.19
| 82.19
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10069Y_13910_30628_30629_30633
|
Panitumumab
|
Panitumumab
|
Solution concentrate for I.V. infusion 100 mg in 5 mL
|
panitumumab 100 mg/5 mL injection, 5 mL vial
|
Vectibix
|
IN
|
10069Y
|
S
|
N
|
Y
|
INJECTION
| null | null | 5
| 43
|
AN
| 1
| 1
|
N
| 450.42
| 450.42
|
Y
| 4
|
N
|
N
| null | null |
Y
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| 100
| 100
|
Y
|
mg
|
N
|
N
| 720
|
F1
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10069Y_13911_30628_30636_30638
|
Panitumumab
|
Panitumumab
|
Solution concentrate for I.V. infusion 400 mg in 20 mL
|
panitumumab 400 mg/20 mL injection, 20 mL vial
|
Vectibix
|
IN
|
10069Y
|
S
|
N
|
Y
|
INJECTION
| null | null | 5
| 43
|
AN
| 1
| 1
|
N
| 1,801.67
| 1,801.67
|
Y
| 4
|
N
|
N
| null | null |
Y
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| 400
| 400
|
Y
|
mg
|
N
|
N
| 720
|
F1
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-08-01
|
N
|
N
| 3,671
|
10071C_8853_1373_5889_7175
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 200 mg in 10 mL
|
tocilizumab 200 mg/10 mL injection, 10 mL vial
|
Actemra
|
HS
|
10071C
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 203.73
| 203.73
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10072D_8855_1373_5890_7176
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 400 mg in 20 mL
|
tocilizumab 400 mg/20 mL injection, 20 mL vial
|
Actemra
|
HB
|
10072D
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 405.39
| 405.39
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10073E_12337_1373_5891_7177
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 80 mg in 4 mL
|
tocilizumab 80 mg/4 mL injection, 4 mL vial
|
Actemra
|
HS
|
10073E
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 82.19
| 82.19
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10074F_13919_15597_30773_30775
|
Tobramycin
|
Tobramycin
|
Capsule containing powder for oral inhalation 28 mg (for use in podhaler)
|
tobramycin 28 mg powder for inhalation, 224 capsules
|
TOBI podhaler
|
GE
|
10074F
|
S
|
N
|
Y
|
INHALATION_BY_MOUTH
| 1
| 224
| 2
| 837
|
GO
| 224
| 224
|
N
| 2,282.85
| 2,282.85
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
Y
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10076H_14339_895_32226_32228
|
Nicotine
|
Nicotine
|
Transdermal patch 39.4 mg
|
nicotine 25 mg/16 hours patch, 28
|
nicorette 16hr Invisipatch
|
GE
|
10076H
|
R
|
N
|
Y
|
TRANSDERMAL
| 1
| 28
| 2
| 107
|
JT
| 28
| 28
|
N
| 35.23
| 35.23
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F1
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
N
| 3,671
|
10077J_12337_1373_5891_7177
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 80 mg in 4 mL
|
tocilizumab 80 mg/4 mL injection, 4 mL vial
|
Actemra
|
HB
|
10077J
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 82.19
| 82.19
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10078K_8855_1373_5890_7176
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 400 mg in 20 mL
|
tocilizumab 400 mg/20 mL injection, 20 mL vial
|
Actemra
|
HS
|
10078K
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 405.39
| 405.39
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
10079L_8853_1373_5889_7175
|
Tocilizumab
|
Tocilizumab
|
Concentrate for injection 200 mg in 10 mL
|
tocilizumab 200 mg/10 mL injection, 10 mL vial
|
Actemra
|
HS
|
10079L
|
A
|
N
|
Y
|
INJECTION
| 1
| 1
| 0
| 102
|
RO
| 1
| 1
|
N
| 203.73
| 203.73
|
N
| 4
|
N
|
N
| null | null |
N
|
N
| null | null |
N
| null | null | null |
Y
|
N
|
N
|
Y
| null | null | 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
injectable
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2014-04-01
|
N
|
Y
| 3,671
|
1007B_11093_129_1426_36966
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 90
|
Aciclovir Sandoz
|
GE
|
1007B
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 90
|
HX
| 90
| 25
|
N
| 16.92
| 4.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 19,702
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2015-06-01
|
N
|
N
| 3,671
|
1007B_11093_129_1426_45635
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 90
|
APO-Aciclovir
|
GE
|
1007B
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 72
|
TX
| 90
| 25
|
N
| 16.92
| 4.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 19,702
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2018-08-01
|
N
|
N
| 3,671
|
1007B_11093_129_1426_47933
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 90
|
Aciclovir APOTEX
|
GE
|
1007B
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 72
|
TY
| 90
| 25
|
N
| 16.92
| 4.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 19,702
|
a
|
N
| null |
2025-07-01
| null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null |
2025-04-01
| null |
2019-08-01
|
N
|
N
| 3,671
|
1007B_11093_129_1426_58260
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 90
|
ARX-ACICLOVIR
|
GE
|
1007B
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 1,908
|
XT
| 90
| 25
|
N
| 16.92
| 4.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 19,702
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2024-07-01
|
N
|
N
| 3,671
|
1007B_11093_129_1426_58629
|
Aciclovir
|
Aciclovir
|
Tablet 200 mg
|
aciclovir 200 mg tablet, 90
|
ACICLOVIR-WGR
|
GE
|
1007B
|
S
|
N
|
Y
|
ORAL
| 1
| 90
| 5
| 2,410
|
WG
| 90
| 25
|
N
| 16.92
| 4.7
|
N
| 20
|
Y
|
N
| null | null |
N
|
N
| 19,702
|
a
|
N
| null | null | null |
N
|
Y
|
Y
|
Y
| 4
| 6
| 12
| 12
| 12
| null | null |
N
| null |
N
|
N
| null |
F2
|
N
| null |
other
|
N
|
N
|
N
|
N
|
N
| null | null | null | null | null | null |
2024-09-01
|
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