Summary of Product Characteristics
last updated on the eMC:
07/07/2010
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 07/07/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
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 4.2 - 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 4.5 - Interaction with other medicinal products and other forms of interaction
-
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
-
Change to section 4.9 - Overdose
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6.2 - Incompatibilities
-
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
|
| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Update of section 1, 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.2, 6.3, 6.4 & 6.5
Implementation of Article 30 referral procedure to harmonise all cetirizine hydrochloride SmPCs in EU and also according to the current SmPC guidelines.
|
|
Updated on 08/02/2006 and displayed until 07/07/2010
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 6. 5 - Nature and Contents of Container
|
|
Updated on 08/02/2006 and displayed until 08/02/2006
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 9 - Date of Renewal of Authorisation
|
|
Updated on 16/04/2003 and displayed until 08/02/2006
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 17/01/2003 and displayed until 16/04/2003
|
Reasons for adding or updating:
|
-
Change to separate SPCs covering individual presentations
|
|