Hulio 40 mg solution for injection in pre-filled syringe
Product Information *
Company:
Gerard LaboratoriesStatus:
No Recent UpdateActive Ingredients :
This medicinal product is subject to additional monitoring.
*Additional information is available upon request
Legal Category:
Product subject to restricted prescription (C)
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 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)