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BUFYL 1mg/ml and 2microgram/ml Solution for Infusion

Last Updated on eMC 07-Apr-2017 View document  | Concordia International - formerly AMCo 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.

Updated on 07-Apr-2017 and displayed until Current

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 4.3 - Contraindications
  • Change to section 4.6 - Fertility, 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 31-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2, 4.1, 4.2, 4.3, 4.6, 4.7, 4.8, 5.1, 5.2, 6.5 and 6.6 has been updated

Updated on 29-Oct-2014 and displayed until 07-Apr-2017

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 4.7 - Effects on ability to drive and use machines

Date of revision of text on the SPC: 24-Oct-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.7: Update to Effects on Ability to Drive and Use Machines

Updated on 14-May-2014 and displayed until 29-Oct-2014

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 30-Apr-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1: Addition of generic name

Consequently sections 4.1 to 4.3 have been updated to reflect this change.

Section 4.8: Addition of information on how to report side effects.

Updated on 27-Nov-2012 and displayed until 14-May-2014

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 30-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7: Change in MAH details from antigen to Mercury Pharma

Updated on 14-Feb-2012 and displayed until 27-Nov-2012

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Concordia International - formerly AMCo

Company image
Address

Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK

Fax

+44 (0)208 588 9200

Medical Information e-mail
Medical Information Fax

+44 (0)20 8588 9200

Telephone

+44 (0)208 588 9131

Medical Information Direct Line

08700 70 30 33

Customer Care direct line

+44 (0)208 588 9273

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

bupivacaine hydrochloride, fentanyl citrate

Legal categories

POM - Prescription Only Medicine

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