Drovelis 3 mg/14.2 mg film-coated tablets
*Company:
Gedeon Richter IrelandStatus:
UpdatedLegal 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 20 March 2026
File name
Drovelis PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Update to the text following MA renewal.
Updated on 20 March 2026
File name
Drovelis SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of the text during MA renewal.
Updated on 05 March 2025
File name
Drovelis PIL.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
- Change to warnings or special precautions for use
Updated on 05 March 2025
File name
Drovelis SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 4.2 - Updated information with reference to patients with renal impairment and the paediatric population.
Section 4.8 - New subheading to include additional information with reference to the paediatric population.
Section 5.1 - Updated information under the subheading Paediatric Population.
Section 5.2 - Average peak plasma concentration after intake of Drovelis updated from 17.9 to 18 ng/mL 0.5-2 hours after single ingestion.
Updated information under the subheading Renal Impairment
Updated information under the subheading Paediatric Population.
Section 10 - Updated to 30/1/2025
Updated on 17 July 2024
File name
Drovelis SmPC Jul 2024.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.2 and 5.2 - Updated to include additional information under the subheading Hepatic Impairment.
Updated on 11 January 2024
File name
Drovelis_UK_IE_MT__PIL_completed.pdf
Reasons for updating
- Change to date of revision
File name
pcard_DROVELIS_UK-IE-MT_K31053-12_29430790.pdf
Reasons for updating
- Add New Doc
File name
CHC prescriber-checklist - IE Gedeon Richter FINAL.pdf
Reasons for updating
- Add New Doc
Updated on 05 July 2023
File name
Drovelis 3 mg-14,2 mg fctbl_PIL_en_EU-1-21-1547-001-004.pdf
Reasons for updating
- New PIL for new product
Updated on 05 July 2023
File name
Drovelis 3 mg-14,2 mg fctbl_SmPC_en_EU-1-21-1547-001-004.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Gedeon Richter Ireland
 Ltd.webp)
Address:
4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@gedeonrichter.euTelephone:
00 44 207 604 8800Medical Information Direct Line:
00 44 207 604 8806