Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin, D15 AKK1, Ireland e-mail: info@amicusrx.co.uk
Pombiliti 105 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to slightly yellowish lyophilised powder. |
One vial contains 105 mg of cipaglucosidase alfa.
After reconstitution of each vial (see section 6.6), the concentrated solution contains 15 mg of cipaglucosidase alfa* per mL.
* Human acid α-glucosidase with bis-phosphorylated N-glycans (bis-M6P) is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.
Excipient with known effect: Each vial contains 10.5 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cipaglucosidase alfa |
Sipaglucosidase alfa is intended to replace the endogenous enzyme acid-alpha-glucosidase (GAA) that breaks down glycogen to glucose in the lysosome and is absent or impaired in Pompe disease. Sipaglucosidase alfa exerts enzymatic activity in the breakdown of glycogen and the reduction of intramuscular glycogen, as well as the amelioration of tissue damage. |
| List of Excipients |
|---|
|
Sodium citrate dihydrate (E331) |
105 mg of powder for concentrate for solution for infusion in a 20 mL neutral borosilicate clear Type I glass vial sealed with 20 mm chlorobutyl rubber stopper and with an aluminium over seal with dark grey plastic button.
Packs containing 1, 10, and 25 vials.
Not all pack sizes may be marketed.
Amicus Therapeutics Europe Limited, Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin, D15 AKK1, Ireland
e-mail: info@amicusrx.co.uk
EU/1/22/1714/001
EU/1/22/1714/002
EU/1/22/1714/003
| Drug | Countries | |
|---|---|---|
| POMBILITI | Austria, Spain, France, Ireland, Lithuania, Poland, United Kingdom |
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