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Annex 1: Examples of applications resulting in a new strength or a variation

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Examples Strength (for classification of category of application only) New Strength or Variation
Solid - Single-dose
1. Tablets from 100 mg 100 mg

New strength
(Major variation)
to 500 mg 500 mg
2. Granules (sachet) from 1 g 1 g

New strength
(Major variation)
to 2 g 2 g
Solid - Multi-dose
3. Granules (bottle) from 100 mg/5 g (spoon) 20 mg/g

New strength
(Major variation)
to 500 mg/5 g 100 mg/g
from 500 g bottle (of 100 mg/g) 100 mg/g Variation
(New pack size)
to 1000 g bottle (of 100 mg/g) 100 mg/g
Solid - Fixed combinations/combination packs
4. Tablets (fixed combination) from 5 mg X + 10 mg Y 5 mg + 10 mg

New strength
(Major variation)
to 10 mg X + 20 mg Y 10 mg + 20 mg
from 5 mg X + 10 mg Y 5 mg + 10 mg

New strength
(Major variation)
to 5 mg X + 20 mg Y 5 mg + 20 mg
Semi-solid - Multi-dose
5. Gel from 20 mg/g 20 mg/g

New strength
(Major variation)
to 100 mg/g 100 mg/g
from 20 g jar (of 100 mg/g) 100 mg/g

Variation
(New pack size)
to 30 g jar (of 100 mg/g) 100 mg/g
Powder for oral solution/suspension - Single-dose
6. Powder for oral solution (sachet) from 100 mg (to 2 mL) 100 mg

New strength
(Major variation)
to 200 mg (to 2 mL) 200 mg
from 100 mg (to 2 mL) 100 mg

New strength
(Major variation)
to 200 mg (to 4 mL) 200 mg
Powder for oral solution/suspension - Multi-dose
7. Powder for oral suspension (bottle) from

10 g (to 200 mL)

 50 mg/mL

New strength
(Major variation)
to 20 g (to 200 mL) 100 mg/mL
from 10 g (to 200 mL)

50 mg/mL

Variation
(New pack size)
to 20 g (to 400 mL) 50 mg/mL
Liquid ready-to-use - Single-dose
8. Oral solution (sachet) from 100 mg/5 mL 100 mg

New strength
(Major variation)
to 200 mg/5 mL 200 mg
from 100 mg/5 mL 100 mg

New strength
(Major variation)
to 200 mg/10 mL 200 mg
Liquid ready-to-use - Multi-dose
9. Oral solution (bottle) from 500 mg/50 mL 10 mg/mL

New strength
(Major variation)
to 1000 mg/50 mL 20 mg/mL
from 500 mg/50 mL 10 mg/mL

Variation
(New pack size)
to 1000 mg/100 mL 10 mg/mL
Liquid ready-to-use - Single-dose
10. Solution for injection (example, pre-filled syringe) from 100 mg/1 mL

100 mg

New strength
(Major variation)
to 200 mg/1 mL 200 mg
from 100 mg/1 mL 100 mg

New strength
(Major variation)
to 200 mg/2 mL 200 mg
from

100 mg/1 mL

100 mg

Variation
(New formulation)
to 100 mg/0.5 mL 100 mg
Liquid ready-to-use - Multi-dose
11. Solution for injection (example, hospital pharmacy bulk pack) from 500 mg/50 mL 10 mg/mL

New strength
(Major variation)
to 1000 mg/50 mL 20 mg/mL
from 500 mg/10 mL 50 mg/mL

Variation
(New pack size)
to 1000 mg/20 mL 50 mg/mL
Powder for reconstitution
12. Powder for solution for injection from 100 mg (to 2 mL) 100 mg

New strength
(Major variation)
to 200 mg (to 2 mL) 200 mg
from 100 mg (to 2 mL) 100 mg

New strength
(Major variation)
to 200 mg (to 4 mL) 200 mg
Cutaneous Semi-solid - Multi-dose
13. Cream from 20 mg/g 20 mg/g

New strength
(Major variation)
to

100 mg/g
(sachet)

 100 mg/g
from 20 mg/g 20 mg/g Variation
to

40 mg/2g
(sachet)

 20 mg/g
from 20 g tube (of 100 mg/g) 100 mg/g

Variation
(New pack size)
to 30 g tube (of 100 mg/g) 100 mg/g
Eye preparations, liquid ready-to-use - Single-dose
14. Eye drops, Solution from 10 mg/0.5 mL 10 mg

New strength
(Major variation)
to 20 mg/0.5 mL 20 mg
Eye preparations, liquid ready-to-use - Multi-dose
15. Eye drops, Solution from 50 mg/5 mL 10 mg/mL

New strength
(Major variation)
to 100 mg/5 mL 20 mg/mL
from 50 mg/ 5 mL 10 mg/mL

Variation
(New pack size)
to 100 mg/ 10 mL 10 mg/mL
Transdermal patch
16. Transdermal patch from 2 mg 25 µg/ 24 h

New strength
(Major variation)
to 3 mg 30 µg/ 24 h
from 2 mg 25 µg/ 24 h

Variation
to 2.5 mg 25 µg/ 24 h
Liquid ready-to-use - Multi-dose
17. Pressurised inhalation solution from 5 mg/ puff 5 mg/ puff

New strength
(Major variation)
to 10 mg/ puff 10 mg/ puff
from 60 puffs 5mg/ puff

Variation
(Cat 3 - new pack size)
to

100 puffs per container
(of 5 mg/ puff)

 5mg/ puff
Powder - Single-dose
18. Inhalation powder, hard capsule from 1 mg 1 mg/ puff

New strength
(Major variation)
to 2 mg 2 mg/ puff
Powder - Multi-dose
19. Inhalation powder from 6 mg/ puff 6 mg/ puff

New strength
(Major variation)
to 12 mg/ puff 12 mg/ puff
from

60 puffs

6mg/ puff

Variation
(New pack size)
to

100 puffs per container
(of 6 mg/ puff)

 6mg/ puff
(Semi)-solid, liquid ready-to-use - Single-dose
20. Suppository from 100 mg 100 mg

New strength
(Major variation)
to 200 mg 200 mg
(Semi)-solid, liquid ready-to-use - Multi-dose
21. Vaginal cream from 20 mg/g 20 mg/g

New strength
(Major variation)
to 100 mg/g 100 mg/g
from 20 g tube (of 100 mg/g) 100 mg/g

Variation
(New pack size)
to 30 g tube (of 100 mg/g) 100 mg/g

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