Stieprox Shampoo 1.5% w/w

  • Name:

    Stieprox Shampoo 1.5% w/w

  • Company:
    info
  • Active Ingredients:

    Ciclopirox Olamine USP

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/09/19

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Summary of Product Characteristics last updated on medicines.ie: 16/10/2015
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Stiefel Ireland

Stiefel Ireland

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Medicine NameActive Ingredients
Medicine Name Stieprox Shampoo 1.5% w/w Active Ingredients Ciclopirox Olamine USP
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 September 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 16 October 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 October 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 October 2015 SmPC

Reasons for updating

  • 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

1. Section 6.1 – Typographical error corrected – ‘coconut diethanolamide’ replaces ‘coconut diethanolamine’

Updated on 16 October 2015 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

1. Section 6.1 – Typographical error corrected – ‘coconut diethanolamide’ replaces ‘coconut diethanolamine’

Updated on 4 August 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • 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

• Minor QRD/editorial updates to sections 2,4.3,4.6, 5.3 & 6.1 of the SPC
• Update to HPRA details in section 4.8 of the SPC

Updated on 4 August 2015 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

• Minor QRD/editorial updates to sections 2,4.3,4.6, 5.3 & 6.1 of the SPC
• Update to HPRA details in section 4.8 of the SPC

Updated on 17 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 17 July 2015 SmPC

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

Change to address of the MA Holder

Updated on 23 December 2013 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

Section 4.2 - Posology and method of administration,
Section 4.8 - Undesirable effects

 

Updated on 23 December 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Changes to:

 

 

Section 4.2 - Posology and method of administration,
Section 4.8 - Undesirable effects

 

Updated on 20 September 2012 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

The following section had slight changes to bring them in line with the QRD format:

Section 4.5 Interactions with Other Medicaments and Other Forms of Interaction, 4.7 Effects on Ability to Drive and Use Machines, 4.9 Overdose and 6.5  Nature and Contents of Container

 

Section 1. TRADE NAME OF THE MEDICINAL PRODUCT

The name has been updated from ‘Stieprox 1.5% w/w Shampoo’ to ‘Stieprox 15mg/g Shampoo’ as requested from the IMB.

 

Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

The section on an excipient with a known effect has been added to include the excipient;

dipropylene glycol.

 

Section 4.2 Posology and Method of Administration

An additional statement was added:

The shampoo should remain in contact with the scalp for a total contact time of 3-5 minutes over the two applications.

 

And the following additional information was added:

A mild shampoo can be used in between applications of Stieprox.

 

The information under the subheading Paediatric population was added to:

The safety and efficacy of Stieprox in children under 12 years of age have not been established. .

 

Section 4.6 Fertility, pregnancy and Lactation

The information in this section was expanded from:

Ciclopirox Olamine has been used topically for many years without apparent adverse consequences.  However, the safety of Stieprox in pregnant and lactating women has not been established.

 

To:

 

Fertility

Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any impairment of fertility.

 

Pregnancy

The safety of ciclopirox olamine during human pregnancy has not been established. Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any developmental toxicity.

No effects during pregnancy are anticipated since systemic exposure is low.

 

Breast-feeding

It is not known if ciclopirox olamine is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low.

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.

 

Section 4.8 Undesirable Effects

This section was updated from:

 

Ciclopirox Olamine may rarely cause skin irritation.  If irritation occurs and persists, treatment with Stieprox should be discontinued.

 

To:

 

The following convention has been used for the classification of adverse events:

 

Very common ≥1/10

Common ≥1/100 to <1/10

Uncommon ≥1/1000 to <1/100

Rare ≥1/10000 to <1/1000

Very rare <1/10000

 

Skin and subcutaneous tissue disorders

Common:         Application site irritation including, pruritus, burning sensation and application site rash*

Uncommon:     Erythema*

 

Post-marketing

 

Immune system disorders

Rare:    Application site hypersensitivity

 

Skin and subcutaneous tissue disorders

Rare:    Skin exfoliation*

            Eczema

            Alopecia*

            Hair colour changes

*Since these effects are also symptoms of the underlying disease, it is expected that these adverse reactions would manifest as worsening of symptoms.

 

 

Section 5.1 Pharmacodynamic Properties

 

The information on the Pharmacotherapeutic group was added:

other antifungals for topical dermatological use. ATC code: D01AE14.

 

The following wording in this section was rearranged, the information remains the same:

 

Current wording

 

Present wording

 

 

Ciclopirox Olamine is a broad spectrum antifungal agent which inhibits the growth of pathogenic dermatophytes, yeast and Malassezia furfur.  It has been shown in vitro to inhibit Pityrosporum ovale and Pityrosporum orbiculare, the yeast forms of Mallassezia furfur which have been implicated as the causative organisms in conditions such as dandruff and seborrhoeic dermatitis.  Ciclopirox Olamine exhibits some antibacterial activity against a variety of Gram-positive and Gram-negative bacteria. 

 

It also has anti-inflammatory activity as result of its ability to inhibit the synthesis of prostaglandins and leukotrienes.  Ciclopirox Olamine has been shown to significantly reduce arachidonic acid-induced ear-oedema test, as measured by percentage change from control inflamed ears in mice.

 

Stieprox is as effective and well tolerated as 2% ketoconazole shampoo in the treatment of severe dandruff and seborrhoeic dermatitis.

 

 

Mechanism of action

Ciclopirox olamine is a hydroxypyridone antifungal agent which is active in vitro inhibiting the growth of various fungal species including the yeast Malassezia furfur (formerly known as Pityrosporum ovale or Pityrosporum orbiculare). The latter has been implicated as a causative organism in dandruff and seborrhoeic dermatitis. Ciclopirox olamine also exhibits some anti-inflammatory activity.

 

Pharmacodynamic effects

Ciclopirox olamine 1.5% shampoo shows in vivo antifungal activity against Malassezia spp.

A clinical study has shown that ciclopirox olamine 1.5% shampoo significantly reduced the count of Malassezia furfur spp. in samples obtained from the scalp of subjects with dandruff and/or seborrhoeic dermatitis.

 

 

 

Section 5.2 Pharmacokinetic Properties

 

The following wording in this section was rearranged:

 

Current wording

 

Present wording

 

Following topical application of Ciclopirox Olamine as a 1% cream to human skin, about 1.3% of the dose is absorbed systemically.  Ciclopirox Olamine is excreted in urine with approximately 80% of an oral dose excreted as the glucuronide metabolite.  The biological half-life is approximately 1.7 hours.

 

The potential for systemic absorption of Ciclopirox Olamine from a wash-off shampoo containing 1.5% Ciclopirox Olamine is extremely low.

 

 

Absorption

The potential for clinically significant systemic absorption of ciclopirox olamine from a wash-off shampoo containing 1.5% ciclopirox olamine is expected to be low.

 

Distribution

Following oral administration of ciclopirox olamine to humans, affinity of ciclopirox olamine to serum proteins was found to be 96±2% in the concentration range of 0.01 to 11.0 µg/mL.

 

Metabolism

The metabolic patterns after oral and dermal application are similar. Glucuronidation of ciclopirox olamine appears to be the major form of its metabolism. 

 

Elimination

Following oral administration of ciclopirox olamine to humans, 96% of the administered dose is excreted within 12 hours. Ciclopirox olamine is excreted in urine with approximately 80% of an oral dose excreted as the glucuronide metabolite.

 

 

 

Section 5.3 was updated to include:

 

Carcinogenicity

A dermal carcinogenic study in mice at concentrations of 1% and 5% ciclopirox olamine formulated in polyethylene glycol 400 applied to the intact skin, twice a week, for one year, followed by a six-month non-treatment period was conducted. No tumours were observed in any of the mice at the site of application. Overall incidence of neoplasms was similar among the treated and control groups. In addition, there is no evidence that ciclopirox olamine is carcinogenic following oral or subcutaneous administration to a number of animal species.

 

Mutagenicity

Ciclopirox olamine did not cause gene mutation or chromosomal damage in several bacterial mutagen assays or in two mammalian assays. In a battery of in vitro genotoxicity assays with ciclopirox free acid, one assay was weakly positive. The weight of evidence provided by the in vitro and in vivo assessments suggest that ciclopirox does not present a genotoxic hazard to humans.

 

Reproductive Toxicology

Reproductive studies in mice, rats, rabbits and monkeys, at doses of ciclopirox olamine 10 times that of a topical human dose, have revealed no significant evidence of impaired fertility or harm to the foetus. There is evidence that ciclopirox olamine crosses the placental barrier in animals.

 

 

Updated on 20 September 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following section had slight changes to bring them in line with the QRD format:

Section 4.5 Interactions with Other Medicaments and Other Forms of Interaction, 4.7 Effects on Ability to Drive and Use Machines, 4.9 Overdose and 6.5  Nature and Contents of Container

 

Section 1. TRADE NAME OF THE MEDICINAL PRODUCT

The name has been updated from ‘Stieprox 1.5% w/w Shampoo’ to ‘Stieprox 15mg/g Shampoo’ as requested from the IMB.

 

Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

The section on an excipient with a known effect has been added to include the excipient;

dipropylene glycol.

 

Section 4.2 Posology and Method of Administration

An additional statement was added:

The shampoo should remain in contact with the scalp for a total contact time of 3-5 minutes over the two applications.

 

And the following additional information was added:

A mild shampoo can be used in between applications of Stieprox.

 

The information under the subheading Paediatric population was added to:

The safety and efficacy of Stieprox in children under 12 years of age have not been established. .

 

Section 4.6 Fertility, pregnancy and Lactation

The information in this section was expanded from:

Ciclopirox Olamine has been used topically for many years without apparent adverse consequences.  However, the safety of Stieprox in pregnant and lactating women has not been established.

 

To:

 

Fertility

Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any impairment of fertility.

 

Pregnancy

The safety of ciclopirox olamine during human pregnancy has not been established. Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any developmental toxicity.

No effects during pregnancy are anticipated since systemic exposure is low.

 

Breast-feeding

It is not known if ciclopirox olamine is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low.

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.

 

Section 4.8 Undesirable Effects

This section was updated from:

 

Ciclopirox Olamine may rarely cause skin irritation.  If irritation occurs and persists, treatment with Stieprox should be discontinued.

 

To:

 

The following convention has been used for the classification of adverse events:

 

Very common ≥1/10

Common ≥1/100 to <1/10

Uncommon ≥1/1000 to <1/100

Rare ≥1/10000 to <1/1000

Very rare <1/10000

 

Skin and subcutaneous tissue disorders

Common:         Application site irritation including, pruritus, burning sensation and application site rash*

Uncommon:     Erythema*

 

Post-marketing

 

Immune system disorders

Rare:    Application site hypersensitivity

 

Skin and subcutaneous tissue disorders

Rare:    Skin exfoliation*

            Eczema

            Alopecia*

            Hair colour changes

*Since these effects are also symptoms of the underlying disease, it is expected that these adverse reactions would manifest as worsening of symptoms.

 

 

Section 5.1 Pharmacodynamic Properties

 

The information on the Pharmacotherapeutic group was added:

other antifungals for topical dermatological use. ATC code: D01AE14.

 

The following wording in this section was rearranged, the information remains the same:

 

Current wording

 

Present wording

 

 

Ciclopirox Olamine is a broad spectrum antifungal agent which inhibits the growth of pathogenic dermatophytes, yeast and Malassezia furfur.  It has been shown in vitro to inhibit Pityrosporum ovale and Pityrosporum orbiculare, the yeast forms of Mallassezia furfur which have been implicated as the causative organisms in conditions such as dandruff and seborrhoeic dermatitis.  Ciclopirox Olamine exhibits some antibacterial activity against a variety of Gram-positive and Gram-negative bacteria. 

 

It also has anti-inflammatory activity as result of its ability to inhibit the synthesis of prostaglandins and leukotrienes.  Ciclopirox Olamine has been shown to significantly reduce arachidonic acid-induced ear-oedema test, as measured by percentage change from control inflamed ears in mice.

 

Stieprox is as effective and well tolerated as 2% ketoconazole shampoo in the treatment of severe dandruff and seborrhoeic dermatitis.

 

 

Mechanism of action

Ciclopirox olamine is a hydroxypyridone antifungal agent which is active in vitro inhibiting the growth of various fungal species including the yeast Malassezia furfur (formerly known as Pityrosporum ovale or Pityrosporum orbiculare). The latter has been implicated as a causative organism in dandruff and seborrhoeic dermatitis. Ciclopirox olamine also exhibits some anti-inflammatory activity.

 

Pharmacodynamic effects

Ciclopirox olamine 1.5% shampoo shows in vivo antifungal activity against Malassezia spp.

A clinical study has shown that ciclopirox olamine 1.5% shampoo significantly reduced the count of Malassezia furfur spp. in samples obtained from the scalp of subjects with dandruff and/or seborrhoeic dermatitis.

 

 

 

Section 5.2 Pharmacokinetic Properties

 

The following wording in this section was rearranged:

 

Current wording

 

Present wording

 

Following topical application of Ciclopirox Olamine as a 1% cream to human skin, about 1.3% of the dose is absorbed systemically.  Ciclopirox Olamine is excreted in urine with approximately 80% of an oral dose excreted as the glucuronide metabolite.  The biological half-life is approximately 1.7 hours.

 

The potential for systemic absorption of Ciclopirox Olamine from a wash-off shampoo containing 1.5% Ciclopirox Olamine is extremely low.

 

 

Absorption

The potential for clinically significant systemic absorption of ciclopirox olamine from a wash-off shampoo containing 1.5% ciclopirox olamine is expected to be low.

 

Distribution

Following oral administration of ciclopirox olamine to humans, affinity of ciclopirox olamine to serum proteins was found to be 96±2% in the concentration range of 0.01 to 11.0 µg/mL.

 

Metabolism

The metabolic patterns after oral and dermal application are similar. Glucuronidation of ciclopirox olamine appears to be the major form of its metabolism. 

 

Elimination

Following oral administration of ciclopirox olamine to humans, 96% of the administered dose is excreted within 12 hours. Ciclopirox olamine is excreted in urine with approximately 80% of an oral dose excreted as the glucuronide metabolite.

 

 

 

Section 5.3 was updated to include:

 

Carcinogenicity

A dermal carcinogenic study in mice at concentrations of 1% and 5% ciclopirox olamine formulated in polyethylene glycol 400 applied to the intact skin, twice a week, for one year, followed by a six-month non-treatment period was conducted. No tumours were observed in any of the mice at the site of application. Overall incidence of neoplasms was similar among the treated and control groups. In addition, there is no evidence that ciclopirox olamine is carcinogenic following oral or subcutaneous administration to a number of animal species.

 

Mutagenicity

Ciclopirox olamine did not cause gene mutation or chromosomal damage in several bacterial mutagen assays or in two mammalian assays. In a battery of in vitro genotoxicity assays with ciclopirox free acid, one assay was weakly positive. The weight of evidence provided by the in vitro and in vivo assessments suggest that ciclopirox does not present a genotoxic hazard to humans.

 

Reproductive Toxicology

Reproductive studies in mice, rats, rabbits and monkeys, at doses of ciclopirox olamine 10 times that of a topical human dose, have revealed no significant evidence of impaired fertility or harm to the foetus. There is evidence that ciclopirox olamine crosses the placental barrier in animals.

 

 

Updated on 7 June 2012 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

This approval was for the official addition of ‘Trading as Stiefel’ to the end of the MAH address in section 7.

Updated on 7 June 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

This approval was for the official addition of ‘Trading as Stiefel’ to the end of the MAH address in section 7.

Updated on 19 August 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).

Updated on 19 August 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).

Updated on 15 August 2009 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 7: Address of Marketing Authorisation Holder changed

Section 10: Date of revision updated

Updated on 15 August 2009 SmPC

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

Section 7: Address of Marketing Authorisation Holder changed

Section 10: Date of revision updated

Updated on 31 August 2007 PIL

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 1

Change from 'Stieprox Shampoo 1.5% w/w' to 'Stieprox 1.5% w/w Shampoo'

 

Section 2

Addition of 'For full list of excipients, see section 6.1'

 

Section 3

Change from 'Shampoo for cutaneous use' to 'Shampoo. Clear, straw to light orange coloured viscous shampoo'

 

Section 6.1

Change of excipients

 

Section 6.2

Change from 'None' to 'Not applicable'

 

Section 6.3

Change to '3 years'

 

Section 6.4

Change from 'None' to 'This medicinal product does not require any special storage conditions'

 

Section 6.5

Addition of 20ml pack

 

Section 6.6

Change from 'There are no special instructions for the use or handling of this product' to 'No special requirements'

 

Section 9

Change from '5th October 2001' to 'Date of first authorization: 5th October 2001  Date of last renewal: 5th October 2006'


Section 10

Change from 'March 2006' to 'August 2007'

Updated on 31 August 2007 SmPC

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1

Change from 'Stieprox Shampoo 1.5% w/w' to 'Stieprox 1.5% w/w Shampoo'

 

Section 2

Addition of 'For full list of excipients, see section 6.1'

 

Section 3

Change from 'Shampoo for cutaneous use' to 'Shampoo. Clear, straw to light orange coloured viscous shampoo'

 

Section 6.1

Change of excipients

 

Section 6.2

Change from 'None' to 'Not applicable'

 

Section 6.3

Change to '3 years'

 

Section 6.4

Change from 'None' to 'This medicinal product does not require any special storage conditions'

 

Section 6.5

Addition of 20ml pack

 

Section 6.6

Change from 'There are no special instructions for the use or handling of this product' to 'No special requirements'

 

Section 9

Change from '5th October 2001' to 'Date of first authorization: 5th October 2001  Date of last renewal: 5th October 2006'


Section 10

Change from 'March 2006' to 'August 2007'

Updated on 17 March 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 March 2007 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 30 August 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 August 2006 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 24 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie