01 3Biogen
02 106F. Hoffmann-La Roche
03 5Fresenius Kabi AB Brunna
04 4Fresenius Kabi USA
05 4Genentech
06 2Health Biotech
01 3INF
02 3INJECTABLE; INJECTION
03 3INJECTABLE;INJECTION
04 3INJECTABLE;INTRAVENOUS
05 1INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
06 1INJECTABLE;SUBCUTANEOUS
07 1INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
08 2Inf Conc
09 1Inf Konz
10 2Inj L?s
11 2Injection
12 1KONCENTRAT TILL INFUSIONSVÄTSKA, LÖSNING
13 1PFS
14 5SOLUTION
15 3Solution for infusion
16 1Solution for injection in a pre-filled pen
17 1Solution for injection, solution in pre-filled syringe
18 90Blank
01 4Originator
02 5Prescription
03 115Blank
01 9ACTEMRA
02 59Actemra
03 1Actemra 200
04 1Actemra 400
05 1Actemra 80
06 18Actemra ACTPen
07 1Actemra SC
08 18Actemra Subcutaneous Injection
09 2RoActemra
10 3TOFIDENCE
11 4TYENNE
12 5Tyene
13 2Blank
01 90Australia
02 5Canada
03 2India
04 5Norway
05 4South Africa
06 2Sweden
07 5Switzerland
08 11USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TOFIDENCE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 761354
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : RoActemra
Dosage Form : KONCENTRAT TILL INFUSIONSVÄTSKA, LÖSNING
Dosage Strength : 20 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : RoActemra
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA
Dosage Strength : 162 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Actemra
Dosage Form : Inf Conc
Dosage Strength : 200mg/10ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Actemra
Dosage Form : Inf Conc
Dosage Strength : 400mg/20ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Actemra
Dosage Form : Inf Konz
Dosage Strength : 80mg/4ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Actemra
Dosage Form : Inj L?s
Dosage Strength : 162mg/0.9ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Actemra
Dosage Form : Inj L?s
Dosage Strength : 162mg/0.9ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ACTEMRA
Dosage Form : SOLUTION
Dosage Strength : 162MG/0.9ML
Packaging : 4 AUTOINJECTORS
Approval Date :
Application Number : 2483327
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ACTEMRA
Dosage Form : SOLUTION
Dosage Strength : 162MG/0.9ML
Packaging : 4 PFS
Approval Date :
Application Number : 2424770
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ACTEMRA
Dosage Form : SOLUTION
Dosage Strength : 80MG/4ML
Packaging : 4X4ML
Approval Date :
Application Number : 2350092
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ACTEMRA
Dosage Form : SOLUTION
Dosage Strength : 200MG/10ML
Packaging : 4X10ML
Approval Date :
Application Number : 2350106
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ACTEMRA
Dosage Form : SOLUTION
Dosage Strength : 400MG/20ML
Packaging : 4X20ML
Approval Date :
Application Number : 2350114
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for injection, solution in pre-filled syringe
Dosage Strength : 162 mg
Packaging : Pre-filled glass syringe 4 0.9ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 162 mg
Packaging : Pre-filled pen 4 0.9ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for infusion
Dosage Strength : 20 mg/ml
Packaging : Vials 1 4ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for infusion
Dosage Strength : 20 mg/ml
Packaging : Vials 1 20ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Tyene
Dosage Form : Solution for infusion
Dosage Strength : 20 mg/ml
Packaging : Vials 1 10ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 162MG/0.9ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : TYENNE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 761275
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 80MG/4ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 125276
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ACTEMRA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 162MG/0.9ML
Packaging :
Approval Date :
Application Number : 125472
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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