Ethambutol Hydrochloride/ Isoniazid/Pyrazinamide/ Rifampicin 275 mg/75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

WHOPAR Part 5

LABELLING

Page 1 of 6

January 2023

WHOPAR Part 5

Ethambutol Hydrochloride/ Isoniazid/
Pyrazinamide/ Rifampicin 275 mg/75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

January 2023

PARTICULARS TO APPEAR ON THE OUTER PACKAGINGHDPE Bottle Label
1. Name of the medicinal product[TB193 trade name]1Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin275 mg/75 mg/400 mg/150 mg tablets
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin
2. Statement of active substance
Each tablet contains 275 mg ethambutol hydrochloride, 75 mg isoniazid, 400 mg pyrazinamide and150 mg rifampicin.
3. List of excipients
See patient information leaflet for further information
4. Pharmaceutical form and contents
1000 tablets
5. Method and route of administration
Oral use
Read the patient information leaflet before use.
6. Special warning that the medicinal product must be stored out of the reach and sight ofchildren
Keep out of the sight and reach of children.
7. Other special warning(s), if necessary

8. Expiry date
EXP {MM/YYYY}
9. Special storage conditions
Do not store above 30°C. Protect from light. Store in a dry place.
10. Special precautions for disposal of unused medicinal products or waste materials derived
from such medicinal products, if appropriate

11. Name and address of the supplier
Svizera Europe BV
1

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
Page 2 of 6

Ethambutol Hydrochloride/ Isoniazid/
Pyrazinamide/ Rifampicin 275 mg/
75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

WHOPAR Part 5

Antennestraat 84P.O. Box 60300
1320 AS Almere
The Netherlands
Tel: +31 (0) 36 5397 340
Fax:+31 (0) 36 5397 349
E-mail: info@svizera.org
12. WHO Reference Number (Prequalification Programme)
TB193
13. Manufacturer’s batch number<Batch> {number}
14. (Advice on) General classification for supply
Medicinal product subject to medical prescription.
15. Instructions on use

Page 3 of 6

January 2023

WHOPAR Part 5

Ethambutol Hydrochloride/ Isoniazid/
Pyrazinamide/ Rifampicin 275 mg/
75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

January 2023

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Carton label for blister pack1. Name of the medicinal product[TB193 trade name]2 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin 275 mg/75 mg/400 mg/150 mg tablets
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin
2. Statement of active substance
Each tablet contains 275 mg ethambutol hydrochloride, 75 mg isoniazid, 400 mg pyrazinamide and150 mg rifampicin.
3. List of excipients
See patient information leaflet for further information
4. Pharmaceutical form and contents
24 x 28 tablets
5. Method and route of administration
Oral use
Read the patient information leaflet before use.
6. Special warning that the medicinal product must be stored out of the reach and sight ofchildren
Keep out of the sight and reach of children.
7. Other special warning(s), if necessary

8. Expiry date
EXP {MM/YYYY}
9. Special storage conditions
Do not store above 30°C. Protect from light. Store in a dry place
10. Special precautions for disposal of unused medicinal products or waste materials derived
from such medicinal products, if appropriate

11. Name and address of the supplier
Svizera Europe BV
2

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
Page 4 of 6

Ethambutol Hydrochloride/ Isoniazid/
Pyrazinamide/ Rifampicin 275 mg/
75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

WHOPAR Part 5

Antennestraat 84
P.O. Box 60300
1320 ASAlmere
The Netherlands
Tel: +31 (0) 36 5397 340
Fax:+31 (0) 36 5397 349
E-mail: info@svizera.org
12. WHO Reference Number (Prequalification Programme)
TB193
13. Manufacturer’s batch number<Batch> {number}
14. (Advice on) General classification for supply
Medicinal product subject to medical prescription.
15. Instructions on use

Page 5 of 6January 2023

Ethambutol Hydrochloride/ Isoniazid/Pyrazinamide/ Rifampicin 275 mg/75 mg /400 mg/150 mg Tablets(Svizera Europe BV), TB193

WHOPAR Part 5

January 2023

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1. Name of the medicinal product[TB193 trade name]3 Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin 275 mg/75 mg/
400 mg/150 mg tablets
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin
2. Name of the supplier
SvizeraEurope BV
3. Expiry date
EXP {MM/YYYY}
4. Manufacturer’s batch number<Batch> {number}3

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
Page 6 of 6