Zithromax Powder for Oral Suspension 200 mg/5 ml
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 17 October 2024
File name
Reg PIL ZX 33_0 POS IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 17 October 2024
File name
Reg SPC ZX 36_0 POS IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 Change of MAH name and address
Updated on 26 June 2023
File name
Reg SPC ZX 35_1 POS IE clean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2023
File name
Reg PIL ZX 32_1 POS IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202102575_Reg SPC ZX 33_2 POS IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2021
File name
DEC202102575_Reg SPC ZX 33_2 POS IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 January 2021
File name
DEC202102575_Reg PIL ZX 30_2 POS IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 May 2019
File name
DEC201928045_Reg SPC ZX 32_1 POS IE_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2019
File name
DEC201917487_Reg PIL ZX 29_1 POS IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 April 2019
File name
DEC201917487_Reg SPC ZX 31_1 POS IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 4.8 DRESS frequency has been corrected from Very Rare to Rare
Updated on 30 October 2018
File name
Reg SPC ZX 30_1 POS IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: |
Updated on 25 October 2018
File name
Reg PIL ZX 28_1 POS IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 23 July 2018
File name
Reg SPC ZX 29_0 POS IE clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
4.6. Fertility, pregnancy and lactation
Subsection on breast-feeding updated in line with CDS.
Updated on 15 May 2018
File name
Reg_SPC_ZX_28_0_POS_IE_Clean.docx
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2018
File name
Reg_SPC_ZX_28_0_POS_IE_Clean.docx
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
4.5. Interactions with other medicinal products and other forms of interaction
Inclusion of colchicine
Updated on 08 May 2018
File name
Reg PIL ZX 27_0 POS IE clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 17 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 July 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 July 2017
File name
PIL_9061_269.pdf
Reasons for updating
- New PIL for new product
Updated on 14 July 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 April 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.
Updated on 20 April 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 08 March 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.
Updated on 07 March 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 14 January 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.8 of the SmPC has been updated to add the Adverse Drug Reaction ‘DRESS’ and consequentially the Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity reactions.
Updated on 12 January 2016
Reasons for updating
- Change of trade or active ingredient name
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 16 December 2014
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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Section 4.2 of the SmPC has been updated to add text relating to use in the elderly.
· Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity, hepatotoxicity. In addition an enhanced precautionary text on prolongation of the QT interval has been added.
· Section 4.5 of the SmPC has been updated to add precautionary text for Digoxin and to add text for
· Atorvastin.
· Section 4.6 ofthe SmPC has been updated to add text pertaining to breast milk and fertility.
· Section 4.8 of the SmPC has been updated to add the Adverse Drug Reactions 'deafness', 'tinnitus' and 'hearing impaired' to the Post-marketing subsection.
· Section 5.1 of the SmPC now includes updated text on microbiology information.
· Section 4.4 of the SmPC has been updated to draw attention to the possible fatal issue of QT prolongation
· Section 5.1 of the SmPC now includes updated text on cardiac electrophysiology with regards to co-administration of azithromycin and chloroquine.
To align with CSP
Updated on 09 December 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 25 June 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 June 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Change to dosage and administration
Updated on 02 April 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 July 2012
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
Updated on 22 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 05 February 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 03 November 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 September 2007
Reasons for updating
- Change of special precautions for disposal
Updated on 30 July 2007
Reasons for updating
- Change of trade or active ingredient name
- Change to storage instructions
- Change to date of revision
- Change from the BAN of the active substance to the rINN
Updated on 26 October 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 30 September 2004
Reasons for updating
- New PIL for medicines.ie
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363