A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Pfizer Manufacturing Belgium NV,
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Periodic Safety Update Reports
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
At the request of the European Medicines Agency;
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Additional risk minimisation measures
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Macugen is marketed, at launch and after launch all ophthalmological clinics where Macugen is expected to be used are provided with an updated physician information pack containing the following elements:
The Summary of Product Characteristics
Physician safety brochure
Intravitreal injection procedure video
Intravitreal injection procedure pictogram
The physician safety brochure should contain the following key elements:
a)The intravitreal procedure as it was performed in the pivotal clinical studies, along with any technical improvements
b)Use of povidone iodine
c)Performing lid scrubs
d)Use of anaesthetic to ensure patient comfort
e)Sterile techniques to minimize the risk of infection
f)Use of antibiotics
g)Techniques for the intravitreal injection
h)Key signs and symptoms of intravitreal injection related adverse events including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume
i)Management of intraocular pressure
j)Management of endophthalmitis
k)Understanding the risk factors involved in developing endophthalmitis
l)Reporting of serious adverse events(reminder aid)
The patient information should contain the following key elements:
m)Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure including endophthalmitis, increased intraocular pressure, retinal injury, intraocular haemorrhage, traumatic cataract, hypersensitivity and injection of excess volume
n)When to seek urgent attention from the health care provider