Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd)
- Name:
Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd)
- Company:
Daiichi Sankyo Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/12/18

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Daiichi Sankyo Ireland Ltd

Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name BENETOR 10mg, 20 mg and 40 mg film-coated tablets | Active Ingredients olmesartan medoxomil |
Medicine Name BENETOR PLUS 20mg/12.5mg and 20mg/25mg film-coated tablets | Active Ingredients Hydrochlorothiazide, olmesartan medoxomil |
Medicine Name Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd) | Active Ingredients prasugrel hydrochloride |
Medicine Name Evista | Active Ingredients Raloxifene |
Medicine Name Lixiana 15mg, 30mg, 60mg film-coated tablets | Active Ingredients Edoxaban tosilate |
Medicine Name Lixiana Film-Coated Tablets | Active Ingredients Edoxaban tosilate |
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 12 December 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 12 December 2018 SmPC
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
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 May 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 May 2016 SmPC
Reasons for updating
- Change to section 8 - MA number
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 May 2016 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Updated on 17 May 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 17 May 2016 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 4 February 2014 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 8 - MA number
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Note: SPC updated to correct errors in formatted version, no other changes have been made.
4. Clinical particulars
4.4 Special warnings and precautions for use
Moved above Surgery paragraph :
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI
In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI. Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. (see sections 4.2, 4.8 and 5.1).
4.8 Undesirable effects
Reporting of suspected adverse reactions
Added (bold), deleted (strikethrough):
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 UK: www.mhra.gov.uk/yellowcard, or Ireland: IMB Phamacovigilance, Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.imb.ie, imbpharmacovigilance@imb.ie.
8. MARKETING AUTHORISATION NUMBER(S)
Deleted:
EU/1/08/503/015 Efient 10mg – 30x1 film-coated tablets
10. DATE OF REVISION OF THE TEXT
New Date:
18 December 2013
Updated on 2 January 2014 SmPC
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
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.2 Posology and method of administration
Added (bold):
Posology
Adults
Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking Efient should also take ASA daily (75 mg to 325 mg).
4.4 Special warnings and precautions for use
Added (bold):
Bleeding risk
In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Added :
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI
In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI. Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. (see sections 4.2, 4.8 and 5.1).
4.8 Undesirable effects
Added :
Bleeding Risk Associated with Timing of Loading Dose in NSTEMI
In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4). Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows:
Adverse Reaction |
Prasugrel Prior to Coronary Angiographya (N=2037) % |
Prasugrel At time of PCIa
(N=1996) % |
TIMI Major bleedingb |
1.3 |
0.5 |
Life-threateningc |
0.8 |
0.2 |
Fatal |
0.1 |
0.0 |
Symptomatic ICHd |
0.0 |
0.0 |
Requiring inotropes |
0.3 |
0.2 |
Requiring surgical intervention |
0.4 |
0.1 |
Requiring transfusion (≥4 units) |
0.3 |
0.1 |
TIMI Minor bleedinge |
1.7 |
0.6 |
aOther standard therapies were used as appropriate. The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel.
bAny intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below. Patients may be counted in more than one row.
dICH=intracranial haemorrhage.
eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996). Specifically, prasugrel did not significantly reduce the frequency of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from randomization in subjects receiving prasugrel prior to coronary angiography compared to patients receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography versus patients receiving the full loading dose of prasugrel at the time of PCI. Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. (See sections 4.2, 4.4, and 4.8)
10. DATE OF REVISION OF THE TEXT
New Date:
18 December 2013
Updated on 29 November 2013 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.2 - Pharmacokinetic 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes - Minor changes from renewal
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Added (bold) deleted (strikethrough):
Excipient with known effect: Each tablet contains 2.7 mg lactose.
For a the full list of excipients, see section 6.1.
4. Clinical particulars
4.1 Therapeutic indications
Added (bold):
Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
4.2 Posology and method of administration
Added (bold):
Hepatic impairment
No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child-Pugh class A and B) (see section 5.2). There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4). Efient is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).
Added (bold) deleted (strikethrough):
Paediatric populationChildren and adolescents
The safety and efficacy of Efient is not recommended for use in children below age 18 has not been established. No due to a lack of data are availableon safety and efficacy.
4.6 Fertility, pregnancy and lactation
Added (bold) deleted (strikethrough):
No clinical study has been conducted in pregnant or breast-feeding lactating women.
Added (subheadings):
Pregnancy
Breast-feeding
Fertility
4.7 Effects on ability to drive and use machines
Deleted (strikethrough):
No studies on the effects on ability to drive and use machines have been performed. Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
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 UK: www.mhra.gov.uk/yellowcard or Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.imb.ie, imbpharmacovigilance@imb.ie.
5.2 Pharmacokinetic properties
Added (bold) deleted (strikethrough):
Paediatric population:Children and adolescents:
Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Added (bold):
Date of first authorisation: 25 February 2009
Date of latest renewal: 13 November 2013
10. DATE OF REVISION OF THE TEXT
New Date: Blank
Added:
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Updated on 26 November 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 3 July 2013 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
4. Clinical particulars
4.2 Posology and method of administration
Patients ≥ 75 years old
Deleted:
The evidence for the 5 mg dose is based only on pharmacodynamic/pharmacokinetic analyses and no clinical data currently exist on the safety of this dose in the patients age group ≥ 75 years.
Patients weighing < 60 kg
Deleted:
Efficacy and safety of the 5 mg dose have not been prospectively assessed.
4.3 Contraindications
Added (bold):
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.8 Undesirable effects
Added (bold), deleted (strikethrough):
Patients ≥ 75 years old
In the phase 3 clinical trial, Non-CABG‑related TIMI major or minor bleeding rates for patients in two age groups were as follows:
Age |
Prasugrel 10 mg |
Clopidogrel 75 mg |
≥75 years (N=1785)* |
9.0% (1.0% fatal) |
6.9% (0.1% fatal) |
<75 years (N=11672)* |
3.8% (0.2% fatal) |
2.9% (0.1% fatal) |
<75 years (N=7180)** |
2.0% (0.1% fatal) a |
1.3% (0.1% fatal) |
|
Prasugrel 5 mg |
Clopidogrel 75 mg |
≥75 years (N=2060) ** |
2.6% (0.3% fatal) |
3.0% (0.5% fatal) |
*TRITON study in ACS patients undergoing PCI
**TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
a 10 mg prasugrel; 5 mg prasugrel if <60 kg
Patients < 60 kg
In the phase 3 clinical trial, Non-CABG‑related TIMI major or minor bleeding rates for patients in two age groups were as follows:
Weight |
Prasugrel 10 mg |
Clopidogrel 75 mg |
<60 kg (N=664)* |
10.1% (0% fatal) |
6.5% (0.3% fatal) |
≥60 kg (N=12672)* |
4.2% (0.3% fatal) |
3.3% (0.1% fatal) |
≥60 kg (N=7845)** |
2.2% (0.2% fatal) a |
1.6% (0.2% fatal) |
|
Prasugrel 5 mg |
Clopidogrel 75 mg |
<60kg (N=1391)** |
1.4% (0.1% fatal) |
2.2% (0.3% fatal) |
*TRITON study in ACS patients undergoing PCI
**TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Added (bold), deleted (strikethrough):
ClopidogrelSwitching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg. Similar or higher inhibition of platelet aggregation was observed with prasugrel. Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition. Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days. Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg. No data are available on switching from a clopidogrel loading dose directly to a prasugrel loading dose. In a study of 276 ACS patients managed with PCI, switching from an initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation for the 72 hour duration of the study.
Added:
In a 30 month study (TRILOGY–ACS) in 9326 patients with UA/NSTEMI ACS medically managed without revascularisation (non-licensed indication), prasugrel did not significantly reduce the frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel. Rates of TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and clopidogrel treated patients. Patients ≥75 years old or those below 60 kg (N=3022) were randomized to 5 mg prasugrel. As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes. Rates of major bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel. Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥ 75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
5.2 Pharmacokinetic properties
Added (bold):
Special Populations
Elderly: In a study of healthy subjects between the ages of 20 and 80 years, age had no significant effect on pharmacokinetics of prasugrel or its inhibition of platelet aggregation. In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥ 75 years of age) compared to subjects < 75 years of age. Prasugrel should be used with caution in patients ≥ 75 years of age due to the potential risk of bleeding in this population (see sections 4.2 and 4.4). In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was non-inferior compared to 10 mg.
Added (bold):
Body weight: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential risk of bleeding in this population (see section 4.4). In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
10. DATE OF REVISION OF THE TEXT
30 May 2013
Updated on 1 July 2013 PIL
Reasons for updating
- Improved electronic presentation
Updated on 7 November 2011 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.4 Special warnings and precautions for use
Deleted:
Therapeutic experience with prasugrel is limited in Asian patients. Therefore, prasugrel should be used with caution in these patients.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Added:
Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
10. DATE OF REVISION OF THE TEXT
24 October 2011
Updated on 31 October 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 17 June 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 6 May 2011 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
4. Clinical particulars
4.4 Special warnings and precautions for use
Added:
Hypersensitivity including angioedema
Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel. Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).
Thrombotic Thrombocytopaenic Purpura (TTP)
Added (bold) Deleted (strikethrough):
TTP has been reported with the use of other thienopyridinesprasugrel. TTP is a serious condition and requires prompt treatment. Efient was not associated with TTP in clinical trials supporting registration.
Sub heading updated:
4.6 Fertility, pregnancy and lactation
4.8 Undesirable effects
Added:
a. Summary of the safety profile
b. Tabulated summary of adverse reactions
Added (bold):
Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows:
Added (bold):
Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions
System Organ Class |
Common |
Uncommon |
Rare |
Not Known |
Updated on 8 October 2009 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.8 Undesirable effects
CABG-related bleeding
Added (bold) Deleted (strikethrough):
For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.34% (3 of 90 89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacodynamics
Added (bold) Deleted (strikethrough):
Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (129%) and within-subject (912%) variability with both 5 µM and 20 µM ADP.
6. PHARMACEUTICAL PARTICULARS
6.5 Nature and contents of container
Added (bold):
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.
8. MARKETING AUTHORISATION NUMBER(S)
Added:
EU/1/08/503/015 Efient 5mg - 30 film-coated tablet
EU/1/08/503/016 Efient 10mg - 30 film-coated tablet
10. DATE OF REVISION OF THE TEXT
21 September 2009
Updated on 30 June 2009 SmPC
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Added:
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
10. DATE OF REVISION OF THE TEXT
18 May 2009
Updated on 9 June 2009 SmPC
Reasons for updating
- Change in co-marketing arrangement
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
First SPC for new product.
10. DATE OF REVISION OF THE TEXT
25 February 2009
Updated on 22 May 2009 PIL
Reasons for updating
- Change in co-marketing arrangement
Updated on 5 March 2009 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 March 2009 PIL
Reasons for updating
- New PIL for new product