Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: PTC Therapeutics International Limited, 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland
Translarna 125 mg granules for oral suspension.
Translarna 250 mg granules for oral suspension.
Translarna 1000 mg granules for oral suspension.
| Pharmaceutical Form |
|---|
|
Granules for oral suspension. White to off-white granules. |
Translarna 125 mg granules for oral suspension: Each sachet contains 125 mg ataluren.
Translarna 250 mg granules for oral suspension: Each sachet contains 250 mg ataluren.
Translarna 1000 mg granules for oral suspension: Each sachet contains 1000 mg ataluren.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ataluren |
A nonsense mutation in DNA results in a premature stop codon within an mRNA. This premature stop codon in the mRNA causes disease by terminating translation before a full-length protein is generated. Ataluren enables ribosomal readthrough of mRNA containing such a premature stop codon, resulting in production of a full-length protein. |
| List of Excipients |
|---|
|
Polydextrose (E1200) |
Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (colouring and polyester/foil bond), aluminium foil (moisture barrier), adhesive (polyurethane class), copolymer of ethylene and methacrylic acid (sealant resin for packaging integrity).
Pack of 30 sachets.
PTC Therapeutics International Limited, 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland
Translarna 125 mg granules for oral suspension: EU/1/13/902/001
Translarna 250 mg granules for oral suspension: EU/1/13/902/002
Translarna 1000 mg granules for oral suspension: EU/1/13/902/003
Date of first authorisation: 31 July 2014
Date of latest renewal: 23 July 2020
| Drug | Countries | |
|---|---|---|
| TRANSLARNA | Austria, Brazil, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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