Hulio 40 mg solution for injection in pre-filled pen
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_1624891327.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 - pen_1621891518.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Updated on 24 May 2021
File name
ie-pl-v026-pen_1621891243.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 pen_1616409609.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 pen SPC_1609765099.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 pen PIL_1609765060.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 pen SPC_1603453653.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 pen PIL_1603453614.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 06 March 2020
File name
Hulio 40mg solution for injection prefilled syringe & pen v0015_1583505362.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
Huilio 40mg sol for injection prefilled pen_1572350656.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 pen_1555073790.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_1555072432.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 pen PIL_1547727276.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- 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_1547727339.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 Pen_1540303358.pdf
Reasons for updating
- New PIL for new product
Updated on 23 October 2018
File name
Hulio Combined Smpc Pen plus Syringe_1540303391.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)