LEVOTHYROXINE Oral solution Ref.[6943] Active ingredients: Levothyroxine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA

Product name and form

Levothyroxine 25 micrograms/5ml Oral Solution.

Pharmaceutical Form

Oral Solution.

Clear colourless, odourless solution.

Qualitative and quantitative composition

Each 5ml of oral solution contains 25 micrograms levothyroxine sodium.

Excipients with known effect:

Sodium methyl parahydroxybenzoate (E219): 10 mg per 5ml dose.

Glycerol: 3,780 mg per 5ml dose.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Levothyroxine

Levothyroxine sodium is used for the treatment of hypothyroidism. The chief action of levothyroxine is to increase the rate of cell metabolism.

List of Excipients

Glycerol
Citric acid anhydrous
Sodium methyl parahydroxybenzoate (E219)
Citric acid 10%
Purified water

Pack sizes and marketing

Levothyroxine oral solution is packed in amber (Type III) glass bottle 100 ml, with child-resistant, tamper-evident screw cap with an LDPE liner, a 5ml graduated oral dosing syringe and a “press-in” syringe/bottle adaptor.

Marketing authorization holder

Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield, County Durham, NE16 6EA

Marketing authorization dates and numbers

PL 41344/0031

24/10/2016

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