Osteofos D3 * Pharmacy Only: Prescription
Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 May 2021
File name
ie-spc Osteofos D3 clean Approved April 21_1621792294.pdf
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 6.1 - List of excipients
- 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
Section 2 - Excipient content of propylene glycol (E 1520) added
Section 4.4 - Sucrose and propylene glycol excipient content warnings added
Section 6.1 - Enumber for propylene glycol added (E 1520)
Section 10 - Date of revision updated
Updated on 23 May 2021
File name
ie-leaflet Osteofos D3 clean Dec 2020 Approved April 21_1621792053.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - Excipient warnings for sodium and propylene glycol (E 1520) added
Section 6 - E number for propylene glycol added - (E1520)
Change to other sources of information - removed product names for other markets.
Updated on 04 May 2017
File name
PIL_7920_396.pdf
Reasons for updating
- New PIL for new product
Updated on 04 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 May 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 6.6 - 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 May 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 29 June 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Section 1 Name of the medicinal product: amend the product name to add the product strength - Osteofos D3 1200 mg/ 800 I.U. powder for oral suspension
- Section 2 Qualitative and quantitative composition: add information on the excipient Sunset yellow FCF (E110) and sucrose
- Section 4.8 Undesirable effects: information reformatted according to the MedRA Systme Organ Class.
- Section 4.9 Overdose: Additional information added on overdose leading to hypervitaminosis and hypercalcaemia, symptoms of hypercalcaemia and treatment. Information on vitamin D intoxication.
- Section 6.6 Special precautions for disposal: new sentence added - The appearance of the reconstituted product is a smooth orange opaque suspension with visible white granules.
- Section 9 Date of the Renewal of the Authorisation updated to 23 September 2009
- Section 10 Date of revision of the text: Update to May 2010
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The main changes to the SmPC are as follows:
- Section 1 Name of the medicinal product: amend the product name to add the product strength - Osteofos D3 1200 mg/ 800 I.U. powder for oral suspension
- Section 2 Qualitative and quantitative composition: add information on the excipient Sunset yellow FCF (E110) and sucrose
- Section 4.8 Undesirable effects: information reformatted according to the MedRA Systme Organ Class.
- Section 4.9 Overdose: Additional information added on overdose leading to hypervitaminosis and hypercalcaemia, symptoms of hypercalcaemia and treatment. Information on vitamin D intoxication.
- Section 6.6 Special precautions for disposal: new sentence added - The appearance of the reconstituted product is a smooth orange opaque suspension with visible white granules.
- Section 9 Date of the Renewal of the Authorisation updated to 23 September 2009
- Section 10 Date of revision of the text: Update to May 2010
Updated on 22 June 2010
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 24 February 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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 24 February 2009
Reasons for updating
- Change due to user-testing of patient information
- Introduction of new pack/pack size
Updated on 15 September 2005
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 September 2005
Reasons for updating
- Change of contraindications
Updated on 10 August 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2004
Reasons for updating
- New PIL for new product