Diovan 3mg/ml Oral Solution *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 05 January 2021

File name

Diovan OS_REG SPC_PF 20-0095_December 2020_IPHA_1609850844.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_1609850535.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_1583248675.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_1574181621.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_1573647256.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_1543927122.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 4.5 - spelling mistake was corrected.
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

Changes were made throughout the SmPC in line with that recommended by the PRAC committee, resulting from the Article 31 Referral on the combined use of Renin-angiotensin-system (RAS)-acting agents in patients with hypertension and heart failure.
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 4.2 regarding a clarification in the maximum dose given per body weight in children.
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

Section 2:
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

Change to date of revision of text

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)

Free text change information supplied by the pharmaceutical company

None provided