Last Updated on eMC 12-01-2018 View medicine  | Actavis UK Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:16-09-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Budesonide 0.5mg, 1mg Nebuliser Suspension, PL 18023/0007-8 (DK/H/0703/001-003/IB&IA/056,059,060)

MA holder: Breath Limited

 

 

SmPC sections updated: 2, 4.4, 4.5, 4.6, 4.8 and 10

PIL sections updated: 2, 4 and 6

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:16-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Budesonide 0.5, 1mg Nebuliser Suspension, PL 18023/0007, 0008

DK/H/0703/001-003/IB/056

 

Variation approval date – 16.09.16

Approval received – 19.09.2016

 

Single variation –

Variation type – IB, C.I.3.z

 

Variation description – Update to product information in line with recommended changes to the product information and Final Assessment Report from the EU PSUR Worksharing procedure (DK/H/PSUR/0041/002) for budesonide nasal spray, nebuliser suspension, oral forms, rectal forms, nasal powder, inhalation powder on 07/04/2016.

 

SmPC sections updated – 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 6.1, 6.5 and 10

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:07-01-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SmPC section(s) updated 7 and 10

Change of the address of the MA holder in UK: Breath Limited from Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom to Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Fertility, pregnancy and lactation
  • 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

Date of revision of text on the SPC:11-03-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC sections updated – 4.1, 4.2, 4.3, 4.4, 4.6, 4.8, 5.1, 5.2 and 10

 

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO