Xagrid 0.5mg hard capsule
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 February 2023
File name
IE-xagrid-spc-clean-MAH-Manu Jan2023.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
There has been a MAH and batch release site address change.
Updated on 03 February 2023
File name
IE-NI-xagrid-pil-clean-MAH-Manu Jan2023.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
MAH and batch release site address change.
Updated on 08 April 2022
File name
IE-NI-xagrid-pil-clean-Feb2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
A corrected version of the PIL has been uploaded to combine the updates made on 15 February 2022 and 04 March 2022.
Updated on 04 March 2022
File name
IE-NI-xagrid-pil-clean-MIA-Feb22.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
In section 6, the manufacturer has been updated to be the same as the MAH.
Updated on 15 February 2022
File name
IE-NI-xagrid-pil-clean-Feb2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 February 2022
File name
IE-xagrid-spc-clean-Feb2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Section |
Change |
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4.4 Special warnings and precautions for use |
Added: Thrombotic Risk Abrupt treatment discontinuation should be avoided due to the risk of sudden increase in platelet counts, which may lead to potentially fatal thrombotic complications, such as cerebral infarction. Patients should be advised how to recognize early signs and symptoms suggestive of thrombotic complications, such as cerebral infarction, and if symptoms occur to seek medical assistance.
Treatment discontinuation In the event of dosage interruption or treatment withdrawal, the rebound in platelet count is variable, but the platelet count will increase within 4 days of stopping treatment with anagrelide and will return to pre-treatment levels within 10 to 14 days, possibly rebounding above baseline values. Therefore, platelets should be monitored frequently. (see section 4.2)
Deleted:
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4.8 Undesirable effects |
Added under Nervous system disorders Cerebral infarction (see section 4.4) |
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10 Date of revision of the text |
01 February 2022 |
Updated on 17 December 2021
File name
IE-NI-xagrid-pil-clean-MAT-dec2021.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The following changes have been made: Marketing Authorisation transfer from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals Integration Ireland Branch.
Date of revision: 12/2021
Updated on 17 December 2021
File name
IE-xagrid-spc-clean-MAT-dec2021.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following changes have been made: In section 7, Marketing Authorisation transfer from Shire Pharmaceuticals Ireland Limited to Takeda Pharmaceuticals Integration Ireland Branch.
Date of Revision: 03 December 2021
Updated on 26 November 2020
File name
ie-xagrid-spc-clean-TII-89-6Nov2020.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following changes have been made to the SmPC:
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Section |
Change |
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4.5 Interaction with other medicinal products and other forms of interaction |
Updated: CYP1A2 inducers
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4.8. Undesirable effects Reporting of suspected adverse reactions |
Updated: Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. |
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5.2 Pharmacokinetic properties |
Added: Biotransformation Anagrelide is primarily metabolised by CYP1A2 to form, 3-hydroxy anagrelide, which is further metabolised via CYP1A2 to the inactive metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline. The effect of omeprazole, a CYP1A2 inducer, on the pharmacokinetics of anagrelide was investigated in 20 healthy adult subjects following multiple, once daily 40‑mg doses. The results showed that in the presence of omeprazole, AUC(0-∞), AUC(0-t), and Cmax of anagrelide were reduced by 27%, 26%, and 36%, respectively; and the corresponding values for 3‑hydroxy anagrelide, a metabolite of anagrelide, were reduced by 13%, 14%, and 18%, respectively. |
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10 Date of revision of the text |
06 November 2020 |
Updated on 05 March 2020
File name
uk-ie-pl-clean-TII-0086-Sept 2019.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The correct version of the PIL was not loaded previously, so the correct version has been uploaded.
Updated on 28 February 2020
File name
uk-ie-mt-pl-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 February 2020
File name
uk-ie-spc-clean-TII-0086-Jan 2020.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (Undesirable effects), prinzmetal angina has been added under cardiac disorders as a rare adverse reaction.
Date of the revision of the text: 30 January 2020
Plus editorial uplates.
Updated on 06 September 2019
File name
uk-ie-mt-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 September 2019
File name
uk-ie-mt-spc-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 9, update to the renewal date.
Updated on 05 November 2018
File name
PIL - MC.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to other sources of information section
- Company name change or merger
Updated on 31 October 2018
File name
PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to other sources of information section
- Company name change or merger
Updated on 31 October 2018
File name
SmPC.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Company name change or merger
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 7 (Marketing authorisation holder), MAH name and address change to 'Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland'
Updated on 22 May 2018
File name
UK_IE-Xagrid-SmPC-04_18-Clean.docx
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018
File name
UK_IE-Xagrid-SmPC-04_18-Clean.docx
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2018
File name
UK_IE-PIL-05_18-Clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 05 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 September 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 August 2017
File name
PIL_10765_135.pdf
Reasons for updating
- New PIL for new product
Updated on 17 August 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 July 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 (undesirable effects) - re-classification of ‘Pulmonary Hypertension’ from “rare” to “uncommon”
Updated on 10 July 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 17 May 2017
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4:
Platelets
The platelet count will increase within 4 days of stopping treatment with anagrelide and will return to pre-treatment levels within 10 to 14 days, possibly rebounding above baseline values. Therefore platelets should be monitored frequently..
Section 4.5
Effects of other active substances on anagrelide
· In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
CYP1A2 inhibitors
· Anagrelide is primarily metabolised by CYP1A2. It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and enoxacin, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
· In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
CYP1A2 inducers
· CYP1A2 inducers (such as omeprazole) could decrease the exposure of anagrelide increasing its main active metabolite. The consequences on the safety and efficacy profile of anagrelide are not established. Therefore, clinical and biological monitoring is recommended in patients taking concomitant CYP1A2 inducers. If needed, anagrelide dose adjustment could be made.
Section 5.1
Mechanism of action
The precisespecific mechanism of action by which anagrelide reduces blood platelet count is not yet fully understood although it has been confirmed that anagrelide is platelet selective from in vitro and in vivo study informationunknown. In cell culture studies, anagrelide suppressed expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.
and a corresponding update to Section 10
Updated on 15 May 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 07 December 2015
Reasons for updating
- Change to date of revision
Updated on 07 May 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of section 4.6 of the SmPC with new information regarding breast-feeding and fertility.
Update of section 5.3 of the SmPC based on new non-clinical data.
Update of section 10. Date of revision of the text to April 2015.
In addition, Shire took the opportunity to make editorial changes in the SmPC and to update the contact details of the local representatives in the Package Leaflet.
Updated on 01 May 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 24 November 2014
Reasons for updating
- Change to paediatric information
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections have been updated to include new information on use in the paediatric population in line with the completed Paediatric Investigation Plan (PIP). See the relevant ‘Paediatric population’ sub-section under -
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.8 Undesirable effects
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
Other
4.4 Special warnings and precautions for use – update regarding monitoring for evidence of cardiovascular effects.
Minor text updates in line with the latest version of the Quality Review Document (QRD) template throughout the SmPC.
Updated on 24 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
Updated on 31 July 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Use of concomitant anagrelide and acetylsalicylic acid has been associated with major haemorrhagic events (see section 4.5).
Section 5.2 has been updated with the appropriate QRD sub-headings.
Updated on 04 February 2014
Reasons for updating
- Change of manufacturer
Updated on 04 December 2013
Reasons for updating
- Addition of black triangle
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In line with QRD9 addition of Black Triangle and associated text.
In section 4.2 (Posology and method of administration) and 5.2 (Pharmacokinetic properties), QRD9 template update to wording re the elderly.
In section 4.4 (Special warnings and precautions for use), updates to Monitoring and Cardiovascular subsections following the results of a thorough QT/QTc study.
In section 4.5 (Interactions), reference to omeprozole replaced with enoxacin.
In section 4.8 (Undesirable effects) addition of torsade de pointes, in line with updates in section 4.4. QRD9 updates regarding reporting of suspected adverse events.
In Section 5.1 (Pharmacodynamic properties), new section added as result of the QT/QTc study.
Updated on 02 December 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
- Addition of black triangle
Updated on 04 June 2013
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 03 June 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
QRD 8.2 amendments as follows:
In section 2, Excipients header changed to Excipient(s) with known effect.
In section 4.3 crossreference to section 6.1 added
In section 5.1, 'm' added to SmPC
In section 9 - reference to month changed from numbers to letters ie November
In section 10 - revision date amended.
Updated on 23 January 2013
Reasons for updating
- 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 4.5 - 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
-
Changes to SmPC:
-
QRD version 8 template changes.
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Section 4.2 (Posology and method of administration), Paediatric population, Renal and Hepatic impairment sections re-worded.
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Section 4.4 (Special warnings and precautions for use, cardiovascular), updated with serious cardiac side effects added from section 4.8 Please notification form for more details.
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Section 4.5 (Interaction with other medicinal products and other forms of interaction), paediatric population added to this section.
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Section 4.6 (Fertility, pregnancy and lactation), section re-worded.
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Section 4.8 (Undesirable effects), section reformatted and two new terms added to Respiratory SOC “Pneumonitis and Interstitial Lung Disease”, these are used in addition/interchangeably to allergic alveolitis.
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Section 4.9 (Overdose), has been re-ordered.
Updated on 22 January 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
Updated on 06 June 2011
Reasons for updating
- Change to further information section
Updated on 18 May 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2011
Reasons for updating
- Change to drug interactions
Updated on 28 February 2011
Reasons for updating
- Change to MA holder contact details
- Change to name of manufacturer
- Correction of spelling/typing errors
Updated on 08 December 2010
Reasons for updating
- Change to side-effects
- Change of distributor details
- Correction of spelling/typing errors
Updated on 07 December 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable Effects: was amended to add ' Tubulointerstitial nephritis' to the subsection, 'Renal and urinary disorders'. The incidence rate is not known.
Section 10 Date of Revision of the Text: was amended to reflect the approval date of 11/10.
Updated on 27 May 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and special precautions for use
...
GeneralMonitoring
Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), and assessment of liver function (ALT and AST) and renal function (serum creatinine and urea) tests.
...
4.8 Undesirable effects
Hepatobiliary disorders
Uncommon: Hepatic enzymes increased
Not known: Hepatitis
…
10. DATE OF REVISION OF THE TEXT
04/201005/2010
Updated on 25 May 2010
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 11 May 2010
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 January 2010
Reasons for updating
- Change to date of revision
- Change of distributor details
Updated on 01 December 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- Change to section 5 - Pharmacological properties
- 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 renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 November 2009
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
- Change to MA holder contact details
- Correction of spelling/typing errors
Updated on 09 March 2009
Reasons for 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 MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2009
Reasons for updating
- Change to warnings or special precautions for use
- Addition of marketing authorisation holder
- Change to drug interactions
Updated on 10 December 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 December 2008
Reasons for updating
- Change to further information section
Updated on 01 October 2008
Reasons for updating
- Change to further information section
Updated on 20 February 2008
Reasons for updating
- Improved electronic presentation
Updated on 18 February 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 June 2007
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 02 April 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Correction of spelling/typing errors
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 November 2006
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 16 August 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 March 2006
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 25 November 2005
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 September 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2005
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 March 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)