Navelbine 20mg and 30mg Soft Capsules *
Pharmacy Only: Prescription

  • Company:

    Pierre Fabre Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 07 September 2022

File name

6318893a05e35.pdf

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 15 February 2022

File name

Navelbine_soft capsules_PIL_IE_20m_30mg_80mg_V7_final approved_15.02.2022_1644940238.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Section 6: Change of address of MAH

Section 6: Change of address of manufacturuer

Section 6: Updated revision date

Updated on 27 January 2021

File name

Navelbine_soft capsules_PL_EN_V5.0_20201231_1611743247.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Section 6. A change in name of the manufacturer; from Pierre Fabre Médicament Production to Fareva Pau 1.

Updated on 21 May 2020

File name

Navelbine_soft capsules_PL_EN_V4.0_20190930 No header_1590073196.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Updated PIL following aType II C.I.4 worksharing variation; Harmonisation of Section 4 of the PIL of Navelbine Soft Capsules in all European Countries.

Updated on 21 May 2020

File name

Navelbine_soft capsules_PL_EN_V4.0_20190930 No header_1590068714.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Updated PIL following a Type II C.I.4 worksharing variation; Harmonisation of the Section 4 of the PIL of Navelbine Soft Capsules in all European Countries.

Updated on 21 May 2020

File name

Navelbine_soft capsules_PL_EN_V4.0_20190930 No header_1590068714.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Updated PIL following a Type II C.I.4 worksharing variation; Harmonisation of Section 4 of the SmPC of Navelbine Soft Capsules in all European Countries.

Updated on 02 October 2019

File name

Navelbine_soft capsules_PIL_IE_Sept2019 No header_1570033032.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The Marketing Authorisation (MA) has been transferred to an EU entity as a result of Brexit, see section 6.

The Product Authorisation (PA) number has been updated to reflect the new MA Holder.

Updated on 08 February 2017

File name

PIL_12679_131.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 February 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 July 2016

Reasons for updating

  • Change to date of revision

Updated on 05 February 2016

Reasons for updating

  • Change to side-effects
  • PIL retired pending re-submission

Updated on 16 January 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • 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
  • Addition of information on reporting a side effect.

Updated on 30 December 2011

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 12 August 2011

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 03 August 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 December 2009

Reasons for updating

  • Change to improve clarity and readability

Updated on 03 December 2007

Reasons for updating

  • New PIL for new product