Skip to content
SPC Logo

Bicalutamide 150mg Film-coated Tablets

Last Updated on eMC 25-Aug-2015 View document  | Zentiva 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 25-Aug-2015 and displayed until Current

Reasons for adding or updating:

  • 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 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updat eof SMPc pil in accordance wiht Prac reccomedation onAT interval prolongation due to long term use

Updated on 27-Aug-2013 and displayed until 25-Aug-2015

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 23-Jul-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

This is an updated SPC following licence renewal.  The only change is Revision of Text date

Updated on 23-Jan-2012 and displayed until 27-Aug-2013

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 09-Sep-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - change name of MAH in UK.  Addition of alternative trading style to our MA in the UK only.  the legal entites remail the same

Updated on 14-Jan-2011 and displayed until 23-Jan-2012

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 22-Nov-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated SPC in line with innovator SPC.

Change to section 6.3- shelf life has been increased from 3 years to 5 years

Updated on 18-Sep-2009 and displayed until 14-Jan-2011

Reasons for adding or updating:

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

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Zentiva

Company image
Address

One Onslow Street, Guildford, Surrey, GU1 4YS

Fax

+44 (0) 1483 554831

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

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

bicalutamide

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue