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Ravicti 1.1 g/ml oral liquid

  • Name:

    Ravicti 1.1 g/ml oral liquid

  • Company:
    info
  • Active Ingredients:

    Glycerol phenylbutyrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/20

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Immedica Pharma AB

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Company Products

Medicine NameActive Ingredients
Medicine Name Ammonaps 500 mg tablets Active Ingredients Sodium Phenylbutyrate
Medicine Name Ravicti 1.1 g/ml oral liquid Active Ingredients Glycerol phenylbutyrate
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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 3 September 2020 PIL

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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 3 September 2020 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC updated followijng renewal application

Updated SPC sections are shown below

 

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

4.2       Posology and method of administration

4.4       Special warnings and precautions for use

4.6       Fertility, pregnancy and lactation

4.7       Effects on ability to drive and use machines

4.8       Undesirable effects

5.1       Pharmacodynamic properties

5.2       Pharmacokinetic properties

5.3       Preclinical safety data

6.5       Nature and contents of container

6.6       Special precautions for disposal and other handling

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10.     DATE OF REVISION OF THE TEXT

25/06/2020

Updated on 7 January 2020 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 January 2020 PIL

Reasons for updating

  • New PIL for new product