Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
Lojuxta 5 mg hard capsules.
Lojuxta 10 mg hard capsules.
Lojuxta 20 mg hard capsules.
Lojuxta 30 mg hard capsules.
Lojuxta 40 mg hard capsules.
Lojuxta 60 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard, capsule. Lojuxta 5 mg hard capsules: The capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap. Lojuxta 10 mg hard capsules: The capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap. Lojuxta 20 mg hard capsules: The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap. Lojuxta 30 mg hard capsules: The capsule is an orange cap/yellow body hard capsule of 21.6 mm, printed with black ink imprinted with “30 mg” on body and “A733” on cap. Lojuxta 40 mg hard capsules: The capsule is a yellow cap/white body hard capsule of 23.4 mm, printed with black ink imprinted with “40 mg” on body and “A733” on cap. Lojuxta 60 mg hard capsules: The capsule is a yellow cap/yellow body hard capsule of 23.4 mm, printed with black ink imprinted with “60 mg” on body and “A733” on cap. |
Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).
Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Excipient with known effect:
Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lomitapide |
Lomitapide directly binds and inhibits microsomal triglyceride transfer protein (MTP), which resides in the lumen of the endoplasmic reticulum, thereby preventing the assembly of apo B-containing lipoproteins in enterocytes and hepatocytes. This inhibits the synthesis of chylomicrons and VLDL. The inhibition of the synthesis of VLDL leads to reduced levels of plasma LDL-C. |
| List of Excipients |
|---|
|
Capsule content: Pregelatinised starch (maize) Capsule shell: Lojuxta 5 mg, 10 mg hard capsules: Gelatin Lojuxta 20 mg hard capsules: Gelatin Lojuxta 30 mg hard capsules: Gelatin Lojuxta 40 mg, 60 mg hard capsules: Gelatin Printing ink: Shellac |
High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.
Package sizes are: 28 capsules.
Amryt Pharmaceuticals DAC, 45 Mespil Road, Dublin 4, Ireland
EU/1/13/851/001 – Lojuxta 5 mg hard capsules
EU/1/13/851/002 – Lojuxta 10 mg hard capsules
EU/1/13/851/003 – Lojuxta 20 mg hard capsules
EU/1/13/851/004 – Lojuxta 30 mg hard capsules
EU/1/13/851/005 – Lojuxta 40 mg hard capsules
EU/1/13/851/006 – Lojuxta 60 mg hard capsules
Date of first authorisation: 31 July 2013
Date of latest renewal: 23 April 2018
| Drug | Countries | |
|---|---|---|
| LOJUXTA | Austria, Brazil, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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