Summary of Product Characteristics
last updated on the eMC:
19/07/2011
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 19/07/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
-
Change to section 6.1 - List of Excipients
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.3 - Contraindications
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 06-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Name change to Sectral 100mg/200mg capsules from SECTRAL capsules 100mg/200mg
All cases of SECTRAL changed to Sectral throughout
Typos and formatting changed throughout – some wording has changed but the meaning remains the same.
4.6 – title changes from Pregnancy and lactation to Fertility, pregnancy and lactation
5.1 – following info added;
Pharmacotherapeutic group: Beta Blocker agents; Beta blocker agents, selective, ATC code: C07AB04.
6.4 - following info added;
Store below 25°C. Store in the original package in order to protect from light and moisture.
|
|
Updated on 29/03/2011 and displayed until 19/07/2011
|
Reasons for adding or updating:
|
-
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
|
| Date of revision of text on the SPC: 22-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Update sections 4.6 (Pregnancy and lactation), 4.7 (Effects on ability to drive and use machines) and 4.8 (Undesirable effects) of the SPC following the acebutolol EU PSUR.
|
|
Updated on 08/01/2009 and displayed until 29/03/2011
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
| Date of revision of text on the SPC: 01-Nov-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
Updated on 19/09/2007 and displayed until 08/01/2009
|
Reasons for adding or updating:
|
-
New individual SPC (was previously included in combined SPC)
|
| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 (Marketing Authorisation Holder): Change to MA Holder's details to:
Sanofi-aventis
One Onslow Street
Guildford
Surrey, GU1 4YS, UK
|
|
