Solaraze 3% Gel
*Company:
Almirall 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 12 June 2024
File name
ie-spc-5854- Solaraze-May 2024.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.4 - Special warnings and precautions for use
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.4 - Addition of excipient warning for benzyl alcohol: This medicinal product contains 10 mg benzul alcohol ineach g. Benzyl alcohol may cause allergic reactions and mild local irritation.
All other sections - editorial changes in line with current QRD template.
Updated on 12 June 2024
File name
ie-uk-pl-solaraze-Apr 2024.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 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - excipient warning for benzyl alcohol added
All other sections are editorial changes in line with current QRD template.
Updated on 12 January 2021
File name
ie-spc-solaraze-Jan19.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1 - removal of (TM)
Section 2 - addition of benzyl alcohol (excipient of known effect)
Section 4.4 - addition of allergy warning for benzyl alcohol
Updated on 20 January 2020
File name
uk-ie-pl-solaraze-jan2018-approved.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
3) How to use Solaraze - addition of:
Gently smooth a small amount of gel onto the skin over the area to be treated. The amount of gel
needed will vary depending upon the size of the area to be treated. Usually 0.5 grams of gel
(about the size of a pea) will be enough for one area (5cm x 5cm) but not more than 8 grams
should be used per day.
Updated on 20 January 2020
File name
ie-spc-solaraze-Jan19.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration
Addition of
Maximum daily amount of 8 g of product allows simultaneous treatment of up to 200 cm2 skin surface.
(Removal of: Long term efficacy has not been established.)
Updated on 27 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 March 2018
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 4.4 - Special warnings and precautions for use
- 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
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1- Indication corrected to: actinic keratosis (AK)
Section 4.2 - Removal of long term efficacy has not been established plus editiorial and QRD updates.
Section 4.4 - addition of full wording for NSAIDs - nosteroidal anti-inflammatory drugs
Section 4.6 - QRD template updates
Section 4.8 - Improved QRD template ordering of side-effects.
Section 5.1 - Inclusion of a summary of clinical efficacy and safety data from clinical trials.
Section 5.2 - Correction of two minor typographical errors.
Section 6.6 - QRD template updates
Section 8 - QRD template updates
Section 10 - date of revision February 2018
Updated on 26 March 2018
File name
PIL_14294_166.pdf
Reasons for updating
- New PIL for new product
Updated on 26 March 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 26 November 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 4.8
Addition of QRD template ADR reporting statement
Section 10 - Date of revision of text
August 2015
Updated on 24 November 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 07 February 2012
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.3 - clarified trimester of pregnancy
4.4 - additional precautions added
4.5 - information reworded
4.6 - information reworded
4.7 - information expanded
4.8 - additional undesirable effects added and frequencies changed
4.9 - additional overdose information added
Updated on 03 February 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
Updated on 23 March 2010
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
- 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 6.3: the following sentence added " after 1st opening: 6 months"
Section 7: Name change of MAH from Laboratorios Almirall to "Almirall, S.A."
Section 10: to reflect latest date of revision/approval of SmPC
Updated on 17 March 2010
Reasons for updating
- Change of licence holder
- Change to storage instructions
Updated on 04 June 2009
Reasons for updating
- Addition of separate SPCs covering individual presentations
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 June 2009
Reasons for updating
- New PIL for medicines.ie