Protium 20mg
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 June 2023
File name
ie-pl-20mg-clean-ccds-9-approved-06-06-2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
Updated on 15 June 2023
File name
ie-spc-20mg-clean-ccds-9-approved-06-06-2023.pdf
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 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The following major changes have been made. Other changes are administrative/formatting changes.
In section 4.4 Special warnings and precautions for use, the following text has been added:
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs) including erythema multiforme, Stevens‑Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) which can be life‑threatening or fatal, have been reported in association with pantoprazole with frequency not known (see section 4.8).
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
If signs and symptoms suggestive of these reactions appear, pantoprazole should be withdrawn immediately and an alternative treatment considered.
In section 4.5, Interaction with other medicinal products and other forms of interaction, the following text has been added:
Drug-laboratory test interactions
There have been reports of false-positive results in some urine screening tests for tetrahydrocannabinol (THC) in patients receiving pantoprazole. An alternative confirmatory method should be considered to verify positive results.
Updated on 27 May 2022
File name
ie-pl-20mg-clean-ccds-8.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 27 May 2022
File name
ie-spc-20mg-18-05-2022.pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 of the SmPC “Interstitial nephritis” has been updated to “Tubulointerstitial nephritis” (TIN)
Updated on 11 June 2021
File name
m1-3-1-SPC-20mg-IRE-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following main changes have been made to the SmPC (other changes to headers and minor text changes have been made):
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Section |
Change |
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4.2 Posology and method of administration |
Added: Title: Special populations Elderly No dose adjustment is necessary in the elderly (see section 5.2). |
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4.4 Special warnings and precautions for use |
Added: Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. Hypomagnesaemia may lead to hypocalcaemia and/or hypokalaemia (see section 4.8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI. Protium contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium‑free’. |
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4.8 Undesirable effects |
Added Drug reaction with eosinophilia and systemic symptoms (DRESS) |
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6.5 Nature and contents of container |
Added: 50 (50x1) gastro-resistant tablets *Please note these new pack sizes will not currently be marketed in Ireland. |
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10 Date of revision of the text |
28/05/2021 |
Updated on 11 June 2021
File name
m1-3-1-leaflet-20mg-IRE-.clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 27 May 2021
File name
m1-3-1-SPC-20mg-IRE-28.04.2020.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The MAH address has changed:
From: First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
To: 6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland
Date of revision: 28.04.20
Updated on 27 May 2021
File name
m1-3-1-leaflet-20mg-IRE-28.04.2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 August 2019
File name
Protium PIL 20mg IRE 31.07.19.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 August 2019
File name
Protium SmPC 20mg IRE 31.07.2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 (undesirable effects) addition of Microscopic colitis.
Section 5.3 (Preclinical safety data) addition of the following:
In a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure. By the end of the recovery phase, bone parameters were similar across groups and body weights were also trending toward reversibility after a drug-free recovery period. The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old. The relevance of this finding to the paediatric population is unclear. A previous peri-postnatal study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 5 mg/kg in this study.
Date of revision: 31st July 2019
Updated on 29 March 2019
File name
m1-3-1-SPC-20mg-IRE-17.01.2019.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SmPCs for Protium in Ireland have been updated following a worksharing procedure to update section 5.3.
Updated on 16 November 2018
File name
m1-3-1-SPC-20mg-IRE-proposed clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- In section 6.5, Nature and contents of container, the 168 tablet bottle has been deleted
- In section 10, Date of revision has been updated to 26th October 2018
Updated on 19 February 2018
File name
PIL_12332_379.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 February 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Change to section |
Details of change |
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7. MARKETING AUTHORISATION HOLDER |
Takeda Products Ireland Ltd. First Floor, 3013 Lake Drive, Citywest Business Campus, |
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8. MARKETING AUTHORISATION NUMBER(S) |
PA 2229/010/001 |
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10. DATE OF REVISION OF THE TEXT |
02/02/2018 |
Updated on 19 February 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 10 April 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 April 2017
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 November 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with {Tradename} may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
Section 4.4 following text added:
Interference with Laboratory Tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Protium treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Section 5.1 following text added:
During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
Updated on 28 October 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 06 October 2016
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Takeda UK Limited
Building 3,
Glory Park,
Glory Park Avenue,
Wooburn Green,
Bucks,
HP10 0DF
UK
MA number updated to: PA 1547/009/002
Date of revision updated to: 30Sep2016
Updated on 30 September 2016
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 15 January 2016
Reasons for updating
- 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 - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration
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Addition of heading:
Oral use The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.
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4.4 Special warnings and precautions for use
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The following section previously entitled ‘In presence of alarm symptoms’ has been updated to:
Gastric malignancy Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
Gastric malignancy Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
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4.4 Special warnings and precautions for use
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The following section previously entitled ‘Co-administration with atazanavir’ had been updated to:
Co-administration with HIV protease inhibitors Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).
Co-administration with HIV protease inhibitors Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).
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4.4 Special warnings and precautions for use
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The following section has been updated to:
Gastrointestinal infections caused by bacteria Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.
Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.
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4.4 Special warnings and precautions for use
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The following new section has been added:
Sub-acute cutaneous lupus erythematosus (SCLE) Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping Protium. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
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4.5 Interaction with other medicinal products and other forms of interaction
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The following section has been updated, including updated subheadings as follows:
Medicinal products with pH-Dependent Absorption Pharmacokinetics Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other medicinal products where gastric pH is an important determinant of oral availability, e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicines such as erlotinib.
HIV protease inhibitors) Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).
If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted
Coumarin anticoagulants (phenprocoumon or warfarin) Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time.
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4.5 Interaction with other medicinal products and other forms of interaction
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The following sentence has been added:
An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.
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4.5 Interaction with other medicinal products and other forms of interaction
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The following section has been added:
Medicinal products that inhibit or induce CYP2C19:
Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of pantoprazole, or those with hepatic impairment.
Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.
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4.6 Fertility, pregnancy and lactation |
The following sections have been updated:
Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Protium. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Protium during pregnancy.
Breast-feeding Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from Protium therapy should take into account the benefit of breast-feeding for the child, and the benefit of Protium therapy for the woman.
Fertility There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
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4.7. Effects on ability to drive and use machines |
The following information has been added:
Pantoprazole has no or negligible influence on the ability to drive and use machines.
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4.8. Undesirable effects |
The following adverse reaction has been added to Table 1 under skin and subcutaneous tissue disorders:
Sub-acute cutaneous lupus erythematosus (see section 4.4) |
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10. Date of revision of the text |
Updated to:
23/12/2015 |
Updated on 15 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
Updated on 30 October 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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CHANGE TO SECTION |
DETAILS OF CHANGE |
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION |
Moved: Paediatric population Protium is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in the age group (see section 5.2).
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4.8. UNDESIRABLE EFFECTS
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Added: 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
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10. DATE OF REVISION OF THE TEXT |
Changed to: 13th October 2014 |
Updated on 30 October 2014
Reasons for updating
- Change to date of revision
Updated on 12 April 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.3 Shelf life
Inclusion of: Shelf life for HDPE bottles after first opening: 120 days.
10. DATE OF REVISION OF THE TEXT
To: 02/01/2013
Updated on 12 April 2013
Reasons for updating
- Change to storage instructions
Updated on 18 December 2012
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Takeda GmbH
In section 10 Date of revision of the text is 30/11/2012
Updated on 18 December 2012
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 03 October 2012
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC update to include Bone Fracture and Hypomagnesaemia Safety Warnings in Section 4.4 and 4.8
Updated on 27 September 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 02 March 2012
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 February 2012
Reasons for updating
- Change to side-effects
Updated on 18 April 2011
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 April 2011
Reasons for updating
- Change of inactive ingredient
Updated on 06 September 2010
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change in the Summary of Product Characteristics following a procedure in accordance with Article 30 of Directive 2001/83/EC (referral procedure) to harmonise the product information for all pantoprazole products in the range.
Updated on 27 August 2010
Reasons for updating
- Improved electronic presentation
Updated on 12 March 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 8: Update to PA number
Section 10: Updated to reflect approval of above changes
Updated on 12 March 2008
Reasons for updating
- Change to marketing authorisation holder
- Change to date of revision
Updated on 01 February 2008
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
- Changes to therapeutic indications
Updated on 04 January 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 August 2007
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 - The addition of the co-administration of pantoprazole with atazanavir as a contraindication
Section 4.5 - The addition of a possible interaction with the co-administration of pantoprazole with atazanavir
Section 4.8 - The addition of depression, hallucination, disorientation and confusion as rare side effects
Updated on 22 August 2007
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2006
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 July 2006
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
| Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.8 - Undesirable Effects, Change to section 10 (date of (partial) revision of the text | |
| Change details: |
4.5 Interactions with other Medicaments and other forms of Interaction
The following statement has been added: The response to anticoagulants such as warfarin, phenprocoumon or acenocoumarol may be affected by any concomitant medication
4.8 Undesirable Effects
The following have been added to this section: Leukopenia: Thrombocytopenia, Dry mouth, Arthralgia, Vomiting
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Updated on 10 August 2005
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)