Summary of Product Characteristics
last updated on the eMC:
06/01/2010
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 06/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| 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
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Section 9 (Date of First Authorisation / Renewal of the Authorisation): Renewal Date updated to 11 November 2009, following MA renewal
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Updated on 07/07/2009 and displayed until 06/01/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Correction of spelling/typing errors
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| 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
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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 3: Product description has been clarified.
Section 4.2: User Instructions have been extensively revised
in order to prevent over-tightening of the cap of the bottle and reinforce the proper sealing technique to the patient.
Section 4.4: Clarification that Dorzolamide contains a sulphonamido group. Other minor typographical corrections.
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.
S
ection 5.3: Findings in rabbits now included.
Section 6.1: Excipients listed in full.
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Updated on 19/06/2007 and displayed until 07/07/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/05/2007 and displayed until 19/06/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Information on Paediatric use has been added to sections 4.2, 4.4 and 5.1.
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Updated on 04/05/2006 and displayed until 25/05/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 31/07/05 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Usage instructions (step 1 - 9) added (previously described in section 6.6).
-Section 4.3: Revised text in paragraph I.
Section 4.4: Contact lens information (last paragraph) revised/clarified.
Section 4.5: A paragraph of text regarding potential interactions for topical/systemic carbonic anhydrase inhibitors has been removed
Section 4.8: Reformatted to MedDRA, body system and prevelance.
Section 5.1: ATC Code added
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Updated on 10/06/2002 and displayed until 04/05/2006
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Reasons for adding or updating:
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 04/03/2002 and displayed until 10/06/2002
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Change to section 4.8 - Undesirable Effects
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Updated on 16/08/2001 and displayed until 04/03/2002
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Transferred from eMC version 1
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Updated on 18/04/2001 and displayed until 16/08/2001
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Updated on 20/02/2001 and displayed until 18/04/2001
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Updated on 06/09/1999 and displayed until 20/02/2001
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