Hulio 40 mg/0.8 ml solution for injection * Pharmacy Only: Prescription
Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 September 2023
File name
6509822b3bc30.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 19 September 2023
File name
650981ce61e16.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 7 - Marketing authorisation holder
- Removal of Black Inverted Triangle
Legal category:Product subject to restricted prescription (C)
Updated on 28 September 2022
File name
6334253548753.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
633424fc19307.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-solution_1637749406.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 -solution_1637749370.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 25 May 2021
File name
ie-pl-v026-vial_1621927165.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 May 2021
File name
ie-spc-v026-vial_1621892121.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-vial_1621891796.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_0.8ml solution for injection_1616409727.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_0.8 mL solution for injection SPC_1609764908.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_0.8 mL solution for injection PIL_1609764665.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_0.8ml sol for inj SPC_1603453717.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_0.8ml sol for inj PIL_1603453690.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 injection-h-4429-en-clean-v015-2_1586526773.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 06 March 2020
File name
Hulio 40mg_0.8ml solution for injection v0015_1583505423.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_0.8ml sol for injection_1572350696.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 August 2019
File name
ie-pl-h-4429-en-clean-v007 (002)_1565691641.pdf
Reasons for updating
- New PIL for new product
Updated on 13 August 2019
File name
ie-spc-h-4429-en-clean-v007_1565691664.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)