Distaclor 125mg/5ml Granules for Oral Suspension
- Name:
Distaclor 125mg/5ml Granules for Oral Suspension
- Company:
Flynn Pharma Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/02/18
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Flynn Pharma Ltd
Company Products
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 12 March 2018 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 28 February 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 5 February 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 5 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 10 January 2018 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 16 August 2016 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2012 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4- "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase - isomaltaseinsufficiency should not take this medicine."- added
In section 9- date of last renewal is changed to "16th june 2008"
in section 10- date of revision of text is changed to "august 2009"
Updated on 14 March 2007 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)