Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container
- Name:
Instanyl 50, 100 and 200 mcg nasal spray, solution in single-dose container
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/21

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Takeda Products Ireland Ltd

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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 15 January 2021 PIL
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 6 - date of revision
Updated on 8 January 2021 SPC
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 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 4.2, ‘Posology and method of administration’ ‘(see section 4.4)’ was added into the first paragraph.
In section 4.4, ‘Special warnings and precautions for use’ the following wording has been added:
Opioid Use Disorder (abuse and dependence)
Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl. However, iatrogenic addiction following therapeutic use of opioids is known to occur in the treatment of cancer related pain.
Repeated use of Instanyl may lead to Opioid Use Disorder (OUD). Abuse or intentional misuse of Instanyl may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g., major depression, anxiety and personality disorders).
Patients will require monitoring for signs of drug-seeking behavior (e.g., too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Updated on 4 February 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL – section 6 (Manufacturer)- Addition of:
Curida AS
Solbærvegen 5
NO-2409 Elverum
Norway
Date last revised 01/2020
Updated on 24 October 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 October 2019 SPC
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
The following changes have been made to the SmPC:
Section |
Changes |
4.8 Undesirable effects
|
Added Respiratory, thoracic and mediastinal disorders dyspnoea |
10. DATE OF REVISION OF THE TEXT |
10 October 2019 |
Updated on 22 August 2019 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Pharmacist's Guide to Dispensing provides Instanyl dispensing checklist and required actions before Instanyl Single Dose Nasal Spray is supplied
Updated on 22 August 2019 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Physician's Guide to Prescribing provides Instanyl prescribing checklist and required actions before Instanyl Single Dose Nasal Spray is prescribed
Updated on 11 July 2019 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Updated on 11 July 2019 SPC
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 4.6 - 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 4.9 - Overdose
- 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
The EMA have approved the Instanyl Renewal and during the procedure a number of changes were made to the SmPC and PIL.
Section |
Update |
4.2 - Posology and method of administration
|
Updated text in red:
Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse, misuse, addiction and overdose of fentanyl.
…
Elderly and Cachectic population Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age. Elderly patients may have a reduced clearance, a prolonged half‑life and higher sensitivity to fentanyl than younger patients. Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients. Cachectic patients may have reduced clearance of fentanyl. Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
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4.4 - Special warnings and precautions for use
|
Cardiac disease Fentanyl use may be associated with bradycardia. |
4.6 - Fertility, pregnancy and lactation
|
Pregnancy There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Instanyl should not be used in pregnancy unless clearly necessary and if the benefits outweigh the risks.
Following long‑term treatment, fentanyl may cause withdrawal in the new‑born infant. It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the newborn (neonate). If Instanyl has been administered, an antidote for the child should be readily available.
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4.7 - Effects on ability to drive and use machines
|
No studies of the effects on the ability to drive and use machines have been performed. However, opioid analgesics are known to impair the mental and/or physical ability required for driving or operating machinery. Patients undergoing treatment with Instanyl should be advised not to drive or operate machinery. Instanyl can cause somnolence, dizziness, visual disturbances or other adverse reactions which may affect their ability to drive or operate machinery.
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4.8 - Undesirable effects
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Deleted text:
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4.9 - Overdose
|
The signs and symptoms of fentanyl overdose are expected to be an extension of its pharmacological actions e.g. lethargy, coma and severe respiratory depression. Other signs may be hypothermia, decreased muscle tonus, bradycardia and hypotension. Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
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5.1 - Pharmacodynamic properties
|
The clinical studies demonstrated the efficacy and safety of Instanyl. No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients receiving low maintenance opioid dose tended to achieve effective pain relief with a lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose. This observation was most distinct for patients receiving Instanyl 50 micrograms.
|
5.2 - Pharmacokinetic properties |
The plasma protein binding of fentanyl is approximately 80%. The absolute bioavailability of Instanyl is approximately 89%.
|
10 – Date of Revision of the text |
01 July 2019 |
Updated on 22 March 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 March 2019 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 - 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section |
Changes |
4.3 Contraindications |
Added: Patients being treated with medicinal products containing sodium oxybate.
|
4.4 Special warnings and precautions for use |
Respiratory depression Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects. Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients
Chronic pulmonary disease In patients with chronic obstructive pulmonary diseases, fentanyl may have more severe adverse reactions. In these patients, opioids may decrease respiratory drive |
4.5 Interaction with other medicinal products and other forms of interaction |
Added Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).
The concomitant use of other central nervous system depressants, (including
|
4.8 Undesirable effects |
Added/ updated:
Nervous system disorders: Convulsions, loss of consciousness
Injury, poisoning and procedural complications: Fatigue, malaise peripheral oedema, withdrawal syndrome*, neonatal withdrawal syndrome
|
10. Date of Revision of the text |
5 March 2019
|
Updated on 29 May 2018 SPC
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 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
- In section 4.2, the following wording has been added: In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
- In section 4.4, information on hyperalgesia has been added
- In 4.8, drug dependence (addiction, drug abuse (frequency not known) and neonatal withdrawal symdrome (frequency not known) have been added
- In section 5.1, the following information has been added: Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical signs and symptoms may be manifest from these hormonal changes.
Updated on 20 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 March 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Change to section |
Details of change |
4.2 Posology and method of administration |
Text in blue removed and text in red added:
Posology Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Patients must be carefully monitored during the titration process. Titration to a higher dose necessitates contact with the health care professional.
The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Patients should wait ...
… Dose adjustment Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Dose adjustment of the background opioid therapy following pain reassessment should be considered
If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics. …
|
5.1 Pharmacological Properties |
Text in blue removed and text in red added:
Clinical safety and efficacy The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP). The patients had an average of 1 to 4 episodes per day while taking maintenance opioid therapy. Patients in the second pivotal study had earlier participated in the Instanyl pharmacokinetic study or in the first pivotal study.
The clinical studies demonstrated the efficacy and safety of Instanyl. No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients with low maintenance opioid dose tended to achieve effective pain relief with a correspondingly lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose. This was most distinct for patients ending on Instanyl 50 micrograms.
In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms; however, patients should be titrated to the optimal dose of Instanyl for treating BTP in cancer (see section 4.2). …
|
10. Date of revision of the text |
Updated text in red:
7th March 2017 |
Updated on 17 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 17 March 2017 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 3 October 2016 SPC
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section |
Details of change |
6.1 List of excipients |
Text in blue removed and text in red added:
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate
|
10. Date of revision of the text |
Updated text in red:
22nd September 2016 |
Updated on 30 September 2016 PIL
Reasons for updating
- Change of active ingredient
- Change to date of revision
Updated on 22 April 2016 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Amends and improvements to text have been made to sections 2, 4,2, 4.4, 5.1, & 6.3.
Updated on 3 March 2016 SPC
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 8 October 2015 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 8 October 2015 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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
Change to section |
Details of change |
6.4 Special precautions for storage |
Added: Keep the blister in the outer carton. Keep stored upright.
|
10. DATE OF REVISION OF THE TEXT
|
Changed to: 17th September 2015 |
Updated on 8 May 2015 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 30 March 2015 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 30 March 2015 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Change to section |
Details of change |
4.6. Fertility, pregnancy and lactation |
Changed: Breast-feeding Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least
|
4.8. Undesirable Effects |
Added: Fatigue, malaise peripheral oedema, withdrawal syndrome* *opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl |
10. DATE OF REVISION OF THE TEXT
|
Changed to: 05th March 2015 |
Updated on 2 March 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 17 September 2014 SPC
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
SECTION 7. MARKETING AUTHORISATION HOLDER- has the name change approval to the following:
Takeda Pharma A/S
Dybendal Alle 10
DK-2630 Taastrup
Denmark
SECTION 10. DATE OF REVISION OF THE TEXT
15th August 2014
Updated on 17 September 2014 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 12 May 2014 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 12 May 2014 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The minor wording changes in the updated Instanyl (fentanyl citrate) SmPC, contain general formatting and re wording with no impact on the actual context.
The updated Instanyl SmPC contains additional/amended information in the following section(s):
Change to section |
Details of change |
2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
Changed: ‘‘For a full list of excipients’’
to
‘’For the full list of excipients’’
|
4.2. Posology and method of administration |
Formatting: Font italic; No underlined headings.
Paediatric population section moved after Renal impairment section.
|
4.3. Contraindications |
Added: ‘’ Hypersensitivity to the active substance or to any of the excipients listed in section 6.1’’
|
4.4. Special warnings and precautions for use
|
Changed/exclusion: Respiratory depression “As with all potent opioids cClinical significant respiratory depression may occur with fentanyl”
to
Respiratory depression ‘’Clinical significant respiratory depression may occur with fentanyl’’
The exclusion of: ‘’Treatment with other nasally administered medicinal products When initiating treatment with Instanyl, alternative administration forms should be considered for concurrent treatment of concomitant diseases that can be treated via nasal administration’’.
|
4.8. Undesirable effects |
Formatting: Underlined headings.
|
5.1. Pharmacodynamic properties |
Changed: ‘’Pharmacodynamic effects’’ to ‘’Clinical safety and efficacy’’ |
5.2 Pharmacokinetic properties |
Formatting: Font Not italic; Underlined headings |
10. DATE OF REVISION OF THE TEXT
|
Changed to: 23rd April 2014
|
Updated on 17 April 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 17 April 2014 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to section |
Details of change |
4.3. Contradictions |
Added: ‘‘Patients without maintenance opioid therapy as there is an increased risk of respiratory depression’’
‘’Treatment of acute pain other than breakthrough pain’’ |
4.4. Special warnings and precautions for use |
Changed/Added: Fentanyl may produce bradycardia. Fentanyl should therefore be
Added: Serotonin Syndrome Caution is advised when Instanyl is coadministered with drugs that affect the serotoninergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.
Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
If serotonin syndrome is suspected, treatment with Instanyl should be discontinued’’
|
4.5. Interaction with other medicinal products and other forms of interaction |
Added: ‘’Coadministration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life threatening condition’’
Changed: ‘’Monoamine Oxidase MAO’’ to ‘’ a Monoamine Oxidase Inhibitor MAOI’’
|
4.6 Fertility, pregnancy and lactation
|
Changed: “Breastfeeding Fentanyl is excreted into human milk and may cause sedation and respiratory depression in the breast-fed infant. Fentanyl should only be used by breastfeeding women if the benefits outweigh the potential risks for both mother and child” to
‘’Breast-feeding Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 48 hours after the last administration of fentanyl’’
|
4.8. Undesirable effects
|
Added: ‘’Tabular list of adverse reactions’’
‘’The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience’’
‘’Injury, poisoning and procedural complications’’ Not known: Fall
General disorders and administration site conditions: Not known: ‘’Fatigue, malaise peripheral oedema’’
Gastrointestinal disorders Not known: ‘’ Diarrhoea’’
Nervous system disorders: Not known: ‘’ Convulsion’’
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 to Pharmacovigilance Section, Irish Medicines Board, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6767836, Website: www.imb.ie. e-mail:imbpharmacovigilance@imb.ie.
|
10. DATE OF REVISION OF THE TEXT
|
Changed to: 28th February 2014
|
Updated on 13 December 2013 PIL
Reasons for updating
- Change of manufacturer
Updated on 17 September 2013 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 16 September 2013 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
MAH name change approved to:
Takeda Pharma A/S
Langebjerg 1
DK-4000 Roskilde
Denmark
Tel.: +45 4677 1111
Updated on 11 July 2013 SPC
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: Nasal septum perforation has been added as a recognised side effect within the side effects table. Frequency- not known
Date of revision of text has been amended to 21st March 2013
Updated on 9 July 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 13 September 2012 SPC
Reasons for updating
- 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
100 and 200 mcg - 9th August 2012
50 mcg – 9th August 2011
Updated on 28 August 2012 SPC
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
50 mcg/dose : 23 months - unchanged
100 mcg/dose: 42 months
200 mcg/dose: 42 months
Updated on 23 August 2012 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 12 October 2011 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 October 2011 PIL
Reasons for updating
- New PIL for new product
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