ZTALMY Oral suspension Ref.[51076] Active ingredients: Ganaxolone

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Marinus Pharmaceuticals Emerald Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Product name and form

ZTALMY 50 mg/mL oral suspension.

Pharmaceutical Form

Oral suspension.

White to off-white suspension.

Qualitative and quantitative composition

Each mL of oral suspension contains 50 mg of ganaxolone.

Excipients with known effect:

Each mL of oral suspension contains:

  • 0.92 mg of sodium benzoate
  • 0.00068 mg benzoic acid
  • 0.00023 mg benzyl alcohol
  • 1.02 mg methyl parahydroxybenzoate
  • 0.2 mg propyl parahydroxybenzoate

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ganaxolone

Ganaxolone is a methyl analogue of the endogenous neurosteroid allopregnanolone. Ganaxolone is a neuroactive steroid that positively and allosterically modulates gamma-aminobutyric acid type A (GABAA) receptors in the CNS by interacting with a recognition site that is distinct from other allosteric GABAA receptor modulators. Its anticonvulsant effects are thought to result from this modulation of GABAA receptor function providing constant, or tonic, modulation of GABA-mediated inhibitory neurotransmission.
List of Excipients

Hypromellose (E464)
Polyvinyl alcohol (E1203)
Sodium lauryl sulfate (E487)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Sodium benzoate (E211)
Citric acid, anhydrous (E330)
Sodium citrate dihydrate (E311)
Artificial cherry flavour (including propylene glycol [E1520] and benzyl alcohol [E1519])
Sucralose (E955)
Simethicone emulsion (simethicone, polysorbate 65, methylcellulose, polyethylene glycolmonostearate, glycerol monostearate, xanthan gum, benzoic acid [E210], sorbic acid, and purified water)
Purified water

Pack sizes and marketing

High-density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant (CR) cap lined with an induction foil liner packed into a carton along with calibrated reusable oral dosing syringes (HDPE plunger and polypropylene barrel), and a bottle adaptor(s) (low-density polyethylene).

Each carton contains either:

  • one 110 mL-bottle with two 3 mL oral dosing syringes, two 12 mL oral dosing syringes, and one bottle adaptor, or
  • five 110 mL-bottles with five 12 mL oral dosing syringes, and five bottle adaptors.

Each 12 mL syringe is graduated in 0.25 mL increments and each 3 mL syringe is graduated in 0.1 mL increments.

Not all pack sizes may be marketed.

Marketing authorization holder

Marinus Pharmaceuticals Emerald Limited, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

Marketing authorization dates and numbers

EU/1/23/1743/001
EU/1/23/1743/002

Drugs

Drug Countries
ZTALMY Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States
 
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