THORENS 25 000 I.U. /2.5 ml oral solution * Pharmacy Only: Prescription
Company:
Galen Pharma Ireland LimitedStatus:
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 January 2023
File name
63ce707a8c0ca.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 December 2020
File name
05-2_1606826151.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2020
File name
05-2_1600260707.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 16 September 2020
File name
05-3_1600257963.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 16 September 2020
File name
05-3_1600257963.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 06 June 2019
File name
Thorens 25000_1559808973.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal/change of distributor
Updated on 09 October 2018
File name
ie-spc-thorens-25000_1539072530.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 9 of the THORENS 25 000 I.U. /2.5ml oral solution Summary of Product Characteristics has been updated to add in the date of last renewal.
Updated on 01 August 2018
File name
Thorens 25000 PIL_1533132200.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 01 August 2018
File name
thorens 25000 compressed_1533129723.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 9 - Date of first authorisation/renewal of the 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
.
Updated on 01 August 2018
File name
thorens 25000 compressed_1533128529.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 9 - Date of first authorisation/renewal of the 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
.
Updated on 29 June 2015
File name
PIL_16387_515.pdf
Reasons for updating
- New PIL for new product
Updated on 29 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)