Clarithromycin 500 mg, Powder for Concentrate for Solution for Infusion
*Company:
ADVANZ PharmaStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 September 2024
File name
Clarithromycin 500mg, powder for concentrate for solution for infusion_PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- 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 16 September 2024
File name
Clarithromycin 500mg Powder for Concentrate for Solution for Infusion_SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- Change to section 6.4 - Special precautions for storage
- 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 medical prescription which may not be renewed (A)
Updated on 09 September 2024
File name
Clarithromycin 500mg, powder for concentrate for solution for infusion_PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 09 September 2024
File name
Clarithromycin 500mg Powder for Concentrate for Solution for Infusion_SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- Change to section 6.4 - Special precautions for storage
- 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 medical prescription which may not be renewed (A)
Updated on 16 December 2021
File name
Clarithromycin Pdr for concn for soln for infus 500mg_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 07 October 2021
File name
CLARIT~2.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Description of Change: DCP Type II Grouped Variation Application (Please note approval received for IE is on 09 Sep 21). Approval date mentioned as per EOP.
Updated on 28 May 2021
File name
Clarithromycin Powder for concn for soln for inf 500 mg_SPC_IE.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update SmPC section 4.3, 4.4, 4.5, 4.6 and PIL sections 2 in line with the recommendation received from CMDh with the scientific conclusion made by the PRAC.
Updated on 05 July 2019
File name
190315 SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)