Diovan 3mg/ml Oral Solution
*Company:
Novartis 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 08 May 2023
File name
Diovan-oral-solution PF23-0062-REGPIL May 2023 clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 08 May 2023
File name
Diovan OS REGSPC PF23-0062 May 2023 Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2022
File name
Diovan OS_REG SPC_PF 22-0044_May 2022_IPHA.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2022
File name
Diovan OS_REG PIL_PF 22-0044_May 2022_Clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 01 October 2021
File name
Diovan OS_REG PIL_PF 21-0133_September 2021_Clean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 05 January 2021
File name
Diovan OS_REG SPC_PF 20-0095_December 2020_IPHA.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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 January 2021
File name
Diovan OS_REG PIL_PF 20-0095_December 2020_Clean.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 03 March 2020
File name
Diovan OS REG PIL PF 19-0270_IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 19 November 2019
File name
Diovan oral solution_REG PIL_PF 18-0157_IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 13 November 2019
File name
Diovan oral solution_REG SPC_PF 18-0157_IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 December 2018
File name
Diovan 3mg_ml Oral Solution REG PIL_1771714_R91_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 July 2018
File name
DiovanOralSolutionSPC_REG_PF 18-0185_clean.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 11 May 2018
File name
DiovanOralSolution.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 24 January 2017
File name
PIL_14853_836.pdf
Reasons for updating
- New PIL for new product
Updated on 24 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
Updated on 22 April 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 April 2016
Reasons for updating
- Correction of spelling/typing errors
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - adverse reactions updated to adverse drug reactions
Throughout font style was made uniform.
Updated on 14 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to improve clarity and readability
Updated on 25 August 2015
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
A tracked changes version of the SmPC can be provided if necessary.
Updated on 14 August 2014
Reasons for updating
- Change to side-effects
- Change to dosage and administration
- Change to product name
- Addition of information on reporting a side effect.
Updated on 13 May 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
updated section 4.5 of the SmPC with information regarding an interaction between valsartan and lithium.
updated section 4.8 of the SmPC with new adverse drug reaction (i.e. dermatitis bullous has been included).
Updated on 09 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
Updated on 21 November 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Reduced content of methyl parahydroxybenzoate from 1.62mg to 1.22mg, as it is a preservative and the final drug product is intended as a paediatric formulation.
Updated on 04 November 2013
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2, added:
Renal impairment.....
“Concomitant use of Diovan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min/1.73 m2) (see section 4.3).
Diabetes Mellitus
Concomitant use of Diovan with aliskiren is contraindicated in patients with diabetes mellitus (see section 4.3).”
Section 4.3, added:
“-Concomitant use of angiotensin receptor antagonists (ARBs) - including Diovan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.4 and 4.5).”
Section 4.4 added:
Impaired renal function:
....... “The concomitant use of ARBs - including Diovan - or of ACEIs with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.3 and 4.5).
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS)
Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.
The use of aliskiren in combination with Diovan is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).”
Section 4.5, added:
“Dual blockade of the Renin-Angiotensin- System (RAS) with ARBs, ACEIs, or aliskiren
Caution is required while co-administering ARBs, including Diovan, with other agents blocking the RAAS such as ACEIs or aliskiren (see section 4.4).
Concomitant use of angiotensin receptor antagonists (ARBs) - including Diovan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) is contraindicated (see section 4.3).”
Updated on 24 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
Updated on 15 March 2013
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 19 November 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration
Posology, Children and adolescents 6 to 18 years of age has been updated
In Section 4.4 Special warnings and precautions for use, information has been added on History of angioedema
In Section 4.5 Interaction with other medicinal products and other forms of interaction information on Transporters has been added.
Updated on 16 May 2011
Reasons for updating
- Change to name of manufacturer
Updated on 15 December 2010
Reasons for updating
- New PIL for new product
Updated on 09 June 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)