Hulio 40 mg solution for injection in pre-filled syringe * Pharmacy Only: Prescription
Company:
Gerard LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 28 September 2022
File name
633424c2d151b.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 28 September 2022
File name
633420fc62cee.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 28 September 2022
File name
633420b84e0b1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to restricted prescription (C)
Updated on 28 September 2022
File name
6334129ab82f8.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to restricted prescription (C)
Updated on 24 November 2021
File name
ie-pil-h-4429-en-clean-vmaht-syringe_1637749216.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 24 November 2021
File name
ie-spc-h-4429-en-clean-vmaht-syringe_1637749179.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 19 October 2021
File name
ie-spc-h-4429-en-clean-v032(pack sizes-alcohol pads)_1634639931.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to restricted prescription (C)
Updated on 28 June 2021
File name
ie-spc-v027 - pen-syringe_1624891293.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 24 May 2021
File name
ie-spc-v026 - syringe_1621890965.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to restricted prescription (C)
Updated on 24 May 2021
File name
ie-pl-v026-syringe_1621890315.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 22 March 2021
File name
Hulio 40mg solution for injection in pre filled syringe_1616409564.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 January 2021
File name
Hulio 40 mg solution for injection in pre-filled syringe SPC_1609765206.pdf
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 04 January 2021
File name
Hulio 40 mg solution for injection in pre-filled syringe PIL_1609765167.pdf
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
File name
Hulio 40mg sol for inj prefilled syringe SPC_1603453535.pdf
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
File name
Hulio 40mg sol for inj prefilled syringe PIL_1603453457.pdf
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
File name
ie-40mg sol for inj in prefilled syringe-h-4429-en-clean-v015_1586526952.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 06 March 2020
File name
Hulio 40mg solution for injection prefilled syringe & pen v0015_1583505251.pdf
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
File name
Hulio 40mg sol for injection prefilled syringe_1572350604.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
Hulio 40mg sol for injection in prefilled syringe_1555073825.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
ie-SPC-h-4429-en-clean-v007_1555073855.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 17 January 2019
File name
40mg syringe PIL_1547727632.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 January 2019
File name
40mg pen & syringe SPC_1547727759.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 23 October 2018
File name
Hulio Package leaflet for Syringe_1540303236.pdf
Reasons for updating
- New PIL for new product
Updated on 23 October 2018
File name
Hulio Combined Smpc Pen plus Syringe_1540303278.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)