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Dupixent 200 mg solution for injection in pre-filled syringe

  • Name:

    Dupixent 200 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Dupilumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/20

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Summary of Product Characteristics last updated on medicines.ie: 4/5/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 May 2020 PIL

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 4 May 2020 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 November 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 October 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

3.       PHARMACEUTICAL FORM

 

Solution for injection (injection)

 

Clear to slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of excipients

 

arginine hydrochloride

histidine

polysorbate 80 (E433)

sodium acetate trihydrate

glacial acetic acid (E260)

sucrose

water for injections

 

6.5     Nature and contents of container

 

1.14 ml solution in a siliconised type-1 clear glass pre-filled syringe with needle shield or pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.

 

Dupixent 200 mg solution for injection in pre-filled syringe

1.14 ml solution in a siliconised type-1 clear glass pre-filled syringe with needle shield  or pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.

 

Pack size:

  • 1 pre-filled syringe
  • 2 pre-filled syringes
  • Multipack containing 3 (3 packs of 1) pre-filled syringes
  • Multipack containing 6 (3 packs of 2) pre-filled syringes

 

Dupixent 200 mg solution for injection in pre-filled pen

1.14 ml solution in a siliconised type-1 clear glass syringe in a pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.

 

Pack size:

 

Updated on 12 September 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 September 2019 PIL

Reasons for updating

  • New PIL for new product