Ogivri 150 mg powder for concentrate for solution for infusion * 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 10 August 2023
File name
64d4c966caa0f.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 10 August 2023
File name
64d4c8967686a.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 4.6 - 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Updated on 28 October 2021
File name
ie-spc-h4916-150mg-v037-clean_1635410868.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 28 October 2021
File name
ie-spc-h4916-150mg-v037-clean_1635410150.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 24 August 2021
File name
ie-pl-h4916-t0034-clean_1629817557.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 August 2021
File name
ie-spc-h4916-150mg-t0034-clean_1629817453.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 10 August 2021
File name
ie-spc-h4916-150mg-v035-clean_1628600507.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 10 August 2021
File name
ie-pl-h4916-v035-clean_1628600348.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Change to storage instructions
Updated on 23 March 2021
File name
ie-spc-h4916-150mg-v026-clean_1616516577.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 23 March 2021
File name
ie-pl-h4916-v026-clean_1616516546.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to storage instructions
Updated on 07 February 2020
File name
ie-spc-h4916-150mg-v010-clean_1581068645.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 07 February 2020
File name
ie-pl-h4916-v010-clean_1581068622.pdf
Reasons for updating
- New PIL for new product