Updated on 24/09/2010 and displayed until Current
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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 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 01-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2: section on nifedipine treated patients updated in line with section 4.5 to include “other antihypertensive agents”; Renal failure section includes extended possoloy for severe renal failure and new sub-section concerning moderate renal impairment;
Section 4.3: inclusion of “hereditary/idiopathic angioneurotic oedema” and revision to the presentation of this section;
Section 4.4: New section summarising conditions that Perdix should be used with caution in, revised presentation concerning risk of anaphylaxis, conditions that Perdix is not recommended for use in, advice regarding conditions that require careful monitoring, update information concerning hypotension, impaired renal function, angioneurotic oedema, new sections on the elderly and lactose;
Section 5.2: updated to remove dosing information in this section.
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Updated on 16/07/2010 and displayed until 24/09/2010
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9 - updated to provide greater information on symptoms and tratement in cases of overdose.
Section 10 - updated to reflect approval of the above change.
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Updated on 24/06/2010 and displayed until 16/07/2010
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5 updated to include warnings relating to possible interactions with antacids, sympathomimetics, gold and anti-diabetic medications and update the sub-section that previously referred to nifedipine only to now address antihypertensive agents.
Section 10 updated to reflect approval of the above.
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Updated on 21/05/2010 and displayed until 24/06/2010
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Reasons for adding or updating:
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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 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2: inclusion of the lactose content of each tablet
Section 3: inclusion of a description of the product and an explanation of why there is a break line present on the tablet
Section 5.1: inclusion of the Pharmacotherapeutic class and ATC code
Section 6.1: updated description of some of the excipients
Section 6.2 & 6.6: updated wording to standard terminology – no change of meaning
Section 10: updated to reflect approval date of the above changes
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Updated on 06/04/2009 and displayed until 21/05/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 01-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updated sections 7, 8 & 9 to reflect change of ownership from Schwarz Pharma Ltd to UCB Pharma Ltd.
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Updated on 26/02/2009 and displayed until 06/04/2009
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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 4.3 - Contraindications
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 19-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1, product name now includes pharmaceutical form.
Section 4.3, replacement of pregnancy wording with cross-referral to sections 4.4 and 4.6, in line with PhVWP wording.
Section 4.4, warning concerning pregnancy now included, in line with PhVWP wording.
Section 4.6, whole section revised in line with PhVWP wording.
Section 10, date updated to reflect approval of variations.
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Updated on 24/02/2009 and displayed until 26/02/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 10-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 19/12/2008 and displayed until 24/02/2009
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 9 & 10 updated to reflect approval of licence renewal.
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Updated on 27/09/2006 and displayed until 19/12/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (MA Holder) - New address added: SCHWARZ PHARMA Limited, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, United Kingdom.
Section 10 (Date of revision of text) - New date added: July 2006
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Updated on 10/08/2005 and displayed until 27/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 22/07/2005 and displayed until 10/08/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/07/2005 and displayed until 22/07/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Pending awaiting re-submission
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Updated on 27/09/2002 and displayed until 22/07/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 29/07/2002 and displayed until 27/09/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 21/11/2001 and displayed until 29/07/2002
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 15/11/2001 and displayed until 21/11/2001
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Updated on 03/08/2001 and displayed until 15/11/2001
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to separate SPCs covering individual presentations
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