Hulio 40 mg/0.8 ml solution for injection | SPC | Gerard Laboratories

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Hulio 40 mg/0.8 ml solution for injection

Name:
Hulio 40 mg/0.8 ml solution for injection
Company:
Gerard Laboratories
Active Ingredients:
adalimumab
Legal Category:
Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/03/21

Summary of Product Characteristics last updated on medicines.ie: 4/1/2021

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 22 March 2021 PIL

Reasons for updating

Change to section 6 - manufacturer
Change to section 6 - date of revision

Updated on 4 January 2021 SPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition
Change to section 4.2 - Posology and method of administration
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.2 - Pharmacokinetic properties
Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 4 January 2021 PIL

Reasons for updating

Change to Section 1 - what the product is
Change to section 1 - what the product is used for
Change to section 2 - what you need to know - warnings and precautions
Change to section 2 - use in children and adolescents
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - pregnancy, breast feeding and fertility
Change to section 2 - driving and using machines
Change to section 3 - use in children/adolescents
Change to section 4 - possible side effects
Change to section 6 - what the product contains
Change to section 6 - date of revision

Updated on 23 October 2020 SPC

Reasons for updating

Change to section 4.8 - Undesirable effects
Change to Section 4.8 – Undesirable effects - how to report a side effect
Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 23 October 2020 PIL

Reasons for updating

Change to section 4 - possible side effects
Change to section 4 - how to report a side effect
Change to section 6 - date of revision

Updated on 10 April 2020 PIL

Reasons for updating

Change to section 4 - how to report a side effect

Updated on 6 March 2020 SPC

Reasons for updating

Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 29 October 2019 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 13 August 2019 PIL

Reasons for updating

New PIL for new product

Updated on 13 August 2019 SPC

Reasons for updating

New SPC for new product

Legal category: Product subject to restricted prescription (C)