Summary of Product Characteristics
last updated on the eMC:
29/09/2010
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 29/09/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 20-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.4: The third paragraph has been amended as follows: "Dorzolamide contains a sulphonamido group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Section 4.8: Under the sub-heading "Skin and subcutaneous tissue disorders" the following rare side effects have been added "Stevens-Johnson syndrome, toxic epidermal necrolysis"
Registered trademark statement has been updated following merger.
|
|
Updated on 04/01/2010 and displayed until 29/09/2010
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 18-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 9 (Date of First Authorisation / Renewal of the Authorisation): Renewal Date updated to 11 November 2009, following MA renewal.
|
|
Updated on 07/07/2009 and displayed until 04/01/2010
|
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 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 24-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
The changes made to the SmPC are as follows:
Section 1: Product name now in line with QRD guidance
Section 2: The statement of active substance has been made clearer
Section 4.2: Minor corrections to usage instructions.
Now states limited data in paediatric patients with administration of dorzolamide (preserved formulation) three times a day are available.
Section 4.4: Clarification that Dorzolamide contains a sulphonamido group. Paediatric information included.
Section 4.6: Includes more detailed information concerning use of product during pregnancy and lactation
Section 4.7: Now states that
no studies on the effects on the ability to drive and use machines have been performed.
Section 5.1: Pharmacotherapeutic group explained. Other minor typographical corrections. Paediatric information and data included
Section 5.3: Findings in rabbits now included
Section 6.1: Excipients listed in full.
Section 6.3: Shelf life details have been clarified
|
|
Updated on 02/05/2006 and displayed until 07/07/2009
|
Reasons for adding or updating:
|
|
|
|
